Regulation of Medical Implants in The EU and UK

House of Commons
Science and Technology

Committee
Regulation of medical
implants in the
EU and UK
Fifth Report of Session 201213
Report, together with formal minutes, oral and
written evidence
Additional written evidence is contained in
Volume II, available on the Committee website
at www.parliament.uk/science
Ordered by the House of Commons
to be printed 17 October 2012
HC 163
Published on 1 November 2012
by authority of the House of Commons
London: The Stationery Office Limited
15.50
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Caroline Dinenage (Conservative, Gosport)
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Stephen Metcalfe (Conservative, South Basildon and East Thurrock)
Stephen Mosley (Conservative, City of Chester)
Pamela Nash (Labour, Airdrie and Shotts)
Sarah Newton (Conservative, Truro and Falmouth)
Graham Stringer (Labour, Blackley and Broughton)
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Gregg McClymont (Labour, Cumbernauld, Kilsyth and Kirkintilloch East)
Stephen McPartland (Conservative, Stevenage)
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Jonathan Reynolds (Labour/Co-operative, Stalybridge and Hyde)
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Regulation of medical implants in the EU and UK
Contents
Report
Page
Summary
Introduction
Background
Regulation of medical implants

The MHRA
High profile medical device recalls
PIP breast implants
Metal-on-metal hip implants
Pre-market approval
Clinical data requirements
Cost and timescale of clinical trials
Transparency of evidence
Comparisons with the FDA
Notified bodies across Europe
Post-market surveillance
Reporting of adverse incidents
Manufacturers
Clinicians and patients
Registries
EU registry
Responding to adverse incidents
Auditing manufacturers
Conclusions
The MHRA
The regulation of medical implants
Conclusions and recommendations
7
9
10
10
11
12
12
16
18
21
22
27
27
27
28
31
32
34
36
39
39
40
42
Formal Minutes
47
Witnesses
48
List of printed written evidence
48
List of additional written evidence
49
List of Reports from the Committee during the current Parliament
50
Summary
Effective regulation of medical implants is of paramount importance to patient safety in the
UK and EU. The regulatory framework governing medical devices, which include medical
implants, is undergoing revision in the European Commission. Public attention has been
drawn to the shortcomings of the current system by high profile cases where faulty
implants have been withdrawn from the market, such as Poly Implant Prosthse (PIP)
breast implants and metal-on-metal hip implants. There have been several investigations
into the PIP breast implants scandal, and our inquiry has therefore focused on the
regulation of medical implants more widely.
Manufacturers seeking to place a new medical implant on the EU market must provide
some evidence on the safety and performance of the implant. Unlike with medicines, it is
not always necessary to generate clinical evidence about the new product: it is considered
acceptable to rely on equivalence data, in other words, published clinical investigations or
studies of similar devices. Essentially this means that implants can be used across the EU
on the basis of similarity to another implant rather than evidence of its own safety and
performance. While this would be acceptable (albeit not ideal) in some cases, we were
unimpressed with the extent to which reliance on equivalence data, rather than clinical
investigations, seemed to be acceptable. We were therefore pleased that the Commission
has proposed measures to make clearer what clinical information is required from
manufacturers and when equivalence data would be acceptable. We are also supportive of
proposals to strengthen auditing of manufacturers.
While we support the proposal that all implants placed on the EU market should be
registered centrally, we do not support the Commissions proposal to require
manufacturers with new implants to formally notify a central EU authority as this
increased bureaucracy could slow the approval process unnecessarily.
Transparency was a significant concern as we found that the evidence on safety and
performance of implants was not fully published by manufacturers and the operation of
notified bodies (who are responsible for approving manufacturers implants for use) was
not transparent. Perceptions of secrecy can be, and have been, very damaging to public
trust in the regulatory system. We have made several recommendations to improve
transparency and consider that the revised Medical Devices Directive should remove the
over-emphasis on confidentiality and operate from a default position of transparency and
openness. In addition, we support the Commissions proposals to strengthen the scrutiny
of notified bodies across Europe.
Once implants are on the EU market, post-market surveillance is intended to pick up any
faults. This requires reporting of adverse incidents by patients and healthcare professionals
as well as manufacturers. As there is some evidence of under-reporting, the Government
should make the reporting of adverse incidents mandatory for healthcare professionals.
We consider that implants approved on equivalence should be marked in a manner similar
to the Black Triangle Scheme, which is used to monitor new medicines that have been
approved for use on limited clinical data.
1 Introduction
1. Effective regulation of medical implants is of paramount importance to patient safety in
the UK. Recent high-profile cases where faulty medical implants were withdrawn from the
market, such as the Poly Implant Prosthse (PIP) breast implant and DePuys Articular
surface replacement (ASR) metal-on-metal hip implant, have brought into question the
effectiveness of current regulations.1 The withdrawal of the PIP breast implant from the
market prompted a number of reviews and inquiries in the UK. In May 2012, Lord Howe,
Departmental Under Secretary of State, Department of Health (DH), published a review of
the actions of the Medicines and Healthcare products Regulatory Agency (MHRA) and
DH in relation to the recall of PIP breast implants.2 Sir Bruce Keogh, NHS Medical
Director, appointed an Expert Group to conduct a wider review into the regulation of
cosmetic interventions, which published its report on 18 June 2012.3 The House of
Commons Health Select Committee published a report in March 2012 raising a number of
issues that it felt ought to be considered by these reviews.4 Although investigations into the
PIP breast implant will have implications for the regulation of medical devices, we decided
that an inquiry focusing on the regulation of medical implants more widely would be of
interest to Parliament and the public. We wanted to examine in particular how scientific
evidence is used in the approval of implants for use in humans and in post-market
monitoring.
2. Medical devices are products (excluding medicines) used in healthcare for the diagnosis,
prevention, monitoring or treatment of illness or disability.5 Medical implants are medical
devices inserted into the body and are governed by the Medical Devices Regulations 2002.
The Medical Devices Directive (MDD), the basis for the Regulations, is currently
undergoing revision in the European Commission. Public consultations took place in 2008
and 2010, and a proposal to revise the legal framework for medical devices was published
in September 2012. The Commission intends that this process shall lead to a fundamental
revision of the existing directives in order to simplify and strengthen the current EU legal
framework for medical devices.6 We hope that our inquiry will (i) influence the UK
Governments position when negotiating the text of the Commissions proposed revisions
in Council later this year; and (ii) inform the work of the European Scrutiny Committee,
which scrutinises draft EU legislation on behalf of the House of Commons.
3. We issued a call for evidence on 26 March 2012 seeking views on the following
questions:
Hip replacement fiasco highlights regulatory failings in Europe, The Guardian, 29 February 2012; Revealed: true
scale of breast implant scandal, The Telegraph, 31 Dec 2011
Health Committee, Sixteenth Report of Session 201012, PIP Breast implants and regulation of cosmetic
interventions, HC 1816
Poly Implant Prothse (PIP) breast implants: final report of the Expert Group, Department of Health, NHS Medical
Directorate
What we regulate, MHRA, www.mhra.gov.uk
Medical devices: Regulatory Framework, European Commission, ec.europa.eu
a) Are current legislation and regulations on safety and efficacy of medical implants fit for
purpose?
b) How effectively does the MHRA implement the Medical Devices Directive in the UK?
c) How could the legislation and regulations be improved?
d) How could the European Commission ensure that potential changes to the Medical
Devices Directive do not hinder the introduction of innovations in medical implants to
the market?7
4. The Committee received 19 written submissions. We took oral evidence from four
panels across two evidence sessions. On 23 May we took evidence from researchers,
clinicians and patient representatives: Dr Carl Heneghan, GP and Director of the Centre of
Evidence-Based Medicine at the University of Oxford; Dr Tom Joyce, Professor of
Orthopaedic Engineering in the School of Mechanical and Systems Engineering at
Newcastle University; Professor Stephen Westaby, Consultant Cardiac Surgeon, John
Radcliffe Hospital, Oxford; and Dr Suzette Woodward, Director of Patient Safety, National
Patient Safety Agency. On 13 June we took evidence from three panels of witnesses
representing implant manufacturers, notified bodies, the European Commission, and UK
Government. The first panel comprised of John Howlett, Head of the British Standards
Institute (BSi); Peter Ellingworth, Chief Executive of the Association of British Healthcare
Industries (ABHI); and Mike Kreuzer, Technical and Regulatory Executive Director,
ABHI. In the second panel we heard from Jacqueline Minor, Director of Consumer Affairs,
Directorate-General for Health & Consumers, European Commission. Finally, we took
evidence from Sir Kent Woods, Chief Executive of the MHRA and Lord Howe, DH.
5. We would like to thank those who provided written and oral evidence to this inquiry.
We also sought to take oral evidence from device manufacturers. Although they told us
that their views would be adequately represented by the Association of British
Healthcare Industries (ABHI), we are very disappointed that we were not able to take
oral evidence directly from manufacturers.
6. In chapter 2 of this Report we outline the requirements of the European Directives and
how implants are regulated in the UK as a result. Chapter 3 will consider the process of
certifying products for the EU market: whether sufficient evidence is gathered on an
implant before approval for use and whether tighter pre-market requirements would
introduce barriers to innovation and prevent the latest technology from reaching patients.
In chapter 4 we discuss how to improve the monitoring of medical implants once they are
on the market (post-market surveillance), and increasing coordination between EU
Member States. Finally, in chapter 5 we draw overall conclusions.
Committee announce new inquiry into the Regulation of medical implants, News, Science and Technology Select
Committee (Commons), www.parliament.uk
2 Background
Regulation of medical implants
7. The term medical device covers a wide range of products and instruments, such as
contact lenses, hospital beds, resuscitators and syringes.8 There are thousands of medical
devices used every day to diagnose, prevent, monitor and treat illness or disability. A
medical implant is a device intended to be either totally introduced into the body or to be
partially introduced into the body through surgery and to remain there for at least 30 days.9
Implants can be active (that is, requiring a power source, such as a pacemaker) or nonactive (such as a hip implant).10
8. The regulatory framework stems from three European Directives:
a) Directive 90/385/EEC on active implantable medical devices (AIMDD);11
b) Directive 93/42/EEC on medical devices (MDD);12 and
c) Directive 98/79/EC on in vitro13 diagnostic medical devices (IVDD).14
9. These Directives have been implemented into UK legislation by the Medical Devices
Regulations 2002, which consolidated all the existing medical devices Regulations into a
single piece of legislation and which came into force in June 2002.15 The Directives were
intended to serve the dual purpose of allowing manufacturers a single set of regulatory
requirements with which to access the entire EU market while providing users of devices
with a high level of confidence in the safety and performance of a device.16 The Directives
set out a list of essential requirements which all devices must meet before being placed on
the market, as well as imposing various other regulatory requirements upon the
manufacturer.17
10. The Directives are implemented by a competent authority in each Member State: in
the UK it is the Medicines and Healthcare products Regulatory Agency (MHRA), an
executive agency of the Department of Health (DH). The competent authority designates
notified bodies in that Member State to undertake specific tasks identified within EU
directives.18 Notified bodies assess higher-risk devices (such as implants) submitted for
What we regulate, MHRA, http://www.mhra.gov.uk/
Council Directive 93/42/EEC; Ev 7, para A3
10
Ev 41, para 2
11
This covers medical devices or parts of devices that are active and implantable, for example cochlear implants
12
This covers all medical devices
13
For use outside the body
14
This covers devices used in vitro (outside the body) for the examination of a specimen derived from the human
body, including reagents, instruments and specimen receptacles.
15
The Notified Body: Bulletin No. 6, MHRA, January 2006
16
Ev 32, para 3
17
Ev 32, para 4
18
Notified Bodies, Department of Business, Innovation and Skills, www.bis.gov.uk
approval by manufacturers. A notified body must be qualified to perform all the functions
for which it is designated, and notified body status may be withdrawn if the body fails to
meet expected criteria.19
11. In the UK, the MHRA oversees six notified bodies. These are: Amtac Certification
Services Ltd, BSi Healthcare, Intertek Testing and Certification Ltd, Lloyd's Register
Quality Assurance Ltd, SGS United Kingdom Ltd and UL International (UK) Ltd, all of
which are private companies.20 There are 78 notified bodies in Europe.21 Manufacturers are
free to seek verification of their medical device from any notified body capable of carrying
out the desired conformity assessment procedure, regardless of which Member State it is
in.22 According to the MHRA, demands for manufacturers to seek verification from
notified bodies overseen by their national competent authority would not only be
contrary to EC law but also against the principles of the single market.23 The MHRA also
explained why the crucial role for assessing the safety of devices is delegated to Notified
Bodies and not undertaken by publicly employed experts:
The rationale for employing such a system is largely down to the size and breadth of
the market for medical devices a typical estimate is that there are in excess of
400,000 different medical devices on the market in the EU. The medical devices
sector is constantly innovating, and new technologies appear at far greater rates than
they do in pharmaceuticals. Individual Notified Bodies are able to specialise in
certain areas and react to market demand, adding expertise and capacity where
required in a way that would not be possible for public sector bodies. The result is a
system that is efficient and able to rapidly undertake pre-market assessment; the EU
is widely recognised as being an innovation-friendly environment largely due to this
regulatory structure, and the Notified Body model of third-party involvement is
increasingly being adopted in various forms by regulatory authorities outside
Europe.24
12. Medical devices are classified by the Directives according to the level of risk they pose
to the patient. There are four classes of risk (I, IIa, IIb, and III), with the lowest risk devices,
such as stethoscopes, falling into Class I. Dental fillings, for example, are a Class IIa
device.25 Medical implants are always classified as Class IIb or III, because they are placed
within the body, require invasive surgery, and are designed to be in continuous use. The
risk category in which a device is placed determines (i) how a manufacturer would need to
demonstrate conformity with the relevant Directive; and (ii) the level of assessment
required.26 Class IIb and III devices must be assessed and verified by a notified body27
before they can be placed on the EU market.28
19
20
UK Notified Bodies under the Medical Devices Directives, MHRA, www.mhra.gov.uk
21
Q 56
22
23
24
Ev 35, para 29
25
Ev 39, para A5
26
Ev 33, para 11
13. Once compliance with the essential requirements has been established, the
manufacturer places a CE mark on the device and is free to place the device on the market
in all EU countries without further controls.29 The CE mark also represents a declaration
from the manufacturer that appropriate post-market surveillance measures are in place to
monitor the devices performance once it is in use. The CE mark is not used solely for
medical implants; other products such as toys and machinery that are subject to EU
directives must also be CE-marked.30 The Health Select Committee noted in its report PIP
Breast implants and regulation of cosmetic interventions that recent concern about the
safety of metal-on-metal hip implants suggest there is [...] cause for strengthening CE mark
requirements.31 The Committee also considered that with regards to the PIP implant, the
real issue [...] is the failure of the CE mark to provide adequate assurance that the product
[...] was appropriate to use32 and made recommendations to strengthen the CE mark
system.33 Pre-market approval will be discussed in more detail in chapter 3; including
whether there is enough transparency and public understanding of the approval system.
14. Once a device is on the market it is the manufacturers responsibility to ensure it is
performing as intended by collecting data about adverse events related to the device. The
manufacturer is required to report any incidents and update safety information, for
example, field safety corrective actions to the competent authority in the country in which
the incident occurred. Field safety corrective actions include product recalls, design
changes, software upgrades, and amended instructions for use, including patient
management for implants. The manufacturer must also alert:
the competent authorities of all countries in which the device is used;
the competent authority in their own country; and
the notified body that undertook the conformity assessment of the product.34
The MHRA
15. The MHRA is responsible for ensuring that medicines and medical devices work, and
are acceptably safe.35 Its role is to implement the provisions of the Directives, to appoint
and control Notified Bodies, to assess and authorise clinical investigations of non-CE
marked devices and to monitor and investigate adverse events and field safety corrective
27
Notified bodies are explained further in paragraph 10
28
Ev 32, para 5
29
Ev 32, para 7
30
Guide to the implementation of directives based on the New Approach and the Global Approach, Luxembourg:
Office for Official Publications of the European Communities, 2000, L-2985 Luxembourg
31
interventions, HC 1816, para 62
32
33
34
Medical devices Guidance document: Guidelines on a Medical Devices Vigilance System. Revision 7 of MEDDEV 2.121, March 2012
35
About us, MHRA, www.mhra.gov.uk
10
actions (including recalls) occurring in [the UK].36 The MHRA explained that clinical
investigations are generally likely to be required for medical implants and that the role of
the MHRA is to assess the technical and clinical evidence provided by the manufacturer to
ensure that there are no public health or public policy reasons whereby the proposed
clinical investigation should not proceed.37
16. Once a device is on the market, the MHRA has responsibility for investigating adverse
incidents reported either by manufacturers (who are responsible for post market
surveillance) or by healthcare professionals and members of the public.38 As a result of
these investigations the MHRA will take further action as appropriate, including recalling
faulty products and offering advice to the health service, primarily through Medical Device
Alerts, but also through safety pamphlets, posters, and bulletins.39 The MHRA considers
that it has an important role in working with professionals and the public, not only to
inform but also to influence their behaviour.40
High profile medical device recalls

17. Subsequent chapters of this report will discuss the regulatory framework for medical
implants in more detail. However it is worth briefly setting out background information on
the recall of PIP breast implants in early 2012 and recall of the DePuy metal-on-metal hip
implant systems in 2010 as these two cases were frequently raised.
PIP breast implants
18. In March 2010, the French regulator Agence Franaise de Scurit Sanitaire des
Produits de Sant (AFSSAPS) found that the French company Poly Implant Prothses
(PIP) had been using non-authorised silicone in the manufacture of breast implants. The
CE mark for PIP implants was consequently withdrawn and the MHRA indicated that the
implants should no longer be used in the UK.41 In relation to the PIP implant recall, Lord
Howe, Parliamentary Under-Secretary of State, Department of Health, stated we must
always remember that we are dealing there with a clear case of fraud. It was clear from my
investigation that no amount of regulation could have prevented deliberate fraud of that
kind.42 He added there is no criticism of the notified body in relation to the PIP
manufacturer; they did their job as far as we can see perfectly adequately, but the
manufacturer was out to hoodwink everybody.43
19. As stated previously, this inquiry was not intended to examine the PIP implant issue
directly as there have been several investigations into the matter.
36
Ev 32, para 9
37
Ev 33, para 20
38
Ev 34, para 21
39
Ibid.
40
Ibid.
41
42
Q 148
43
Q 148
11
Metal-on-metal hip implants

20. The hip is one of the largest joints in the human body and is a ball-and-socket joint.
In healthy hips the bones are covered with smooth cartilage that enables the femoral head
(the ball) and the acetabulum (the socket) to glide painlessly against each other.44 The
bones are connected to each other with ligaments (bands of tissue) that are lubricated with
fluid to reduce friction.45 Hip replacement can become necessary when the joint is
damaged, for example because of arthritis.46 Hip implants can either be total hip
replacements or hip resurfacing implants and in metal-on-metal hip implants both the ball
and socket are made from metal.47 A hip resurfacing implant is smaller and does not
require as much of the femur (thighbone) to be removed as a total hip replacement. It is
therefore thought to be more suitable for younger patients, who are more likely to need
another replacement; because of natural wear, hip implants typically last 10-20 years.48 Hip
implants can be made from a range of metal alloys, high-grade plastics and polymeric
materials.49
21. In August 2010, two metal-on-metal hip implants manufactured by DePuy were
recalled worldwide because data from the National Joint Registry (NJR) of England and
Wales showed that more people than anticipated had experienced problems and required a
second hip replacement surgery.50 These implants were not the only metal-on-metal hip
implants in use, but metal-on-metal hip implants with a large diameter, such as DePuys
implants, appeared to cause more problems.51 Both the DePuy ASR52 hip resurfacing and
total hip replacement implants had been certified for the EU market by the UKs British
Standards Institute (BSi) in 2003.53 In the next chapter we will consider pre-market
approval in more detail, including differences between the EU and FDA regulatory
systems.
44
Hip resurfacing, American Academy of Orthopaedic Surgeons, orthoinfo.aaos.org
45
Hip replacement: introduction, NHS Choices, www.nhs.uk
46
Inflammatory arthritis of the hip, American Academy of Orthopaedic Surgeons, orthoinfo.aaos.org
47
Metal-on-metal hip implants, US Food and Drug Administration, www.fda.gov
48
Hip resurfacing, American Academy of Orthopaedic Surgeons, orthoinfo.aaos.org
49
Hip implants, American Academy of Orthopaedic Surgeons, orthoinfo.aaos.org
50
ASR hip replacement guide, DePuy, www.depuy.com
51
Metal-on-metal hip implants, MHRA, www.mhra.gov.uk
52
Articular surface replacement
53
Out of joint: the story of the ASR, British Medical Journal, 15 May 2011, www.bmj.com
12
3 Pre-market approval
Clinical data requirements
23. The regulatory framework for medical implants must strike a balance between ensuring
patient safety and encouraging innovation, so as to ensure timely patient access to safe and
effective technology. Although medicines and medical devices are both regulated in the UK
by the Medicines and Healthcare products Regulatory Agency (MHRA), their regulation
differs in several crucial ways.54 Medicines must receive a licence, or market authorisation,
from the MHRA before they can be sold in the UK.55 The MHRA must also authorise
clinical trials of new medicines, if the trials are to be conducted in the UK. Medicines are
normally subject to three phases of trial before reaching market:
Phase 1 trials are relatively small trials (less than 100 participants) to test for side
effects at different doses. They are normally conducted on healthy individuals.
Phase 2 trials are larger (several hundred participants) and include patients with
particular conditions. They test how the medicine works in patient populations
and identify common side-effects.
Phase 3 trials are large-scale trials that can include hundreds or even thousands of
participants. They test the medicine in the general population. These trials gather
detailed information about side effects and efficacy, and the results inform the
labelling and patient information provided when the medicine is made available on
the market. 56
24. The clinical data requirements for medical devices to be sold on the European market
are significantly less stringent. Medical devices are not automatically subject to a clinical
trial, although they are always tested for mechanical and/or electrical safety before use in
patients.57 Before a medical device can be sold on the European market, the manufacturer
must verify that the device conforms to essential requirements for medical devices, which
concern the the safety and performance of the device and the amount and type of
information given to the user of the device by way of the label and instructions for use.58
Manufacturers of Class I devices can verify this through self-certification, but for all other
devices verification by a notified body is required.59 Given that medical implants always fall
into the highest risk categories (Class IIb or III), manufacturers must submit clinical data
to a notified body for evaluation before selling their products on the EU market.60
Although the decision on whether to run a new clinical trial of the device is made by the
manufacturer, the notified body can challenge this decision.61 Based on the information
54
What we regulate, MHRA, www.mhra.gov.uk
55
Medicines & Medical Devices Regulation: What you need to know, MHRA, April 2008, www.mhra.gov.uk
56
57
58
Ev 32, para 4
59
Ev 32, para 5
60
Ev 33, para 11
61
Q 44
13
provided by manufacturers, notified bodies then assess a devices short-term compliance

with the essential requirements based on the technical data submitted.62 Clinical data
provided by manufacturers can come from:
published clinical investigations or other studies of similar devices in the scientific

literature (this is referred to as equivalence data63);
clinical experience of the medical device or a similar device; or
the results of a specifically designed clinical investigation of the device: these would
typically be required where a medical implant has new design features or uses new
materials.64
25. As part of the pre-market approval process, notified bodies also audit manufacturers to
ensure their facilities comply with the essential requirements of the Directives. The MHRA
explained that:
When undertaking conformity assessment for class IIb implants a Notified Body
typically carries out a detailed assessment of the manufacturing facility to look into
design, manufacturing and inspection of the devices concerned. They also cover
other general requirements such as staff training and the handling of complaints.
They will also sample technical documentation for compliance from the range of
products being manufactured. These assessments normally take place annually to
ensure ongoing compliance with the requirements of the legislation.
For class III implants, as well as the assessments at the facilities as outlined for the
class IIb products, there is also a requirement for the Notified Body to review the
technical documentation of each product to ensure that it is in compliance with the
essential requirements. Dependent upon the product this will cover such areas as
safety, performance, biological properties, sterilisation, software and labelling.65
26. We heard concerns about relying on equivalence data for pre-market approval of
medical implants. The Centre for Evidence-Based Medicine and the British Medical
Journal (BMJ) considered that the normal level of evidence required to demonstrate the
effectiveness or safety of new medicines is not required for medical devices under the
current legislation.66 They stated that the level of clinical data required for a new device
can be minimal [...] and could be obtained in a few days, contrasting markedly with the
type and extent of clinical trial data required for new drugs.67 Furthermore, they
considered that regulators find it incredibly difficult to judge if a device is equivalent to
another on the market and that as a result, the current system of equivalence and the
acceptance of studies of other devices reported in the scientific literature are one of the
62
Q 49
63
Q 43
64
Ev 33, para 15
65
Ev 33, paras 1314
66
Ev w4
67
Ibid.
14
main drivers of poor quality under-researched devices on the market today.68 The Faculty
of Pharmaceutical Medicine of the Royal Colleges of Physicians stated that use of
equivalence data was flawed because there may be unpublished safety issues with the
already certified device and that subtle differences between the two devices may result in
safety and effectiveness differences that are not explored clinically prior to marketing the
[new] device.69 Additionally, as time goes on, each iteration of a device rests its case on a
previous iteration, each a little different to the next one: after several years, devices may be
approved that are very different to the original marketed device.70 Professor Stephen
Westaby, cardiac surgeon at the John Radcliffe Hospital, Oxford, also emphasised the
importance of gathering evidence from human clinical trials, noting that devices tested in
animal studies would not necessarily work in a human in the same way.71 The perception
that manufacturers of medical devices do not need to provide proof that they work has
also been reported in mainstream media.72
27. Conversely, there was opposition to adopting the pharmaceutical approach of
gathering data from clinical trials. Professor Alan Murray, Professor of Cardiovascular
Physics, Newcastle University, stated that conducting the same style of clinical trial as for
drugs [...] is often not possible, because with drugs small doses can be given initially to
assess tolerance and side effects, and the drug can be stopped at any time. Once a medical
device has been implanted it is very difficult [to] remove.73 Another problem is the time
needed to run a clinical trial: John Howlett, Head of BSi, explained that as medical implants
are designed to last for several years, a clinical trial assessing the wear of such an implant
would similarly have to last for several years.74 He stated that short-term compliance on
wear and fatigue is all carried out in the design phase and that data on long-term
performance must be collected once the implant is in use (post-market surveillance; see
chapter 4 for further discussion). Dr Thomas Joyce, Reader in Biotribology, Newcastle
University, agreed but argued that the wear of implants such as artificial joints should be
more routinely tested, and that data generated from these tests should be publicly
available.75 Professor Westaby added:
With long-term medical implants such as hips and blood pumpsartificial lungs are
on the wayand all sorts of exciting technology, you would have to embargo
widespread use for something like 10 to 15 years before you got your outcome data
[..] you simply cannot say [to patients], We have to wait 10 years for long-term trial
data.76
28. The MHRA stated medical devices are unlike pharmaceuticals, in that their
development is generally based on principles of engineering, rather than of chemistry and
68
Ibid.
69
Ev w14
70
Ibid.
71
Q6
72
For example, Are diet pills too good to be true?, Glamour, July 2012, p270
73
Ev w10, para 1
74
Q 49
75
Ev 44
76
Q7
15
pharmacology and, as such, greater reliance can be placed on laboratory tests rather than
clinical studies in patients.77 Sir Kent Woods, Chief Executive of the MHRA, gave three
reasons for the differences in regulation of medical devices and medicines:
First, the way they are innovated. They are innovated in a rather iterative way with
progressive, relatively small changes in technology and refinement, perhaps as
frequently as every year or two, which is quite unlike the situation with
pharmaceuticals.
The second point is about their sheer multiplicity. When we look at pharmaceuticals
we are talking about the low thousands; when we look at medical devices we are
looking at hundreds of thousands in the EU. Therefore, the regulatory system has to
be able to cope with that.
The third and perhaps most important difference is the way in which they fail when
they give rise to problems. In contrast to pharmaceuticals, the areas where medical
devices give us problems are, first, in relation to sporadic manufacturing problems,
which are not easily picked up at the market authorisation step; and, secondly,
particularly in terms of implantable devices, the way they wear over time, and all of
them will over time. Again, that is on a time scale that is not easy to pick up in preclinical studies.78
The long-term success of a medical implant also depends on idiosyncratic factors such as
the way they are used and the way patients are selected for particular devices, 79 as well as
the skill of the surgeon implanting the device,80 and patient compliance with caring for the
medical implant following the operation (such as taking medication to prevent blood
clotting following the insertion of a heart valve).81
29. Sir Kent added that the MHRAs view has been that, in principle, the Medical Devices
Directives under the new approach are appropriate, but that there are areas where it
would like to see a greater degree of consistency of application and rigour across the piece
in certain areas.82 For example, the MHRA considered that reducing the extent to which
manufacturers are able to rely on equivalence was critical.83 The Commissions 2012
Proposal for a Regulation on medical devices introduced the regulatory instrument of
common technical specification (CTS), to allow the Commission to further specify the
general safety and performance requirements [...] and the requirements on clinical
evaluation and post-market clinical follow-up.84 However equivalence remains an option
as the requirements still leave manufacturers the possibility of adopting other solutions
77
Ev 34, para 26
78
Q 123
79
Q 123
80
Ev 51
81
Q 20
82
Q 123
83
Ev 36, para 38
84
Proposal for a Regulation of the European Parliament and of the Council on medical devices, and amending
Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009
16
that ensure at least an equivalent level of safety and performance.85 The proposal stated
that:
Equivalence can only be demonstrated when the device that is subject to clinical
evaluation and the device to which the existing clinical data relates have the same
intended purpose and when the technical and biological characteristics of the devices
and the medical procedures applied are similar to such an extent that there would be
not a clinically significant difference in the safety and performance of the devices.
In the case of implantable devices and devices falling within class III, clinical
investigations shall be performed unless it is duly justified to rely on existing clinical
data alone. Demonstration of equivalence [...] shall generally not be considered as
sufficient justification within the meaning of the [previous sentence].86
Cost and timescale of clinical trials
30. Clinical trials take a significant amount of time to set up. For studies taking place in
NHS settings, approval is needed both from the National Research Ethics Service, and for
each local NHS site taking part in the study.87 The MHRA must also approve clinical
protocols for studies of non-CE marked products.88 Professor Westaby suggested that
gaining ethical approval for clinical trials in the UK was difficult, and that there are very
definitely tendencies to direct your research to areas where you are likely to get ethics
permission early for certain things. 89 He stated: I can do far more in Greece that is wholly
ethical much faster than I can in the UK [...] I can get ethics approval for [clinical research]
in Greece, where it would take me two years in Oxford.90 He also lamented the cost of
conducting trials:
[An] artificial heart is an example of the epitome of implantable devices [...] to test
one of these miniature artificial hearts costs a company $1 million per week [...]I
have a device, and I want it to go into humans soon, but my little company cannot
afford $1 million, full stop [...] the clinical trials have got to be made accessible and
far cheaper than they are now, because right now it just does not work [...] In my
view, the NHS has got to support it far better than it does.91
31. The decision on whether to run a new clinical trial of a device is, in the first instance,
made by the manufacturer.92 Dr Carl Heneghan, Centre of Evidence-Based Medicine,
University of Oxford, pointed out that such high costs do not incentivise manufacturers to
85
86
87
Before applying, National Research Ethics Service, www.nres.nhs.uk
88
Ev 32, para 9
89
Q 16
90
Q 16
91
Q9
92
Q 44
17
run trials, when equivalence data is often acceptable.93 Mr Howlett, BSi, agreed that
manufacturers could be disincentivised from running new trials because clinical trials are
expensive to run and could delay patient access to life-saving technology.94 However he
added that although trials are by nature costly for the manufacturer to set up the BSi as a
notified body would challenge the manufacturer on the availability of the data.95 The
Association of British Healthcare Industries (ABHI), representing medical devices
manufacturers, stated that:
Clinical evaluation of a device is required when demonstrating conformity with
relevant essential requirements. For medical implants, this process is particularly
important, as the characteristics of a device when implanted in the body need to be
understood and documented. ABHI believes the revision of the MDDs should see
the system become more prescriptive in setting out when manufacturers need to
undertake clinical investigations, or to what extent they are able to rely on existing
scientific literature claiming equivalence with an existing device.96
The ABHI added that since notified bodies are responsible for assessing clinical evaluation
by manufacturers as part of conformity assessment, ensuring that appropriate clinical
investigations have taken place it believed that by improving the coordination of Notified
Bodies, the scrutiny of clinical evaluation will be greatly improved.97
32. Jacqueline Minor, Director of Consumer Affairs, Directorate-General for Health &
Consumers, European Commission, stated that the Commission was considering how to
make early scientific advice available to producers and to notified bodies and stated we
will have a scientific panel, and anyone developing a novel technology will be able to go to
that scientific panel to ask about the kinds of evidence they will need to bring forward to
support its safety when the time comes for conformity assessment and placing it on the
market.98
33. The difficulty of conducting clinical trials in the UK is not a newly identified problem
and our predecessor Committee regularly encountered criticisms of the system.99 In
January 2011 the Academy of Medical Sciences published A new pathway for the regulation
and governance of health research.100 A key recommendation was to create a Health
Research Agency (HRA) to improve the UK environment for clinical trials, including
working with the MHRA and the National Institute for Health Research (NIHR) to unify
the process by which ethical approval is given to studies.101 Other recommendations
included improving access to patient data that protects individual interests and allows
93
Q6
94
Q 44 and 49
95
Q 44
96
Ev 43, para 19
97
Ev 43, para 20
98
Q 107
99
For example, Science and Technology Committee, Seventh Report of Session 200910, Bioengineering, HC 220
100
A new pathway for the regulation and governance of health research, The Academy of Medical Sciences, January
2011
101
Health Research Authority, Health Research Authority, www.hra.nhs.uk
18
approved research to proceed effectively, and embedding a culture that values research
within the NHS.102 The HRA was established in December 2011 as a Special Health
Authority, and acquired the existing National Research Ethics Service (NRES).103 The
Queens Speech in May this year included a draft bill to modernise adult care and support
in England: as part of this draft bill the HRA would be established as a non-departmental
public body (NDPB).104 The Clinical Trials Directive is also being revised by the European
Commission, which, in July 2012, proposed a Regulation to boost the EUs attractiveness as
a place to do clinical research.105 The legislative proposal will be discussed in the European
Parliament and in the Council and is expected to come into effect in 2016.106
34. Ideally, all medical implants approved for use on the EU market would be subject to
rigorous clinical investigations prior to introduction but it is not practical to do this for
every implant and there are circumstances where reliance on equivalence data may be
acceptable. Nonetheless, it appears that the existing regulatory framework may have the
effect of encouraging manufacturers to rely on equivalence data rather than evidence
from clinical trials. This is compounded by the difficulties of conducting clinical trials
in the UK. We do not advocate a pharmaceutical style approach to regulation. We
endorse the approaches already being taken: (i) the proposed revisions to the Medical
Devices Directive make clearer when equivalence data is or isnt acceptable and
strengthen scrutiny and challenge of manufacturers decisions; and (ii) the
environment for clinical trials should be improved, not just in the UK but across
Europe.
35. We welcome the European Commissions proposal to make scientific advice
available to manufacturers and notified bodies when placing new implants on the
market.
36. The establishment of the Health Research Authority (HRA) is a welcome step
towards improving the regulation and governance of health research. We expect the
HRA to tackle the difficulties of setting up clinical trials in the UK. We intend to
scrutinise the HRA and its work and we recommend that the Government publishes an
update on the progress of the HRA in improving the environment for clinical trials in
December 2012, a year after its establishment.
37. According to the MHRA, very little information is available about a medical device
throughout its lifetime clinical evaluations, conformity assessment, adverse incidents and
post-market surveillance plans, for example, are generally not published.107 This
102
A new pathway for the regulation and governance of health research, The Academy of Medical Sciences, January
2011
103
Health Research Authority, Health Research Authority, www.hra.nhs.uk
104
Draft Bill to modernise adult care and support in England included in Queens Speech, Department of Health, 9
May 2012, www.dh.gov.uk
105
Fostering EU's attractiveness in clinical research: Commission proposes to revamp rules on trials with medicines,
European Commission press release, 17 July 2012
106
Clinical trials, European Commission, ec.europa.eu
107
Ev 37, para 52
19
opaqueness was considered to contribute [...] to a degree of unease about the regulatory
system.108 Dr Heneghan Centre for Evidence-Based Medicine, expressed frustration that
the transparency of pre-market clinical data is much greater in the US than in Europe.109
The joint submission from the Centre for Evidence-Based Medicine and the British
Medical Journal (BMJ) stated:
In the absence of publicly available regulatory data, it is left to the device
manufacturers to decide what enters the public domain on their website or as a
scientific publication. This means that clinicians are dependent on the manufacturers
to provide them with data about their implant and what they decide to publish [...]
The lack of data does not help clinical decision making. Indeed, the lack of clinical
studies or trials makes it an almost impossible task for health technology appraisal
[...] In the worst case scenarios, patients may be subject to an intervention that is not
appropriate for them. In addition the lack of clinical data means it is difficult if not
impossible for commissioners of health care to understand the true cost of
interventions beyond the initial cost impact analysis.110
Professor Westaby explained that clinicians like him did not have access to the clinical data
used in approving a medical device for the European market.111 When we asked Professor
Westaby about how increased transparency might assist clinicians choosing an implant for
their patients, he explained that published data from medical implants was available in
journals, but that a lot of what is published in terms of clinical trial is done by enthusiasts
in the best units under ideal conditions. 112 This refers to the practice of cherry picking,
or selective publishing, of clinical data whereby positive results are reported and negative
results are not. This problem goes beyond medical implants to many areas of medicine and
has led to calls for clinical trial registers. Professor Westaby considered that the data
collected after a medical implant has been placed on the marketpost-market
surveillancewas more instructive than clinical trials and that the use of registries to
track patients and implants in post-market surveillance was very important.113 Postmarket surveillance and registries are discussed in chapter 4.
38. Mr Howlett, BSi, stated that the notified bodies cannot make [clinical] information
public, but, in the interests of transparency, I would support that.114 He considered that
the way an implant was approved for sale should be made clearer, so that the public, in the
interests of patient safety, can visibly see the route and compliance either through clinical
literature or trials.115 Dr Suzette Woodward, Director of Patient Safety, National Patient
Safety Agency, did not consider that increased transparency would pose a problem for
patient confidentiality, provided the data were passed through certain level of filter so that
108
Ibid.
109
Q5
110
Ev w3
111
Q 13
112
Q 13
113
Q 13
114
Q 45
115
Q 45
20
individual patients would not recognise themselves in something that was made public.116
Sir Kent Woods acknowledged that greater transparency will influence the way clinicians
do their jobs; it will influence the way patients make decisions about healthcare.117 He
explained that the Directives require that information obtained by regulators is
confidential, but that he would support a change to this in the revision of the Directives.118
The MHRA was clear that the revision of the Medical Devices Directives provides an
opportunity for a substantial change in the availability of information about medical
devices and the regulatory system and that a key aim for the UK in the revision is
therefore to drive far greater publication of information in a format that is useful for the
public, as well as regulators and manufacturers.119 This was generally prohibited by
explicit confidentiality requirements currently within the Directives that the MHRA
wished to see removed120 (this is further explored in paragraph 93).
39. The importance of transparency has been recognised by the European Commission.
Ms Minor stated:
It is very difficult [...] for anyone to know what devices are on the market; what
evidence was used to support their safety; and what information is available about
the associated risks and the incidents they might have provoked. We are planning to
have a central registry in which all manufacturers and all devices will have to be
listed. For each device, there will be some standard information, such as the name of
the notified bodies, the class of risk, and the unique device identifier, when we have
that. There will also be a summary of performance and clinical data. For the first
time, for example, clinicians will be able to have access to the clinical data which
supported the certificate granted to the device.121
The Commissions published proposal stated that a lack of transparency is one of the
main shortcomings of the current system and proposes an obligation for manufacturers
of high-risk devices to make publicly available a summary of safety and performance with
key elements of the supporting clinical data.122
40. Transparency should be the default position in the approval of medical implants: it
is particularly important where some of the key players influencing public health
manufacturers and notified bodiesare private organisations not accountable to
Parliament or subject to Freedom of Information requests. Greater transparency would
improve public confidence in the system and support decision-making by patients and
healthcare professionals. We are disappointed that there is a lack of transparency in the
current regulatory system and we urge the UK Government to take a lead in increasing
transparency.
116
Q 15
117
Q 137
118
Q 133
119
Ev 37, para 52
120
Ibid.
121
Q 109
122
21
41. The Commissions proposals are a step in the right direction, but do not go far
enough. All clinical data used in the approval of a medical implant should be made
publicly available without identifying patients or clinical trial participants. For
products currently on the market, data should be published immediately. It should be
clear when medical implants have been approved using equivalence data and when
clinical investigations have been conducted on that implant prior to market approval.
42. In addition, regardless of whether an implant is approved for use or not, any new
clinical data generated about that implant should be published. It is as scientifically
useful to know what doesnt work as it is to know what does work.
43. Comparisons were made with the Food and Drugs Administration (FDA), the public
body that conducts pre-market approval for medical devices in the USA.123 Dr Heneghan,
Centre for Evidence-Based Medicine, University of Oxford, provided examples of several
medical implants that were rejected by the Food and Drugs Administration (FDA) but
were approved for the European market.124 As stated in chapter 2, one of the implants
rejected by the FDA but approved in the EU was the DePuy metal-on-metal ASR hip
resurfacing implant. The US Food and Drugs Administration (FDA) also approved the
total hip replacement, although it rejected the resurfacing implant.125 The New York Times
reported that the FDA had told Johnson & Johnson (DePuys parent company) in August
2009 that company studies and clinical data submitted to gain approval in the United
States to sell the model available overseas were inadequate to determine the [resurfacing]
implants safety and effectiveness.126Another DePuy metal-on-metal hip implant, the ASR
total hip replacement system, was approved in both the US and EU. Both of these implants
were recalled worldwide in 2010 due to higher than expected revision rates.127 The MHRA
pointed out that the DePuy ASR hip was placed on the market in both the US and the EU,
having satisfied the pre-market requirements of both regulatory frameworks and yet [...]
problems with the implant were first identified in the UK.128
44. Further to this, Professor Westaby explained that because of the differing evidence
requirements, some US companies used the European market to run clinical trials of their
medical implants. Data from these trials are then presented to the FDA for approval in the
US.129 Professor Westaby considered this to be of benefit to patients, and stated I can use
sophisticated devices many years before my colleagues in the States and Japan,130 in other
words, current regulations allow EU patients access to new medical devices several years
before other countries. He cautioned against increasing the requirements for approving
123
Ev 38, para 54
124
Q4
125
ASR hip replacement recall guide, DePuy, www.depuy.com
126
Hip implant US rejected was sold overseas, New York Times, 14 February 2012, www.nytimes.com
127
ASR hip replacement recall guide, DePuy, www.depuy.com; Revision rates refer to the additional surgery required
when an implant needs to be repaired or replaced.
128
Ev 38, para 54
129
Q5
130
Q2
22
devices, stating the NHS is becoming so stiff in bureaucracy that it can hardly move. If we
are not very careful, it will just grind to a halt.131 The Faculty of Pharmaceutical Medicine
of the Royal Colleges of Physicians explained that on average, the [FDA] process delays
approval of medical implants [...] by two years compared to the EU, and that there have
been no safety issues identified post-approval in the EU that were "caught" by the longer
and more rigorous approval process in the US.132 Sir Kent Woods, MHRA, considered
that currently that balance is about right.133
45. There is insufficient evidence that the Food and Drugs Administrations (FDA)
more onerous procedures for granting market approval to medical implants have
resulted in greater patient safety. The FDA system also operates more slowly and thus
delays patient access to medical implants, which is, in itself, a threat to patient safety.
Notified bodies across Europe

46. Notified bodies play a key role in the regulation of medical implants, having
responsibility for approving implants for use on the EU market. UK notified bodies are
private companies, and the competence and transparency of notified bodies was
questioned. For example, Dr Heneghan stated that nobody knows the make-up of notified
bodies or their skill base, and nobody knows their [...] process of approving.134 Mr
Howlett, BSi, explained that the BSi had:
in excess of 200 assessors around the world doing medical and conformity
assessments. [...] As to our expertise, we have highly qualified reviewers from
industry and the universities where they have been involved in the design and
development of those particular products.135
Concerns appeared to focus not on the UKs notified bodies but those in other European
countries that might not perform to the same standards, thus posing a threat to patient
safety (including in the UK). The ABHI stated that currently the control and oversight by
National Competent Authorities of their Notified Bodies depends largely on voluntary and
national approaches rather than on consistent, mandatory EU level rules and standards.136
The Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians stated that
some notified bodies are not expert enough in the assessment of clinical data, of likely
safety risks in clinical use [...] to make an effective critical assessment of whether a [new]
clinical trial is needed and whether long-term safety data should be gathered in a formal
way.137 A consequence of the differences between notified bodies is that less scrupulous
manufacturers may use this to their advantage. The Royal College of Surgeons (RCS)
outlined its concerns over the current potential for variability in the standards and
131
Q 33
132
Ev w13
133
Qq 126127
134
Q5
135
Q 48
136
Ev 42, para 15
137
Ev w13
23
expertise of national Competent Authorities and the Notified Bodies to which they
delegate responsibility for approving medical devices.138 The RCS added:
This scope for variation presents the possibility that a device failing to meet the
approval criteria of one Notified Body may gain approval from another less stringent
Notified Body elsewhere. We see this as not only a public protection risk, but also a
major barrier to increasing public confidence in the system.139
The practice of getting products assessed by a notified body thought more likely to provide
a favourable opinion was referred to as forum shopping.140 The BSi wrote to the
European Commission stating that if forum shopping exists it is direct consequence of
inconsistency between Member States and Competent Authorities that leads to an
environment where Notified Bodies are not consistent.141 Mr Howlett, BSi, explained that
There is the potential for a manufacturer, faced with demands from the Notified
Body to submit more comprehensive information, particularly clinical data to
support device safety, to withdraw an application and seek another [notified body].
BSI has been aware of situations where a manufacturer had withdrawn an
application and had been successful just a few months later, clearly without any
further clinical data, to gain certification through another [notified body].142
47. He clarified that the BSi had experienced this seven times over the past five years, and
further emphasised that the instances of this nature are relatively rare but the
consequences of each individual case could be very significant in respect of patient
safety.143 Due to the lack of transparency, it was difficult for us to evaluate how common
forum shopping was beyond this anecdotal information.
48. Differences between notified bodies across Europe are a key weakness in the current
regulatory system and can result in forum shopping, whereby manufacturers choose
notified bodies more likely to provide approval for a device. Forum shopping is
facilitated by a lack of transparency and therefore accountability. Notified bodies
should consider publishing records of all approaches by manufacturers, regardless of
whether applications were completed or not.
49. The European Commission plans to address regulatory inconsistencies by moving
from Directives to Regulations.144 Ms Minor claimed that this would have the effect of
meaning that no national legislation is required to translate the rules into the legal systems
of the member states, which will eliminate to some degree differences of interpretation or
of application.145 Ms Minor explained that the revision to the Directives will include a
system where responsibility for designating a notified body remains with the competent
138
Ev w25
139
Ibid.
140
For example, Q 141 [Sir Kent Woods]
141
Recast of the Medical Devices Directive consultation, Comments from BSI UK Notified Body, BSI, ec.europa.eu
142
Ev 51
143
Ibid.
144
Q 88
145
Q 88
24
member state, but prior to that designation there would be a joint inspection by several
Member States, which would serve to reduce the discrepancies between different notified
bodies across Europe.146 This process would be overseen by a central European Medical
Devices Expert Group.147 The Commissions proposal considers that such joint
assessments would ensure effective control at Union level.148 In its written evidence the
MHRA stated that involving experts from more than one Member States in designating
notified bodies would drive a consistently high level of oversight of Notified Bodies,
ensuring that they are designated on the basis of proven competence for the devices that
they will be assessing. 149 A likely consequence of this new designation process was thought
to be a reduction in the number of notified bodies in Europe.150 However, the costs of premarket approval would increase as fees charged by notified bodies for approving medical
implants are likely to increase.151 Ms Minor stated that the industry had been consulted
regarding this proposal and that they feel this is a cost which the industry must bear [...] in
order to improve confidence in the system and restore trust.152 We asked whether the
additional cost might prohibit small companies bringing a product to market in Europe
and Ms Minor responded:
I honestly do not think so, because we are talking about a notified body, as you have
heard, which is designated for a number of years. A number of manufacturers go to
them for certificates, so when it is spread across all the certificates and all the
manufacturers, I do not think it would amount to a substantive increase.153
Sir Kent, MHRA, stated that while there will be an increased cost of doing more clinical
studies pre-market authorisation [...] we should not allow that to become so burdensome
that it shuts off the innovation process.154
50. In the proposed revision to the Directive, manufacturers of Class III devices (the
highest risk category) wishing to bring this device to the EU market will have to notify
their intention centrally.155 Ms Minor explained that:
At that point, competent authorities in all the member states would learn of
something that is approaching the point at which it will be placed on the market [...]
When that notification is made, it will be examined by our scientific experts. The
scientific opinion would go to the central committee, the medical device expert
146
Q 91
147
Q 92
148
149
Ev 35, para 33
150
Q 93
151
Q 95
152
Q 96
153
Q 97
154
Q 143
155
Q 107
25
group, and they would offer an opinion as to the [clinical] evidence [for the device]
presented, which would then go back to the notified body.156
The Commissions proposal, published in September 2012:
introduces the obligation for notified bodies to notify an expert committee [...] of
new applications for conformity assessment of high-risk devices. On scientifically
valid health grounds, the expert committee will have the power to request the
notified body to submit a preliminary assessment on which the committee can issue
comments within a deadline of 60 days, before the notified body can issue a
certificate. This scrutiny mechanism empowers the authorities to have a 'second look'
at individual assessments and make their views heard before a device is placed on the
market. A similar procedure is currently already applied for medical devices
manufactured utilising animal tissues (Commission Directive 2003/32/EC19). Its use
should be the exception rather than the rule and should follow clear and transparent
criteria.157
51. While the notion of greater coordination at European level was broadly welcomed,
there were mixed views on whether pre-market approval of medical devices should be
conducted by a centralised EU body. The Faculty of Pharmaceutical Medicine of the Royal
Colleges of Physicians considered that:
A central body approving and overseeing notified bodies may be not be readily
accepted by industry, although it would reduce inconsistency and increase fairness. It
would likely increase the demand for clinical trial data for some Class IIb and Class
III devices, which industry may see as overly onerous. However, if a new system of
approving higher risk devices increases patient safety and public confidence, this
would have long-term societal and industrial benefits.158
The ABHI, representing the industry, was in favour of the current decentralised approach
and stated:
Today the EU oversight of medical devices is decentralised and this European
approach makes it possible to manage what is a highly innovative and diverse
industrial sector in terms of products, technologies and services. The decentralised
approach is best placed to provide the capacity to efficiently deal with the many
applications related to over 400,000 products on the market from over 22,000
medical technology businesses, 80% of which are SMEs.
The decentralised approach, which is the essence of the current system, should
remain a basic principle of the future legislative framework for medical devices in
order to preserve safety, flexibility and pace. However, the current system does suffer
from disparate national approaches. It needs improved coordination at EU level to
156
Q 107
157
158
Ev w13
26
ensure uniform application by Member States, especially in the areas of Notified

Bodies and vigilance.159
52. Lord Howe, Departmental Under Secretary of State, Department of Health, also
considered that medical device manufacturers would prefer coordination between EU
Member States rather than a centralised body because they fear that a centralised
European mechanism could act as a brake on innovation and add to costs
unnecessarily.160 The Minister added we would prefer to see a model involving much
more efficient co-operation between member states.161 The MHRA explained that whilst
the idea for using the [European Medicines Agency] has since been disregarded, it seems
likely that the Commission will include a proposal for some sort of central EU scrutiny of
new class III devices in addition to assessment by a Notified Body before they are placed on
the market.162 The MHRAs principal concerns were that this would result in duplication
of the work of notified bodies and that it is unclear to what extent a central EU resource
will be able to scrutinise this in any meaningful way, without requiring a substantial
investment in staff.163 In addition, introducing this additional step could serve to muddy
the water in relation to where responsibility lies for pre-market scrutiny, and risks reducing
the onus on a Notified Body to undertake their activities properly.164
53. We support the proposal to use teams of experts drawn from Member States to
oversee the designation of notified bodies in order to minimise differences and raise
and harmonise standards across Europe.
54. Beyond this, we do not support further centralisation of medical device regulation
in the EU, as increased bureaucracy could slow device approvals unnecessarily. The
speed of device approval is a strength of the current system. The emphasis should be on
raising the standards and accountability of notified bodies and we are opposed to premarket approval processes being transferred to or being duplicated at European level.
Therefore we do not support the European Commissions proposal to require a central
notification of intent from manufacturers seeking approval for new devices. We urge
the Government to oppose this proposal during Council negotiations.
55. Manufacturers may be charged increased fees by notified bodies if more
coordinated oversight leads to a reduction in the number of notified bodies. We are not
fully convinced by reassurances provided by the Government or Commission that this
would not hinder small companies bringing products to market. The Commission and
Government should explain how they intend to support small, innovative companies in
the medical devices sector if pre-market approval becomes prohibitively costly.
159
Ev 43-44, paras 26-27
160
Q 130
161
Qs 126 and 128
162
Ev 36, para 39
163
Ev 36, para 40
164
Ibid.
27
4 Post-market surveillance
56. The process of gathering data to monitor an implant in use is called post-market
surveillance. As indicated in the previous chapter, post-market surveillance is a crucial
element of the current regulatory system that adds to the evidence base about how well
implants work in real world conditions. The MHRA considered that improvements to
post-market surveillance were a key area that needs to be addressed in the revision of the
Directives.165
Reporting of adverse incidents

Manufacturers
57. Once an implant has been approved for the European market, the Directives require
manufacturers to undertake post-market surveillance.166 The MHRA explained that
because it is not feasible to run pre-market clinical investigations for the expected lifetime
of an implant, nor is it usually possible or appropriate to carry out randomised clinical
trials such as is done with pharmaceuticals, a critical aspect of ensuring the safety of
implants is therefore a manufacturers responsibility to ensure that adequate post-market
surveillance is in place once an implant has met the relevant requirements for CE
marking.167 John Howlett, Head of the British Standards Institute (BSi) explained that:
The medium and long-term effects [of medical implants] have to be coming from
post-market. It is unreasonable to think that we can predict 10-year performance if
we are looking at hip joints and, say, 90% success after 10 years. It is not reasonable
to think that you can do that through a clinical trial. It is a combination of test data
and doing all you can to demonstrate patient safety in the short term, and then
monitoring for any further medium to long-term effects through the post-marketing
phase.168
He stated that the essential elements of post-market surveillance are early warning
systems, gathering of data and registries.169 Mr Howlett also explained that when seeking
pre-market approval for a medical implant, manufacturers must present a robust plan of
how they will gather post-market data.170 Post-market data largely come from reports of
adverse incidents171 but notified bodies also actively take part in post-market vigilance
through auditing manufacturers and periodically reviewing product certificates.172 In the
UK, the MHRA investigates both the mandatory serious adverse event reports from
165
Ev 36, para 42
166
Ibid.
167
Ev 33, para 16
168
Q 49
169
Q 49
170
Q 71
171
Q 19
172
Q 71
28
manufacturers as well as adverse events reported voluntarily by healthcare professionals

and members of the public; thereby actively monitoring implants once they are on the
market.173
58. The MHRA considered that while the Medical Devices Directives require
manufacturers to undertake post-market surveillance this is in rather general and
imprecise terms and, as such, it is undertaken with variable rigour. 174 The Centre for
Evidence-Based Medicine and the British Medical Journal (BMJ) considered that there
were:
many vested interests that disincentivise manufacturers and clinicians from
highlighting problems as they arise [...] The extent to which manufacturers
undertake post-marketing surveillance is currently unknown. Rather than have large
post-marketing studies, manufacturers may rely simply on feedback from users.175
59. Manufacturers should publish the results of post-market surveillance studies.
60. Echoing some of the concerns set out in the previous chapter, the ABHI considered
that the key problem lay with notified bodies, that had not been designated or controlled
with sufficient rigour and that therefore this aspect of the device regulatory system must
be improved.176 Medtronic Ltd, a devices manufacturer, also considered that the
oversight of these notified bodies by Member States differs enormously again causing
consistency problems for industry.177
Clinicians and patients
61. Effective post-market surveillance requires that patients and cliniciansthe users
report problems as they arise; although this is not mandatory. Dr Suzette Woodward,
Director of Patient Safety, National Patient Safety Agency (NPSA), outlined a number of
barriers limiting effective reporting by clinicians:
There is the lack of feedback. If you report something and you hear nothing back,
you say, What was the point in me doing that?
There is the issue of immediacy. If something is going wrong, you deal with what is
going wrong. You deal with the patient, the family and the issues. By the time you
have done all that and ended your shift, you will want to go off and do not
necessarily come back and fill out an incident report. Incident reporting systems are
seen as highly bureaucratic.
Performance management systems make you end up feeling that you as a person or
your colleague are being blamed, rather than the organisation, the group or team that
173
Ev 34, para 21
174
Ev 33, para 16 and Ev 36, para 42
175
Ev w3
176
Ev 42, para 16
177
Ev w17, para 11
29
you are in saying, This has obviously gone wrong. Lets see if we can learn from it.
We need a culture of learning rather than punishment.178
She stated that to encourage clinicians and healthcare professionals to report faults more
often, we need to make it feel worthwhile, give them lots of feedback, make it a learning
system and make them feel supported when things have gone wrong.179 Carol Holland,
Altogether Hip Support, stated that:
Surgeons should have a legal obligation to notify the Joint Registry of exactly what
joints are being fitted and of any problems reported. Then those joints with more
problems would be flagged earlier. It seems, at present, surgeons are loathe to admit
problems in case it appears to make them look incompetent.180
62. The Royal College of Surgeons also considered that there is great potential for
surgeons to fulfil a mandatory implant monitoring duty through audit and procedure
registries, adding there is evidence to suggest that where audits and registries are well
established, it is possible to identify problems with specific implants and devices as well as
assess clinical outcomes and surgical performance more broadly.181 The British Standards
Institute (BSi) agreed that reporting by healthcare professionals should be mandatory to
ensure that all reports are made available to the appropriate medical device manufacturers
so that manufacturers can fulfil their vigilance reporting and incident investigation
obligations.182 Registries are further explored from paragraph 68.
63. The MHRA has an online reporting system for reporting adverse incidents with
medical devices.183 Dr Thomas Joyce and Dr Pauline McCormack from Newcastle
University stated that we have repeated reports from patients that their concerns over
symptoms from their hip implants were dismissed and/or ignored by medical
professionals.184 They considered that the Yellow Card System should include users of
medical devices.185 The Yellow Card Scheme is the main adverse drug reaction reporting
scheme in the UK. It is intended to help the MHRA monitor the safety of the medicines
and vaccines that are on the market and provides a way for patients and healthcare
providers to report side effects of medicines to the MHRA.186 Sir Kent stated that the
MHRA had taken action to make it easier to report adverse incidents related to medical
devices; it had created an IT system that makes it easier for manufacturers to deliver [...]
reports to the MHRA, and in the middle of the MHRA website there is a button about
medical device adverse incident reports which can be used by clinicians and patients alike:
178
Q 19
179
Q 19
180
Ev w9, para 3
181
Ev w25
182
Ev 50
183
Reporting adverse incidents involving medical devices, MHRA, www.mhra.gov,uk
184
Ev 46
185
Ibid.
186
Yellow Card, MHRA, yellowcard.mhra.gov.uk
30
the incident report is sent directly to the MHRA database for analysis.187 He also stated that
the MHRA has electronic yellow card reporting now, too for devices.188
64. The MHRA uses a Black Triangle Scheme to monitor newly licensed medicines that
have been approved for use on limited clinical data.189 Such medicines are marked with a
black triangle symbol to indicate to healthcare professionals that their side-effects and
associated adverse incidents should be closely monitored and reported to the MHRA.190
Nuffield Health, a UK health charity, considered that fundamental lessons learnt from
medicine regulation had not been transferred to implantable medical device regulation
and that the Black Triangle status sends a clear signal to healthcare professionals that a
particular product requires an intense level of reporting.191 The Independent Healthcare
Advisory Services (IHAS) recommended that an analogy to the Black Triangle process for
medicines should be adopted.192
65. Although web-based reporting has the advantage of being able to reach across both
hospital and community settings, Dr Armitage, University of Bradford, considered that
patients have specific concerns about web based reporting.193 The reasons for this
included:
The need to maintain confidentiality; the requirement for a quick and personalised
response; a coding mechanism which can triage the patients concerns; an option to
report positive as well as negative comments; and that a relative can report on behalf
of a patient (who is officially nominated by that patient). 194
66. We are satisfied that the mechanisms exist to enable patients to report adverse
incidents directly to the MHRA online if desired. In practice, patients are more likely to
approach healthcare professionals in the first instance and this places a duty on
healthcare professionals to report incidents of suspected device failure or side effects to
the MHRA. However, there is evidence of under-reporting by healthcare professionals.
To incentivise reporting, the Government should consider making the reporting of
adverse incidents by healthcare professionals compulsory. This should generate more
evidence on the risks associated with devices, which would ultimately benefit patients.
67. For medical implants (Class IIb or III medical devices) where equivalence data has
been used in place of clinical trials or evaluations of the specific implant, the Black
Triangle Scheme (or an equivalent system) should be adopted in the UK. This would
mean that devices approved on equivalence alone would be subject to stronger postmarket monitoring.
187
Q 147
188
Q 147
189
Black Triangle Scheme, MHRA, www.mhra.gov.uk
190
Medicines & Medical Devices Regulation: What you need to know, MHRA, www.mhra.gov.uk
191
Ev w18
192
Ev w29
193
Ev w35, para 6
194
Ibid.
31
Registries
68. The National Joint Registry (NJR) for England and Wales was established by the
Department of Health and the Welsh Assembly Government in 2002 to collect data on all
hip, knee, ankle, elbow and shoulder joint replacements across the NHS and independent
healthcare sector.195 It is mandatory for clinicians to report information to the NJR.196
Sir Kent stated:
The National Joint Registry is the biggest in the world now. It has over a million hip,
knee and ankle replacements in its register, and it produces an annual report, which
sets out in very great detail the follow-up results of those procedures by type of
operation, type of device and manufacturer of device. That is a valuable resource for
changing clinical practice. That is the way in which accumulating information on
outcome is fed back to improving care and, therefore, improving outcomes.197
In August 2010 DePuy had to issue a worldwide recall of their ASR hip resurfacing implant
because data from the NJR showed that more people than anticipated had experienced
problems and required a second hip replacement surgery.198 This demonstrated that
implant registries can be a powerful contributor to effective post-market surveillance.199
69. The NJR covers joint replacements. Professor Murray explained that while there are
currently no requirements for other implants to be registered, some professional bodies
have developed their own databases and voluntary recording systems.200 Registries do not
always succeed: the MHRA funded a National Breast Implant Registry between 1993 and
2006,201 which failed because the completeness of registration was totally inadequate, and,
secondly, the willingness of patients [...] to give follow-up information was far too low to
allow conclusions to be drawn.202 Nevertheless, the Health Committee recommended in
their recent report on PIP breast implants that registry of all implants should be
compulsory.203
70. Although Sir Kent stated that the transparency that now exists around the outcomes of
joint replacement surgery through the National Joint Registry is a model of what might be
achieved in other areas were there to be better follow-up data presented in a more coherent
and consistent way,204 there have been calls for greater transparency even with the NJR.
Dr Thomas Joyce and Dr Pauline McCormack from Newcastle University suggested that
we should consider whether the raw data contained in [the NJR] could be made more
195
About the NJR, National Joint Registry, www.njrcentre.org.uk
196
Q 78
197
Q 134
198
ASR hip replacement recall media guide, DePuy, www.depuy.com
199
Q 18, Q 146
200
Ev w10
201
202
Q 146 [Sir Kent Woods]
203
204
Q 134
32
readily available.205 They also pointed out the value of keeping explanted joints (implanted
joints that have been subsequently removed):
Examination of explanted joints that have failed or caused problems in the body is
one of the most valuable sources of data about how and why implants failthey can
be thought of as the black box. Revision operations, which remove such problem
implants have to be reported to the National Joint Registry (NJR) but conservation of
the failed joint itself is not required and many are simply thrown away [...] We call
for the conservation and analysis of explanted joints to be made mandatory as part of
the NJR reporting procedure.206
71. The Government should ensure that raw data from the National Joint Registry
(NJR) is published where possible. In addition, explanted joints should be analysed,
and subsequent data generated should be reported to the NJR and published.
EU registry
72. Ms Minor from the European Commission informed us that the revisions to the
Directive included plans for developing the European databank on medical devices
(Eudamed) into an EU-wide medical devices registry. Ms Minor explained that this would
serve to increase access to and transparency of clinical data, as well as improve post-market
surveillance:
We are planning to have a central registry in which all manufacturers and all devices
will have to be listed. For each device, there will be some standard information, such
as the name of the notified bodies, the class of risk, and the unique device identifier,
when we have that. There will also be a summary of performance and clinical data.
For the first time, for example, clinicians will be able to have access to the clinical
data which supported the certificate granted to the device.207
This registry would cover all medical devices (that is, Classes I to III), and would therefore
include thousands of items.208 There would also be a fee for manufacturers associated with
it, but Ms Minor pointed out that currently manufacturers are faced with the possibility of
having to register 27 times, because a number of member states have set up registries209 so
a central registry should ideally reduce both overall cost and bureaucratic burden
associated with registries across the EU.210
73. According to the National Institute of Health and Clinical Excellence (NICE), it is
difficult to set up new registers.211 The Minister stated that the England and Wales NJR is
expensive to maintain and costs about 3 million a year.212 He compared this with the
205
Ev 46
206
Ibid.
207
Q 109
208
Q 112
209
Q 114
210
Q 115
211
Ev w34
212
Q 146
33
10 million spent on the whole of the MHRAs devices-related work.213 Ms Minor

explained that the start-up and maintenance costs of the proposed EU registry would be
covered by the European Commission, and that the registry would be available when the
new regulatory framework goes live which would be towards the end of 2014-15.214
74. Ms Minor also explained that the proposed changes to the Eudamed database would
include an EU portal for reporting faults, so that every serious incident would be reported
directly at European level.215 She stated:
I hope that would enable us to pick up more quickly any emerging trend that gave
concern in relation to a device. We also hope to make some funds available to have
some central trend analysis, so that we would have scientists working in our joint
research centre looking at the data coming in and being able to check it and sound
the alarm more quickly than has been the case in the past. 216
75. This portal will be designed for manufacturers to report faults, but the European
Commission is looking to include provisions for healthcare professionals and patients to
use it as well.217 Ms Minor also considered that reporting faults should be mandatory for
healthcare professionals.218 Lord Howe was supportive of greater coordination of
communication between EU Member States, but stated:
If we can get greater sharing of data between member states, maybe even have an EU
portal where data can be fed in when there is an adverse report on a device so that it
is clearly on view to all member states, that would be much more efficient and
effective and much less cumbersome [than establishing an EU body overseeing these
functions].219
76. The MHRA had been pushing the Commission to require registration of all devices
placed on the EU market [...] on a central EU portal (currently the responsibility of
member states) and the development [of] an effective and efficient electronic
communication and information support tool to support co-ordinated post-market
surveillance across the EU.220 Improving co-ordination, both within the EU and globally
is an aspect of the Commissions joint plan for immediate action and will also feature in
the revision of the Medical Devices Directives.221
77. An additional proposal is that each device would be marked with a Unique Device
Identification (UDI), which, according to the ABHI, would:
213
Q 146
214
Q 100; Ev 48, para 4; Q 85
215
Q 98
216
Q 98
217
Q 106
218
Q 105
219
Q 128
220
Ev 37, paras 4950
221
Ibid.
34
enable a particular implant to be linked to the patient who receives it and will greatly
assist in the setting up of databases and registries. UDI will be based on
internationally accepted standards and will eventually become a global requirement
for devices as it is also the subject of legislation in North America, Australia and
other regions.222
78. For Sir Kent the key issue was to make sure that the data are captured at the time the
procedure is done.223 He agreed that the key to that would be to have a unique device
identifier so that there is a recognised code that describes a device. That is something that is
very much in the Commissions thinking for the revision of the directives.224 The
Commissions September 2012 proposal includes:
a requirement that manufacturers fit their devices with a Unique Device
Identification (UDI) which allows traceability. The UDI system will be implemented
gradually and proportionate to the risk class of the devices; [and]
a requirement that manufacturers/authorised representatives and importers must
register themselves and the devices they place on the EU market in a central
European database.225
79. The National Joint Registry (NJR) proved useful in identifying high revision rates of
metal-on-metal hip implants and should serve as the gold standard for implant
registries. Part of its success is due to contributions from clinicians being mandatory.
As such, we welcome the Commissions proposal that manufacturers, authorised
representatives and importers must register themselves and devices placed on the EU
market on a central European database.
80. We support the European Commissions plans to expand Eudamed to include an
EU registry of medical devices in classes IIa, IIb and III, but we would not advocate
Eudamed replacing the National Joint Registry in England and Wales in the foreseeable
future. The Government must ensure that the proposed Eudamed registry achieves or
exceeds the successes of the NJR before any replacement of the NJR is considered. These
successes include, but are not limited to, the breadth of clinical data collected, the ease
of reporting incidents by clinicians, and access to the data by clinicians and researchers
for analysis.
81. We recommend that the inclusion of data from explanted medical implants should
be a requirement of the Eudamed registry.

82. The MHRAs role, as the UKs competent authority, is to monitor and investigate
adverse events and field safety corrective actions (including recalls) occurring in the UK.226
222
Ev 43, para 25
223
Q 146
224
Q 146
225
226
Ev 32, para 9
35
It is also responsible for recalling faulty products and offering advice to the health service,
primarily through Medical Device Alerts, but also through safety pamphlets, posters, and
bulletins.227
83. There were mixed views on the MHRAs speed of response to reports of faulty medical
implants. Professor Stephen Westaby, Consultant Cardiac Surgeon, John Radcliffe
Hospital, Oxford, was impressed with the MHRAs response to a concern he raised about a
heart valve:
I am very positive about MHRA and how it works. I took a concern to it about [a]
particular heart valve [...] Its response was very prompt and effective; it did a very
good job in preventing the sort of scandal, which would have been completely
inappropriate, that we saw in the PIP implants.228
On the other hand, some criticised the MHRA for being slow to respond to incident
reports. For example, an article in the British Medical Journal (BMJ) reported that
problems with the now-recalled DePuy ASR metal-on-metal hip implant systems were first
noticed by the Australian National Joint Replacement Registry in 2007.229 These hip
implants were removed from the Australian market in December 2009, but the worldwide
recall was not issued until August 2010, following analysis of data from the National Joint
Registry of England and Wales.230 The BSi, a UK notified body, certified these hip implants
for the EU market. Sheila Sunley, member of the Altogether Hip Patient Support Group,
considered that the MHRA should have responded more quickly than it did to the
concerns raised in Australia.231 Dr Heneghan and the BMJ considered that the failure in
some cases to evaluate rapidly devices in which concerns have been expressed seems quite
unacceptable. Doctors have said that the MHRA is slow to respond when they do raise
concerns.232 We asked some of our witnesses whether the recall of metal-on-metal hip
implants represented a success or failure of the regulatory system. Dr Joyce, Newcastle
University, stated it is a failure. We speak to many thousands of people, and these lives
have been absolutely ruined.233 Dr Woodward, NPSA, suggested:
If you take the aviation industry as the gold standard and places such as Toyota, they
have a system whereby, if something goes wrong with one airline or even one flight,
it is known throughout the system within about 12 hours. That is what we need for
the NHSa system whereby, if you pick up really quickly that something is going
wrong, rather than wait for months and months, you need to be able to spread it
around really quickly [...] What we would want to happen when somebody picks up
227
Ev 34, para 21
228
Q5
229
Out of joint: the story of the ASR, British Medical Journal, 15 May 2011, www.bmj.com
230
Recall of DePuy Orthopaedics ASR hip replacement device, Australian Government Department of Health and
Ageing, 16 May 2011, www.tga.gov.au
231
Ev w3, para 2
232
Ev w3, para 4
233
Q 18
36
that things are going wrong is that you stop any future surgery or implanting or
whatever, until you know that it is safe to start again.234
84. Sir Kent Woods, MHRA, explained that competent authorities have an obligation to
notify [other] competent authorities if they hear of serious adverse incidents that might
affect products on the market in the other countries of Europe.235 He stated:
I do not think in practice [that communication] is as regular and detailed as it could
be. One of the aspects of the legislative review has been how to improve the
interaction between the national competent authorities across the 27 member states.
As you might expect, some of the national competent authorities are larger; they
have better resources and more data, but we are dealing in a European system and it
is important that we draw on experience from the whole population of 500 million
and share our resources. We have been exploring among ourselves as heads of the
national competent authorities how best to do this. 236
The Minister did not express concerns over the MHRAs response to the problems with
metal-on-metal hip implants and in fact considered it to be probably a good news story,
as in this country we were able to react very swiftly with the medical community to
influence clinical practice when concerns became apparent.237 Ms Minor explained that
the revisions to the Directive included centralising the risk analysis of reported faults. The
aim was to implement a unified approach amongst Member States in response to largescale incidents with medical implants, such that a common European recommendation as
to how it should be addressed can be made.238
85. We are satisfied that the Commission intends to propose greater coordination
across EU Member States when adverse incidents are reported. However, global
coordination and collaboration are also essential. It is disappointing that problems
with metal-on-metal hip implants were picked up several years before the worldwide
recall and it appears that the MHRA was slow in responding to data emerging from
Australia. Because of that delay, many patients have suffered needlessly. The Ministers
view that the MHRAs response to the problems with metal-on-metal hip implants was
a good news story shows some complacency. The European Commission and UK
Government must improve the speed with which information from adverse incident
reporting abroad is handled and acted upon.
86. As discussed in paragraph 25, notified bodies audit manufacturers prior to certifying
new medical implants for the EU market: this includes assessing manufacturers facilities
and technical documents. Auditing continues after market approval: the MHRA explained
234
Q 18
235
Q 136
236
Q 136
237
Q 148
238
Q 103
37
that these assessments normally take place annually to ensure ongoing compliance with
the requirements of the legislation.239 Mr Howlett, BSi, explained that:
When we are looking at situations where a manufacturer is found wanting, the first
line of approach as a notified body is to bring that manufacturer into compliance.
We do not want to be denying the patient the product; we want that product, if it is a
good one, to be brought to the market in a safe condition. We would work with them
and agree corrective action plans.240
87. The recent withdrawal of PIP breast implants highlighted the need to conduct regular
inspections of manufacturers facilities. PIP breast implants were certified for the EU
market in 2000 by the German notified body TUV Rheinland.241 The interim report by
Bruce Keogh, NHS Medical Director, noted that concerns began to emerge among
cosmetic surgeons about the performance of PIP implants from 2006.242 However, it was
not until the French competent authority conducted an inspection of the PIP
manufacturing facilities in March 2010 that it was discovered that the manufacturer was
using an unapproved implant filler.243 The MHRA had raised concerns with the PIP
manufacturers several times between 2006 and 2010. 244 The Minister stated that it was
clear from my investigation that no amount of regulation could have prevented deliberate
fraud of that kind.245 Professor Westaby agreed that it was a fraudulence issue and that
If the regulatory authorities are told that a certain content is present in a device, they are
justified in taking that as accepted.246
88. Nevertheless, there was a desire to improve the auditing process. The Independent
Healthcare Advisory Services (IHAS) suggested that:
Increasing the frequency and depth of inspections carried out at both the legal
manufacturer and the actual producers sites would naturally lead to a raise in
standards across the medical device industry. Options include more frequent
unannounced inspections, more detailed audits and tougher sanctions.247
89. The Harley Medical Group stated that the testing that currently takes place after
commercialisation is not adequate [...] The visits to the manufacturer must be
unannounced and must take place several times a year.248 The MHRA stated that the
European Commission aims to improve the audits carried out by notified bodies, with a
239
Ev 33, para 13
240
Q 56
241
Health Committee, Sixteenth Report of Session 2010-12, PIP Breast implants and regulation of cosmetic
242
Poly Implant Prothses (PIP) Breast Implants: Interim Report of the Expert Group, Department of Health, 6 January
2012, p6
243
Poly Implant Prothse (PIP) silicone breast implants: Review of the actions of the Medicines and Healthcare
products Regulatory Agency (MHRA) and Department of Health, Department of Health, 14 May 2010, p87
244
Poly Implant Prothse (PIP) silicone breast implants: Review of the actions of the Medicines and Healthcare
products Regulatory Agency (MHRA) and Department of Health, Department of Health, 14 May 2010, p7287
245
Q 148
246
Q3
247
Ev w27, para 3.7
248
Ev w 3, para 2
38
particular focus on ensuring that Notified Bodies undertake unannounced inspections of

manufacturers.249 The Minister stated:
There is also a case for specifying in greater detail how notified bodies should
undertake conformity assessments and ongoing monitoring of manufacturers, and
the use of unannounced inspections and audits, perhaps requiring physical checks of
devices. I know this takes us into the territory of greater prescription, but perhaps
there is a case for looking at that more closely if we really want to see greater
consistency of performance across Europe.250
The Commission has proposed that:
the position of notified bodies vis--vis manufacturers will be significantly
strengthened, including their right and duty to carry out unannounced factory
inspections and to conduct physical or laboratory tests on devices. The proposal also
requires rotation of the notified body's personnel involved in the assessment of
medical devices at appropriate intervals to strike a reasonable balance between the
knowledge and experience required to carry out thorough assessments and the need
to ensure continuous objectivity and neutrality in relation to the manufacturer
subject to those assessments.251
90. We are supportive of proposals to enforce unannounced audits of manufacturers by
notified bodies, and recommend that in addition, audits should take place at least
annually. Frequent and unannounced auditing of manufacturers by notified bodies
should be enforced by competent authorities.
91. Although we have not received evidence to suggest that notified bodies face a
conflict of interest in auditing manufacturers whose devices they have approved, it may
be a risk. We welcome the proposal to rotate notified bodies personnel to increase
objectivity and neutrality, but we suggest that audits of a manufacturer by a notified
body that did not approve that manufacturers devices should also take place.
249
Ev 35, para 35
250
Q 141
251
39
5 Conclusions
The MHRA
92. Although much responsibility for medical implant regulation is delegated to notified
bodies and manufacturers, the MHRA plays a key role in the UK. We heard mixed views
on the MHRAs overall performance in medical devices regulation. For example,
Medtronic Ltd, a manufacturer of medical devices, stated that compared to some other
national Competent Authorities, MHRA is well-resourced, has technically competent staff,
and maintains vigilant oversight of clinical trials conducted in the UK, post market
surveillance and Notified Bodies it designates.252 The Association of British Healthcare
Industries also considered that the MHRA does a very effective job in implementing the
Directives and that it was often considered to be the pre-eminent Device authority in the
EU and is well respected throughout Europe and beyond among those concerned with
efforts to achieve global harmonization in device regulation.253 However, Dr Stephen
OConnor from the Institute of Physics and Engineering in Medicine (IPEM) considered
that the MHRA was overly bureaucratic relative to other competent authorities in the EU,
inefficient and difficult to deal with.254 We also heard from a number of patients from the
Altogether Hip Patient Support Group, who considered that MHRA did not prioritise
patient wellbeing. This patient-led group was established in February 2011 for patients
fitted with DePuy ASR metal-on-metal hip implants, as a source of information and
support.255 Members of this patient group stated that the MHRA seems to be a totally
ineffective body working on behalf of the corporations rather than patients256 and that
the MHRA is a toothless organisation influenced by manufacturers not patient care.257 In
a recent editorial, the medical journal The Lancet stated that the failure of PIP breast
implants and metal-on-metal hip implants resulted from MHRA's paralysis and inability
to address the shortcomings of a badly flawed system and that there is an urgent need for
reform of the MHRA.258
93. The lack of transparency of the MHRAs operations was also heavily criticised. The
MHRA has a Committee on the Safety of Devices (CSD), which is a group of 25 external
experts from clinical and scientific disciplines.259 The CSD was established in 2001 and
meets two to three times a year.260 It supports the Devices sector of the MHRA in its aim to
protect public health and safeguard the interest of patients and users.261 It achieves this by
ensuring that medical devices and equipment meet appropriate standards of safety,
252
Ev w16, para 6
253
Ev 42, para 12
254
Ev w1
255
Altogether ASR Hip Support Group, Altogether ASR Hip Support Group, www.altogetherasr.co.uk
256
Ev w9, para 2
257
Ev w3, para 2
258
Stricter devie regulation needed: lessons from the past, The Lancet, Volume 379, Issue 9835, Page 2402, 30 June
2012
259
Q 132
260
Committee on the Safety of Devices, MHRA, www.mhra.gov.uk
261
40
quality and performance and that they comply with relevant Directives of the European
Union.262 Nuffield Health pointed out that the CSD can make recommendations
however, since the committee does not make decisions, it is not subject to independent
review or audit.263 The MHRA website states that the work of the Committee must
remain confidential at all times. There could be serious consequences to industry if any
leaks occurred from committee meetings.264 We asked Sir Kent Woods about this and he
explained that this lack of transparency was due to obligations of confidentiality placed on
the MHRA by the Medical Devices Directives (MDD), but that he would like to see this
changed.265 The MDD states that:
Without prejudice to the existing national provisions and practices on medical
secrets, Member States shall ensure that all the parties involved in the application of
this Directive are bound to observe confidentiality with regard to all information
obtained in carrying out their tasks. This does not affect the obligation of Member
States and notified bodies with regard to mutual information and the dissemination
of warnings, nor the obligations of the persons concerned to provide information
under criminal law.266
94. Any revision to the Directives should include removing the over-emphasis on
confidentiality. The default should be transparency and openness, unless there is a
compelling reason otherwise. Perceptions of secrecy can be, and have been, very
damaging to public trust in the regulatory system. Transparency also enables more
effective external scrutiny of the system and the parties involved.
95. It is impossible to evaluate the performance of the MHRAs Committee on the
Safety of Devices (CSD) when its work is kept secret. We recommend that the MHRA
improves the transparency of the CSD, for example by publishing the minutes of its
meetings as well as the advice it provides.
The regulation of medical implants

96. Effective regulation of medical implants is paramount to patient safety in the UK and
EU. Patients and healthcare providers alike should feel confident that medical implants
available for use in the EU conform to a high standard of safety and quality, while still
granting patients access to the latest innovations. One of the key questions is whether the
PIP breast implant and metal-on-metal hip implant recalls have been exceptional, albeit
unfortunate, incidents, or whether they represent deeper weaknesses in the regulatory
system. The MHRA stated that:
Issues with PIP silicone breast implants and metal-on-metal hips stem from very
different root causesthe first from deliberate subversion of the regulatory system
and the second from unanticipated wear over a long time-period. However, this
262
263
Ev w23
264
265
Q 133
266
Article 20, Council Directive 93/42/EEC
41
illustrates that picking isolated examples and attributing them to regulatory failure
should not be the basis on which to advocate widespread changes to a system.267
97. We accept that the PIP breast implant case stemmed from deliberate fraud that would
have been extremely difficult to prevent. In addition, we are aware that thousands of
implants are used by patients every day, mostly without problem. We have not advocated
widespread changes to the regulatory system other than significantly increasing
transparency. However in practice there are several areas of weakness. We are pleased
that the Commissions proposed revisions to the Medical Devices Directive generally
aim to address the weaknesses we identified in the regulation of medical devices,
although we do not support all of the proposed measures.
98. It would not be possible to detect all possible adverse consequences in pre-market
assessment and therefore there is an emphasis on post market surveillance of medical
implants. However, we were unimpressed with the extent to which reliance on
equivalence data, rather than on more rigorous sources of evidence such as clinical
trials, seemed acceptable in pre-market assessment. The utility of post-market
surveillance should not detract from the priority of ensuring implants are safe and
effective before they are used in patients.
99. During this inquiry we have been disappointed with the lack of transparency and
accountability of the regulatory process and the organisations involved. Our strongest
recommendations are to increase transparency and accountability across the entire
regulatory framework and to improve the coordination and communication between
Member States. We have welcomed many of the proposed changes to the Directives,
although we caution against excessive European centralisation.
100. The EU regulatory framework for medical devices was developed with the desire to
create a free market, and the emphasis on public health followed. We consider that
safeguarding public health should be the primary aim of the regulatory system.
101. When negotiating on the proposed revisions, the UK Government should use this
Report to press for greater transparency and a more evidence-based approach to the
regulation of medical devices, particularly implants.
267
Ev 38, para 55
42
Conclusions and recommendations

1.
Although they told us that their views would be adequately represented by the
Association of British Healthcare Industries (ABHI), we are very disappointed that
we were not able to take oral evidence directly from manufacturers. (Paragraph 5)
Pre-market approval
2.
Ideally, all medical implants approved for use on the EU market would be subject to
rigorous clinical investigations prior to introduction but it is not practical to do this
for every implant and there are circumstances where reliance on equivalence data
may be acceptable. Nonetheless, it appears that the existing regulatory framework
may have the effect of encouraging manufacturers to rely on equivalence data rather
than evidence from clinical trials. This is compounded by the difficulties of
conducting clinical trials in the UK. We do not advocate a pharmaceutical style
approach to regulation. We endorse the approaches already being taken: (i) the
proposed revisions to the Medical Devices Directive make clearer when equivalence
data is or isnt acceptable and strengthen scrutiny and challenge of manufacturers
decisions; and (ii) the environment for clinical trials should be improved, not just in
the UK but across Europe. (Paragraph 34)
3.
We welcome the European Commissions proposal to make scientific advice

available to manufacturers and notified bodies when placing new implants on the
market. (Paragraph 35)
4.
The establishment of the Health Research Authority (HRA) is a welcome step

towards improving the regulation and governance of health research. We expect the
HRA to tackle the difficulties of setting up clinical trials in the UK. We intend to
scrutinise the HRA and its work and we recommend that the Government publishes
an update on the progress of the HRA in improving the environment for clinical
trials in December 2012, a year after its establishment. (Paragraph 36)
5.
Transparency should be the default position in the approval of medical implants: it is

particularly important where some of the key players influencing public health
manufacturers and notified bodiesare private organisations not accountable to
Parliament or subject to Freedom of Information requests. Greater transparency
would improve public confidence in the system and support decision-making by
patients and healthcare professionals. We are disappointed that there is a lack of
transparency in the current regulatory system and we urge the UK Government to
take a lead in increasing transparency. (Paragraph 40)
6.
The Commissions proposals are a step in the right direction, but do not go far
enough. All clinical data used in the approval of a medical implant should be made
publicly available without identifying patients or clinical trial participants. For
products currently on the market, data should be published immediately. It should
be clear when medical implants have been approved using equivalence data and
43
when clinical investigations have been conducted on that implant prior to market
approval. (Paragraph 41)
7.
In addition, regardless of whether an implant is approved for use or not, any new
clinical data generated about that implant should be published. It is as scientifically
useful to know what doesnt work as it is to know what does work. (Paragraph 42)

8.
There is insufficient evidence that the Food and Drugs Administrations (FDA) more
onerous procedures for granting market approval to medical implants have resulted
in greater patient safety. The FDA system also operates more slowly and thus delays
patient access to medical implants, which is, in itself, a threat to patient safety.
(Paragraph 45)
Notified bodies
9.
Differences between notified bodies across Europe are a key weakness in the current
regulatory system and can result in forum shopping, whereby manufacturers
choose notified bodies more likely to provide approval for a device. Forum shopping
is facilitated by a lack of transparency and therefore accountability. Notified bodies
should consider publishing records of all approaches by manufacturers, regardless of
whether applications were completed or not. (Paragraph 48)
10.
We support the proposal to use teams of experts drawn from Member States to
oversee the designation of notified bodies in order to minimise differences and raise
and harmonise standards across Europe. (Paragraph 53)
11.
Beyond this, we do not support further centralisation of medical device regulation in

the EU, as increased bureaucracy could slow device approvals unnecessarily. The
speed of device approval is a strength of the current system. The emphasis should be
on raising the standards and accountability of notified bodies and we are opposed to
pre-market approval processes being transferred to or being duplicated at European
level. Therefore we do not support the European Commissions proposal to require a
central notification of intent from manufacturers seeking approval for new devices.
We urge the Government to oppose this proposal during Council negotiations.
(Paragraph 54)
12.
Manufacturers may be charged increased fees by notified bodies if more coordinated

oversight leads to a reduction in the number of notified bodies. We are not fully
convinced by reassurances provided by the Government or Commission that this
would not hinder small companies bringing products to market. The Commission
and Government should explain how they intend to support small, innovative
companies in the medical devices sector if pre-market approval becomes
prohibitively costly. (Paragraph 55)
44
Post-market surveillance
13.
Manufacturers should publish the results of post-market surveillance studies.

(Paragraph 59)
14.
We are satisfied that the mechanisms exist to enable patients to report adverse
incidents directly to the MHRA online if desired. In practice, patients are more likely
to approach healthcare professionals in the first instance and this places a duty on
healthcare professionals to report incidents of suspected device failure or side effects
to the MHRA. However, there is evidence of under-reporting by healthcare
professionals. To incentivise reporting, the Government should consider making the
reporting of adverse incidents by healthcare professionals compulsory. This should
generate more evidence on the risks associated with devices, which would ultimately
benefit patients. (Paragraph 66)
15.
For medical implants (Class IIb or III medical devices) where equivalence data has
been used in place of clinical trials or evaluations of the specific implant, the Black
Triangle Scheme (or an equivalent system) should be adopted in the UK. This would
mean that devices approved on equivalence alone would be subject to stronger postmarket monitoring. (Paragraph 67)
Registries
16.
The Government should ensure that raw data from the National Joint Registry (NJR)
is published where possible. In addition, explanted joints should be analysed, and
subsequent data generated should be reported to the NJR and published. (Paragraph
71)
17.
The National Joint Registry (NJR) proved useful in identifying high revision rates of
metal-on-metal hip implants and should serve as the gold standard for implant
registries. Part of its success is due to contributions from clinicians being mandatory.
As such, we welcome the Commissions proposal that manufacturers, authorised
representatives and importers must register themselves and devices placed on the EU
market on a central European database. (Paragraph 79)
18.
We support the European Commissions plans to expand Eudamed to include an EU

registry of medical devices in classes IIa, IIb and III, but we would not advocate
Eudamed replacing the National Joint Registry in England and Wales in the
foreseeable future. The Government must ensure that the proposed Eudamed
registry achieves or exceeds the successes of the NJR before any replacement of the
NJR is considered. These successes include, but are not limited to, the breadth of
clinical data collected, the ease of reporting incidents by clinicians, and access to the
data by clinicians and researchers for analysis. (Paragraph 80)
19.
We recommend that the inclusion of data from explanted medical implants should
be a requirement of the Eudamed registry. (Paragraph 81)
45

20.
We are satisfied that the Commission intends to propose greater coordination across
EU Member States when adverse incidents are reported. However, global
coordination and collaboration are also essential. It is disappointing that problems
with metal-on-metal hip implants were picked up several years before the worldwide
recall and it appears that the MHRA was slow in responding to data emerging from
Australia. Because of that delay, many patients have suffered needlessly. The
Ministers view that the MHRAs response to the problems with metal-on-metal hip
implants was a good news story shows some complacency. The European
Commission and UK Government must improve the speed with which information
from adverse incident reporting abroad is handled and acted upon. (Paragraph 85)
21.
We are supportive of proposals to enforce unannounced audits of manufacturers by

notified bodies, and recommend that in addition, audits should take place at least
annually. Frequent and unannounced auditing of manufacturers by notified bodies
should be enforced by competent authorities. (Paragraph 90)
22.
Although we have not received evidence to suggest that notified bodies face a conflict
of interest in auditing manufacturers whose devices they have approved, it may be a
risk. We welcome the proposal to rotate notified bodies personnel to increase
objectivity and neutrality, but we suggest that audits of a manufacturer by a notified
body that did not approve that manufacturers devices should also take place.
(Paragraph 91)
Conclusions
23.
Any revision to the Directives should include removing the over-emphasis on

confidentiality. The default should be transparency and openness, unless there is a
compelling reason otherwise. Perceptions of secrecy can be, and have been, very
damaging to public trust in the regulatory system. Transparency also enables more
effective external scrutiny of the system and the parties involved. (Paragraph 94)
24.
It is impossible to evaluate the performance of the MHRAs Committee on the Safety

of Devices (CSD) when its work is kept secret. We recommend that the MHRA
improves the transparency of the CSD, for example by publishing the minutes of its
meetings as well as the advice it provides. (Paragraph 95)
25.
We have not advocated widespread changes to the regulatory system other than
significantly increasing transparency. However in practice there are several areas of
weakness. We are pleased that the Commissions proposed revisions to the Medical
Devices Directive generally aim to address the weaknesses we identified in the
regulation of medical devices, although we do not support all of the proposed
measures. (Paragraph 97)
26.
It would not be possible to detect all possible adverse consequences in pre-market

assessment and therefore there is an emphasis on post market surveillance of medical
46
implants. However, we were unimpressed with the extent to which reliance on

equivalence data, rather than on more rigorous sources of evidence such as clinical
trials, seemed acceptable in pre-market assessment. The utility of post-market
surveillance should not detract from the priority of ensuring implants are safe and
effective before they are used in patients. (Paragraph 98)
27.
During this inquiry we have been disappointed with the lack of transparency and
accountability of the regulatory process and the organisations involved. Our
strongest recommendations are to increase transparency and accountability across
the entire regulatory framework and to improve the coordination and
communication between Member States. We have welcomed many of the proposed
changes to the Directives, although we caution against excessive European
centralisation. (Paragraph 99)
28.
The EU regulatory framework for medical devices was developed with the desire to
create a free market, and the emphasis on public health followed. We consider that
safeguarding public health should be the primary aim of the regulatory system.
(Paragraph 100)
29.
When negotiating on the proposed revisions, the UK Government should use this
Report to press for greater transparency and a more evidence-based approach to the
regulation of medical devices, particularly implants. (Paragraph 101)
47
Formal Minutes
Wednesday 17 October 2012
Members present:
Andrew Miller, in the Chair
Stephen Metcalfe
Stephen Moseley
Sarah Newton
Graham Stringer
Draft Report (Regulation of medical implants in the EU and UK), proposed by the Chair, brought up and read.
Ordered, That the draft Report be read a second time, paragraph by paragraph.
Paragraphs 1 to 101 read and agreed to.
Summary agreed to.
Resolved, That the Report be the Fifth Report of the Committee to the House.
Ordered, That the Chair make the Report to the House.
Ordered, That embargoed copies of the Report be made available, in accordance with the provisions of
Standing Order No. 134.
Written evidence was ordered to be reported to the House for printing with the Report.
[Adjourned till Wednesday 24 October at 9.00 am
48
Witnesses
Wednesday 23 May 2012
Page
Dr Carl Heneghan, GP and Reader in Evidence-Based Medicine, Director of

the Centre for Evidence-Based Medicine, University of Oxford,
Dr Thomas Joyce, Reader in Biotribology, School of Mechanical and Systems
Engineering, Newcastle University, Professor Stephen Westaby, Professor of
Biomedical Science, Swansea University, Consultant Cardiac Surgeon, John
Radcliffe Hospital, and Dr Suzette Woodward, Director of Patient Safety,
National Patient Safety Agency
Ev 1
Wednesday 13 June 2012

John Howlett, Head of Notified Body, British Standards Institute
(Healthcare) (BSI), Peter Ellingworth, Chief Executive, Association of British
Healthcare Industries, and Mike Kreuzer, Technical and Regulatory
Executive Director, Association of British Healthcare Industries
Ev 14
Jacqueline Minor, Director of Consumer Affairs, Directorate-General for

Health & Consumers, European Commission
Ev 21
Sir Kent Woods, Chief Executive, Medicines and Healthcare products

Regulatory Agency (MHRA), and Earl Howe, Parliamentary Under-Secretary
of State, Department of Health
Ev 25
List of printed written evidence

1
Medicines and Healthcare products Regulatory Agency
Ev 32
Association of British Healthcare Industries
Dr Thomas Joyce and Dr Pauline McCormack
Ev 44
Professor Stephen Westaby
Ev 48
Jacqueline Minor, European Commission
BSI Healthcare
Ev 41; 51
Ev 48
Ev 49; 51
49
List of additional written evidence

(published in Volume II on the Committees website www.parliament.uk/science)
1
Jane Edwards
Ev w1
Dr Stephen A OConnor
Ev w1
Sheila Sunley, Member of the Altogetherhip Patient Support Group
Ev w3
Centre for Evidence-Based Medicine and the British Medical Journal
Ev w3
Carol Holland, Altogether Hip Support Group
Ev w9
Professor Alan Murray
Ev w10
Action on Hearing Loss
Ev w12
Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians

of the United Kingdom
Ev w13
Medtronic
Ev w16
10
Nuffield Health
Ev w17
11
Royal College of Surgeons
Ev w25
12
Independent Healthcare Advisory Services (IHAS)
Ev w26
13
The Harley Medical Group
Ev w31
14
National Institute for Health and Clinical Excellence (NICE)
Ev w32
15
Dr Gerry Armitage
Ev w34
16
Dr Peter Wilmshurst
Ev w36
17
Johnson & Johnson
Ev w39
50
List of Reports from the Committee during

the current Parliament
The reference number of the Governments response to each Report is printed in brackets after the
HC printing number.
Session 201213
First Special Report
Science in the Met Office: Government Response to

the Committees Thirteenth Report of Session 2010
12
HC 162
First Report
Devils bargain? Energy risks and the public
HC 428
Second Report
Pre-appointment hearing with the Governments

preferred candidate for Chair of the Medical Research
Council
HC 510I
Second Special Report Engineering in government: follow-up to the 2009

report on Engineering: turning ideas into reality:
Government Response to the Committees Fifteenth
Report of Session 201012
HC 511
Third Report
The Census and social science
HC 322
Fourth Report
Building scientific capacity for development
HC 377
First Special Report
The Legacy Report: Government Response to the

Committees Ninth Report of Session 200910
HC 370
First Report
The Reviews into the University of East Anglias

Climatic Research Units E-mails
Second Report
Technology and Innovation Centres
Third Report
Scientific advice and evidence in emergencies
Session 201012
Second Special Report The Reviews into the University of East Anglias
Climatic Research Units E-mails: Government
Response to the Committees First Report of Session
201012
HC 444 (HC 496)

HC 618 (HC 1041)
HC 498
(HC 1042 and HC 1139)
HC 496
Fourth Report
Astronomy and Particle Physics
HC 806 (HC 1425)
Fifth Report
Strategically important metals
HC 726 (HC 1479)
Third Special Report
Technology and Innovation Centres: Government

Response to the Committees Second Report of
Session 201012
Fourth Special Report Scientific advice and evidence in emergencies:

Government Response to the Committees Third
Report of Session 201012
HC 1041
HC 1042
Sixth Report
UK Centre for Medical Research and Innovation

(UKCMRI)
Fifth Special Report
Bioengineering: Government Response to the

Committees Seventh Report of 200910
HC 1138
Sixth Special Report
Scientific advice and evidence in emergencies:

Supplementary Government Response to the
HC 1139
HC 727 (HC 1475)
51
Committees Third Report of Session 201012

Seventh Report
The Forensic Science Service
Seventh Special Report Astronomy and Particle Physics: Government and

Science and Technology Facilities Council Response to
the Committees Fourth Report of Session 201012
HC 855 (Cm 8215)

HC 1425
Eighth Report
Peer review in scientific publications
HC 856 (HC 1535)
Eighth Special Report
UK Centre for Medical Research and Innovation

(UKCMRI): Government Response to the Committees
Sixth Report of session 201012
Ninth Report
Practical experiments in school science lessons and

science field trips
Ninth Special Report
Strategically important metals: Government Response

to the Committees Fifth Report of Session 201012
HC 1479
Tenth Special Report
Peer review in scientific publications: Government

and Research Councils UK Responses to the
Committees Eighth Report of Session 201012
HC 1535
Tenth Report

preferred candidate for Chair of the Technology
Strategy Board
Eleventh Special
Report
Practical experiments in school science lessons and

science field trips: Government and Ofqual Responses
to the Committees Ninth Report of Session 201012
Eleventh Report
Alcohol guidelines
HC 1536 (Cm 8329)
Twelfth Report
Malware and cyber crime
HC 1537 (Cm 8328)
Thirteenth Report
Science in the Met Office
HC 1538
Fourteenth Report

preferred candidate for Chair of the Engineering and
Physical Sciences Research Council
Fifteenth Report
Engineering in government: follow-up to the 2009

report on Engineering: turning ideas into reality
HC 1475
HC 1060I (HC 1655)
HC 1539I
HC 1655
HC 1871I
HC 1667 (HC 511,

Session 201213)
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Science and Technology Committee: Evidence Ev 1
Oral evidence
Taken before the Science and Technology Committee
on Wednesday 23 May 2012
Members present:
Andrew Miller (Chair)
Gareth Johnson
Stephen Metcalfe
Stephen Mosley
Pamela Nash
Graham Stringer
Hywel Williams
________________
Examination of Witnesses
Witnesses: Dr Carl Heneghan, GP and Reader in Evidence-Based Medicine, Director of the Centre of
Evidence-Based Medicine, University of Oxford, Dr Thomas Joyce, Reader in Biotribology, School of
Mechanical and Systems Engineering, Newcastle University, Professor Stephen Westaby, Professor of
Biomedical Science, Swansea University, Consultant Cardiac Surgeon, John Radcliffe Hospital, and Dr Suzette
Woodward, Director of Patient Safety, National Patient Safety Agency, gave evidence.
Q1 Chair: I welcome our panel of witnesses this
morning. Just for the record, may I ask the four of
you to introduce yourselves?
Dr Heneghan: My name is Dr Carl Heneghan. I am
from the University of Oxford.
Dr Joyce: I am Dr Tom Joyce from Newcastle
University.
Professor Westaby: I am Steve Westaby from Oxford
and also from the Institute of Biomedical Sciences at
the University of Swansea.
Dr Woodward: I am Dr Suzette Woodward. I am from
the National Patient Safety Agency.
Q2 Chair: Thank you very much. I have a series of
questions for you and I will start on the issue of
regulation in the field of medical implants. We have a
regulatory structure that has a UK component, and it
operates within the broader EU arena. Does that
relationshipthe decentralised nature of the
structuregive you any concerns about safety in this
field?
Professor Westaby: To a degree it does in that, as you
already know, there are more than 80 regulatory
bodies throughout the EU, and in order to obtain a CE
mark you can go to virtually any of them. Once you
have a CE mark for an implantable device, you can
use it in any European country. The MHRA supervises
the UK very carefully, and I have lots of evidence
with my own endeavours to back that up. Compared
with the United States and Japan, for instance, where
I have substantial interface with medical devices, we
are very fortunate indeed, because I can use
sophisticated devices many years before my
colleagues in the States and Japan, for instance.
Dr Heneghan: I have spent about three or four years
trying to get my head around regulation and how it
works, looking in terms of the evidence requirement.
The key is to understand, from the three European
directives, how the evidence is brought about. You
submit your devicea design dossierto one of the
notified bodies. There are 76 across Europe; you
submit to onewherever the country isand you get
access to the whole of the European market. When
you submit that design dossier, you submit your
potential technical standards and clinical data. When

you dig down into it, what does clinical data mean?
There is a crucial issue called equivalence. All
manufacturers more or less use it. In the US they use
it about 95% of the time; here, I dont know, but I
expect it would be round about 100% of the time.
Equivalence means that you can write a literature
review that says, My device is very similar to
somebody elses on the market and so I should have
access to the whole of the European market. That is
then looked at by a notified body. As of now, that is a
non-transparent process between the manufacturer and
a private company, and nobody, including the MHRA,
gets to see the quality of that data, as submitted, what
it looks like and how much it establishes
effectiveness. I am not going to come to safety yet
we will come to that later. Is this device equivalent or
is it better than something on the market?
Right now, probably nobody in the European Union
has a perspective on that, because it is a nontransparent process that hides behind commercial
confidentiality. I have access to that in an ongoing
case right now, as an expert witness in evidence in
transvaginal tape meshes, where I have the
information submitted, and that is the only way I can
get access. That non-transparency in the quality of
evidence is a real problem.
Q3 Chair: Professor Westaby, going back to your
response, are there examples you can give of
approvals that have been given by one of the 80
regulatory bodies that specifically give you concerns?
Professor Westaby: To be honest, not in my field. I
am sure that the recent PIP breast implant is the focus
of attention here, but I think that was a fraudulence
issue. If the regulatory authorities are told that a
certain content is present in a device, they are justified
in taking that as accepted. I dont personally have
experience with a device that I think should not have
been used. I have had experience with a heart valve
that was licensed and then caused issues. There were
two well-known ones. The LabCor valve was
implanted at six or seven centres in the UK; it was a
safe and durable device, but it was sterilised in a
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Ev 2 Science and Technology Committee: Evidence
23 May 2012 Dr Carl Heneghan, Dr Thomas Joyce, Professor Stephen Westaby and Dr Suzette Woodward
material that could cause corrosion of biological

materials. There were clear instructions as to how long
that particular valve should be washed before it was
implanted. In certain cases, because of certain
techniques, the valve was not washed for long enough;
there were nurses in the operating theatres whose
English was not good enough to scrutinise the
instructions before use, and there were issues, but it
was not the valve itself. I have not actually used a
product that was questionable from the point of
regulation.
Dr Joyce: Much of my work has been concerned with
a group of devicesmetal-on-metal hips. Within this
group, we are seeing substantial revision rates and
substantial failure ratescertainly a lot more than
would be expected from conventional types of
artificial hip joint. Those that have failed have all been
through the regulatory process and have been CE
marked and checked, but when it comes to pass, they
have failed a massive amount. That is with hips.
If we look at something like finger joints, they have
been fitted in relatively small numbers. If we look at
the literature, the LPM finger prosthesis failed in
about 50% of cases after about 15 to 18 months, and
the Mathys finger prosthesis failed in 76% of cases, at
15 months again. Although these are small numbers,
they are substantial failures and they have presumably
been CE marked and checked, yet they are going into
patients and performing incredibly poorly.
Q4 Chair: Is there any evidence that the regulatory
structures outside Europesay, in the US or Japan, or
indeed anywhere elseare better than the European
one?
Dr Heneghan: I can answer that. The US system is
slightly different in that they have two systems. They
have one called the 510(k) route, which is their
equivalence route, but they have a second route called
the PMA approval process, which they use for the
highest-risk devices. The idea there is to say, Im
sorry but you cant use equivalence and you have to
establish clinical trial data to use this product in our
population. I can give you a whole list of about six
different ones that have not been cleared in America
but were used in the European market.
Hips are a classic example. You had a 3% failure rate,
which is a very impressive revision rate, at about 10
years, and then a new device comes along on
equivalenceand it is a technical equivalence, not a
clinical improvementand now you have failure rates
of 13% or 15%. Whoever is responsible for the
regulatory framework there is in trouble, because their
job is to catch that. The key is that we have a system,
and you have to remember that there are about 76
different joints available, which does not include all
the combinations. There are loads of these floating out
there trying to gain access to a very competitive
market.
Q5 Graham Stringer: Are you saying that the metalto-metal hip joints were allowed on the basis of an
equivalence test alone?
Dr Heneghan: Nobody knows this. A notified body
has looked at the data and approved it. Nobody knows
the make-up of notified bodies or their skill base, and
nobody knows their transparent process of approving.

At least in the US, when somebody puts in a process,
I can get hold of all the 510(k) information and the
clinical PMA off their websites. If we were to do one
thing the next time, it should be to provide a bit of
transparency so that at least you could look at it and
say, I wonder what clinical data was submitted.
There will be manufacturers who are conscientious
and do this really well, with an evidence-based system
in place, but there will clearly be manufacturers who
usurp that. The answer is that I dont know, and I
very much doubt that anybody knows apart from the
manufacturer and the notified body; the MHRA
certainly does not know.
Professor Westaby: I have just one comment. For
many years the top American companies, such as
Medtronic, Edwards, and Boston Scientific, have
routinely tested their products in Europe. I have been
in a position on many occasions to have had the
privilege to use excellent new American technology
five or six years ahead of the Americans themselves
and then gone across to the FDA to present our
findings, which they then approve. There is no doubt
that the US uses European patients to test their
devices, but that is a two-edged sword. We get
fantastic technology earlier.
I am very positive about MHRA and how it works. I
took a concern to it about the particular heart valve
that I mentioned and how it was being washed and so
on, and the fact that I had confidence in the valve but
not in the way that it was being dealt with. Its
response was very prompt and effective; it did a very
good job in preventing the sort of scandal, which
would have been completely inappropriate, that we
saw in the PIP implants. In my view, MHRA is very
much under-resourced. It does not have enough
people. There are hundreds of thousands of medical
implants, and it is simply not resourced to look at
them all. PIP was very unfortunate.
Q6 Stephen Metcalfe: Do you believe that there is
no role for equivalence, therefore, in assessing class
III implantsthat it is too risky?
Dr Heneghan: You have to get your head around it.
Say that Stephen here makes a wonderful device and
takes it to a clinical trial, and it is shown to be
effective. The problem is that you dont incentivise
anybody to do that, because the problem is that
manufacturers around the world will then use
equivalence to start making devices that may be
slightly cheaper and come to the market. The problem
is that we have no system in place to incentivise
people to produce evidence.
The problem with the system is that it is expensive to
do clinical trials, and most device manufacturers are
not like drug companies with 20 million or 30
million floating around; they are in the innovation
stage and dont have the money to do the trials. We
have to get our heads around equivalence. The FDA
in America will be moving their high-risk devices to
PMA and asking for clinical trials on all those
devices. You might say that that is anti-innovative, but
you should ask yourself where all the companies are
located around the world for making devices. People
should be aware of the framework of quality, if we
cobber Pack: U PL: COE1 [O]

want to build high-quality products and not lots of tat

and rubbish. I am sorry about that, but that is the
problem that we are facing. We will build these
systems and then have other companies with
equivalence come on board.
Professor Westaby: I dont think that equivalence
works. My biggest research thrust is with miniaturised
artificial hearts, which are rapidly becoming
equivalent to cardiac transplantation. I believe that
they are very important, because the heart failure issue
is a global epidemic and we have an off-the-shelf
solution to it. However, you cannot say if one device
works in an animal for five years that it will work in
a human. We have had some big surprises that way.
The way we have to test devices in this country and
in the States is with animal work. I have tested an
American device; in fact, I did the first permanent
implant here and got the worlds longest survival with
any type of artificial heart. People like me have to do
this work with animals in order to get class III devices
implanted, but there is overt hostility in this country
to animal work and we dont feel protected, so I have
had to go elsewhere to do it.
Q7 Stephen Metcalfe: For those particular types of
device, do you think that there should be an explicit,
specific requirement to have some clinical evidence
before they are approved?
Professor Westaby: Yes.
Q8 Stephen Metcalfe: Does anyone disagree with
that?
Dr Heneghan: The system in 1976, as it was brought
around in the USA, was expected never to have
equivalence for implantable devices, but they were in
a bind for pre-existing devices. So it was said that
there were some devices from before 1976 where you
could use equivalence but any device from 1976
onwards should have clinical trials. The great thing
about industry is that if they can get round anything
they will do it, and they have got round that to such
an extent that the majority, even in the US, is
equivalence, and they are worried about that. Even the
metal hip went into the US system for equivalence,
passed through the FDA and got used in their market.
That has been a real bind for them and a problem, so
they are coming to what you are insinuating. They are
calling it total product lifecycle evidence: you build
pieces of equipment, and they may go wrong in 20
years, so you have to build with quality for the long
term, and that requires trial data at the outset.
Q9 Stephen Metcalfe: If we move from the use of
equivalence data to more clinical data for the higherrisk devices, will that delay their arrival into market?
You commented on having the ability to use products
perhaps five, six or seven years before they get
approved by the FDA. Will there be less of a benefit
to the patient by moving to an alternative system?
Professor Westaby: There could definitely be, but I sit
on a Food and Drugs Administration committee
relating to artificial hearts and it has recognised that
things have got to change dramatically. Your artificial
heart is an example of the epitome of implantable
devices. If one stops, the patient dies, and I have had
that in this country. To test one of these miniature

artificial hearts costs a company $1 million per
weektheir clinical trials cost $1 million a week. I
have a device, and I want it to go into humans soon,
but my little company cannot afford $1 million, full
stop. The FDA recognises that it has radically got to
change the way that it looks at devices and licenses
them. The clinical trials have got to be made
accessible and far cheaper than they are now, because
right now it just does not work. Animal work, as I
say, does not necessarily translate into what you find
with a human; there have been big surprises in the
translation of animal work to humans. It has to be
clinical, but it has to cost less. In my view, the NHS
has got to support it far better than it does.
Dr Heneghan: Can I give you a perspective? It will
delay things, but that is not a bad thing actually.
Let us take a simple device, such as a blood pressure
machine, which is an important device. If that
machine is not accurate, it could have profound
implications for who gets treatment and who does not.
Beyond the CE system, the British Hypertension
Society and the European Society of Hypertension
have worked out that they need clinical studies,
kitemarks and protocols to stamp on these devices to
say they are accurate. That is profoundly important if
you are going to put a million people on treatment,
because if the machines are not accurate we will have
major problems. We do it better for simpler devices
than we sometimes do for the high-end devices.
Will it delay things? Yes. With a new drug on the
market, would you expect to say, Lets just see how
it goes on for a few years, and after a few years you
put it through trials and then get NICE to look at it?
The perspective is that MHRA is a different body
from what NICE is and does for you. NICE says, Is
this drug safe and does it have any benefit for
society? That body is not in place, so there is an
argument that you could look at something like NICE
and say, What is NICEs remit? There is a medical
technology committee, a device committee and a
diagnostic guidelines committee. Its remit should be
to put a stamp mark on products and say, Yes, this
will give us some benefit.
Q10 Hywel Williams: I dont want to go off on a
tangent about NICE, but doesnt NICE operate
differently in Scotland from the way it operates in
England and Wales? It is a quicker process in
Scotland. I might be wrong about this. Is there
anything to be learned by comparing and contrasting
as far as this particular issue is concerned?
Dr Heneghan: Certainly, and there is a lot to be
learned about international collaboration as well.
Q11 Stephen Metcalfe: Why do you think those two
separate paths have been developed? Why do you
think NICE went down the route that it did, with
evidence-based clinical assessment, and we have not
done the same for implants, which you might argue
could have an equal impact on the patient?
Dr Heneghan: Yes, you could say that. NICE was set
up for a postcode lottery in drugs and medications.
They said, Weve got people using drugs over here
and they are not using it there, particularly in areas

such as cancer; we need a perspective across the

NHS. It is an amazing innovation to say that that is
what we do, but then people moan because they have
to wait a bit longerbut you are better waiting.
Professor Westaby: May I just say that I am on the
NICE Medical Technologies Advisory Committee? Its
remit is only to look at devices that are submitted for
assessment by companies, and there is a paucity of
devices submitted to NICE to look at. The American
companies will not go anywhere near NICE; they can
market their products without being involved with
NICE. There is an understanding that NICE is a
lottery; it is based on cost containment, and most
important devices never go anywhere near NICE.
Dr Heneghan: However, the flipside to that is in the
US medical area in their purchasing activity. They do
their own sort of technology assessments and work
out the value for money and effectiveness before they
decide to pay for it.
Q12 Chair: Before we move on, may I ask you, Dr
Woodward, what you see as the patient perspective on
this part of the debate, on delays versus the benefits?
Dr Woodward: May I slightly clarify the role of the
National Patient Safety Agency? It is about looking at
the whole system and trying to make it as safe as it
possibly can be in a proactive and reactive way in the
incident reporting system that we run. We run a
national reporting system, and anything that could
possibly go wrong in the NHS is usually reported to
us. From our perspective, we look at what it feels like
and how it is perceived by patients, but it is also very
much related to staff and how staff feel when things
go wrong.
From a patients perspective, you absolutely expect
that when you are going to go in you are going to
have the right thing put in the right place at the right
time. That is what you should have, and that is also
what you expect, so you dont question it. If
somebody says you need a replacement, you dont
question where the replacement is coming from,
whether somebody has tested it in the right place or
whether it is the right piece of equipment for you. If
somebody tells you that you need a hip replacement,
you sweetly say yes, sign the consent agreement, and
go into surgery. When you come out, if things go
right, that is fabulous, but if things go wrong, it is a
very hard system to cope with. When things go wrong,
you are rarely told that they have gone wrong, and
you are rarely told why, and you dont quite
understand what can be put right for you as an
individual. You also start to become very fearful of
the system. You dont come back into it because it
doesnt feel right; that frightens you, so you dont
want to have it happen again. It is a very confusing
scenario for patients when things go wrong, and it is
almost an ignorant system before they go wrong
because you believe that everything is going to be
right.
Q13 Gareth Johnson: Professor Westaby, I presume
that decisions that you make about which particular
implants to use for your patients are based on medical
need and the available information that you have at
the time about medical data. Do you suspect that any
decisions you have made would have been different if

you had had full access to the pre-market medical
data?
Professor Westaby: No, I dont believe that any
clinician working in the NHS ever gets access to the
pre-market data at all. At clinician level, you are
provided with an evidence base to some degree,
depending on experience, and this is where registries
are very important. There are now registries for all
types of implant, and registry data tends to be more
instructive than clinical trial data, because a lot of
what is published in terms of clinical trial is done by
enthusiasts in the best units under ideal conditions. In
contrast, registry data tells you how everybody has got
on with the product and you can pick up variables
from registry data.
Q14 Gareth Johnson: Professor Westaby, we have
heard calls today for a far more transparent system
than is currently the case. Presumably, one of the
reasons those calls have come forward is because it
would have an impact on patients.
Gareth Johnson: In what way do you think it would
change the medical decisions that you have made if
we had a far more transparent system?
Professor Westaby: I have always been an academic
to a degree, so I have always looked for an evidence
base for products before I have used them. That comes
from a massive amount of literature in journals. I have
to say that most devices in clinical use are sold by
enthusiastic representatives.
It is not so long ago that trips to international
conferences, pens, biros and everything else were
given out by companies, and clinicians would make
subjective assessments on which type of heart valve,
pacemaker or stent to use depending on the
representatives that they liked the best and the
companies that looked after them the best. That is the
way that the English market has worked for an
awfully long time. I think there is regulation about
that. In the United States the regulations about these
things are very tight now, and I think it is similar in
the UK now. You are not allowed to make judgments
depending on which rep you like the best.
Dr Heneghan: That is not the case. In America, they
have a thing called the Sunshine Act, which means
that the companies have to post exactly how much
they may or may not be paying the individual, so you
will be able to look up and see if Dr Carl Heneghan
has received any money from one of these companies
or manufacturers. That does not occur in the UK.
Again, that is a great transparency issue. A lot of it is
about being able to trust your clinicians to make good
decisions and them not having conflicts of interest,
and having access to the information to make the best
decisionsthat is what we are here about. At the
moment, that clearly is not happening and most
problems arise because it is still going on and there is
a potential for conflicts of interest to occur. I, and you,
have no way of knowing who has such conflicts of
interest, but I can tell you that I have not been paid
any money by anybody.
Dr Woodward: May I talk about the transparency
issue in relation to the work that we have done, which

might give you some clues as to how to think about

taking things forward?
We were very nervous in the early days of making our
data as open as it could be. We collect 1 million
incidents a yeararound 3,000 a day. That, to a
member of the public or a patient, could be a huge
cause of concern3,000 things are going wrong in
the NHS every day. If you put it in the right context
and look at the levels of harm associated with those
incidents, only a very small minority lead to severe
harm or death, but you also need to be open about
that. That creates a feeling of trust between the public,
the patient and the data that you have and, therefore,
the system in itself. What you have to do is to back
that up to show that the system wants to learn from
that information, so we dont just collect it and stick
it out in statistical form; we collect it, send it out and
say, This is what we are doing about it. I think that
creates a different relationship.
That also leads to a much better informed patient. For
example, with surgery we have something called a
surgical checklist. When patients go through the
system, lots of things are checked off as they go
through. Many doctors were very reluctant to use that,
surgeons in particular, because they felt that
undermined their clinical expertise. I know what Im
doing. Why do I need a checklist? But, actually, it
empowers surgeons, the teams and the patients. They
then use that to go through the system, feeling as if
they are part of that system and not just being done to.
The transparency of the data is incredibly important in
creating a different relationship between patients and
the health service.
Q15 Gareth Johnson: May I follow up on that? In
your particular role, if we had a greater degree of
transparency in the system, would any data protection
issues for patients or patient confidentiality issues
arise because of having a far more transparent system?
Dr Woodward: We have to adhere to all of those
things, obviously, and the things that we report go
through a certain level of filter so that individual
patients would not recognise themselves in something
that was made public and so on unless they had
consented to it. You would not issue incident data that
was very much related, say, to one speciality that was
dealt with in one hospital that probably only 10
patients had experienced over the last year, because
that has the potential to identify those people. We are
very careful about data protection and confidentiality.
However, in presenting this data, you can be very
creative in explaining the statistical data that you have
in a way that does not mean that patients say, That
was me. They could say, That kind of scenario sort
of happened to me, but not, That was me.
Q16 Graham Stringer: There are obviously
exceptions, but there are many different standards
among the regulatory bodies in southern and eastern
Europe compared with northern Europe. Is there any
sense that manufacturers can cherry-pick where they
go for authorisation for devices?
Dr Heneghan: Is there any hard evidence? No. Is
there anecdotal evidencefor instance, when you
look at the minutes of meetings of the FDA or the
MHRAand they bring that out and say that there is

an aspect that is a cultural issue that is known about?
Some exists in the minutes of MHRA meetings, but
nobody has any hard evidence of that at the moment.
Professor Westaby: There are very definitely
tendencies to direct your research to areas where you
are likely to get ethics permission early for certain
things.
I have a lot of trainees in Greece in units. I support
heart failure units there that are starting to use
artificial hearts. I can do far more in Greece that is
wholly ethical much faster than I can in the UK. As
an example, I am using miniature blood pumps instead
of cardiac transplantation and using stem-cell therapy
to make the native heart better. Now, I can get ethics
approval for that in Greece, where it would take me
two years in Oxford. All clinicians do this; there are
American companies that will go straight to South
Africa to test devices first. It is very easy to selectively
go to areas where it is easier to get ethics committee
approval in order to make your advances more
quickly. That is not a lack of integrity; it is a very
practical aspect of getting medical devices and new
techniques accepted. You have to target your patient
population and get ethics committee approval for
doing your clinical trials; and, naturally, companies
will go where they can do that quickest.
Dr Heneghan: We did some work with the BMJ on
metal-to-metal hips, and one of the notified bodies in
this country is BSI, which put the kitemarks on. We
got into trouble because we did not realise this. We
said that BSI must have looked at it and given it their
stamp. It was interesting that they came back and said,
We dont even look at the product, so you got it
wrong, whereas it will look at prams or toasters and
put its BSI stamp on them. We made a mistake, and
we held our hands up to it when they said that. That
gives you a whole host of loopholes, if you dont even
see the product. It is a completely odd system that
allows all these things to happen.
Q17 Graham Stringer: If it can be used to make the
treatment or the medicine more efficacious, can it also
be used to get round the system so that less good
equipment can get into the market quicker? Do you
know what the balance between those two things is?
It is probably an impossible question to answer.
Dr Heneghan: You would need to have access to look
at that. It is simple.
Q18 Graham Stringer: Going back to the metal-onmetal hips, was that a regulatory failure, inasmuch as
they should never have been allowed on to the market,
or was it a regulatory success, in that they were found
to be dangerous in some way and were withdrawn
from the market?
Dr Heneghan: That is two questions. There was a bit
of both there.
Dr Joyce: It is a failure. We speak to many hundreds
of people, and these lives have been absolutely ruined.
I would like everyone to go away with that reality.
We have been here before. With the 3M Capital hip
in the 1990s there were questions in Parliament, and
the Royal College of Surgeons set up a committee,
which said that there is no such thing as a small

change. So we come back to the idea of substantial

equivalence. I have this amazing sense of dj vu.
That was approximately 5,000 patients in the UK and
Ireland. When the DePuy ASR hip was withdrawn in
2010, there were nearly 100,000 worldwide. We do
not know the exact number of this group of devices,
metal-on-metal hips, but somewhere between 500,000
and 1 million people worldwide have been fitted with
these devices.
Dr Heneghan: It was a success of the registries, but
it was a success of the Australian joint registry in
2007. We have a system, but there are problems with
our registries and our regulators. No. 1 is that they are
not independent enough, potentially. No. 2 is that they
are not taking heed, and I dont know whether they
dont have the skills or the framework to say, We
could have known this in 2007. Interestingly, the
Australians had a very comprehensive joint registry in
place, and Tom would know more about this. It was
telling the messages then but they were ignored. There
is plenty of information that I could send to the
Committee to show that they were systematically
ignored because the make-up of some of these bodies,
including our National Joint Registry, was not
independent.
Professor Westaby: The important point here is that
the public get access to a lot of medical science
through the media, and they get hope related to
medical advances. If you are dying of heart failure or
cancer and something appears that you can see will
clearly help you with your last couple of years of life,
you want access to that treatment. With long-term
medical implants such as hips and blood pumps
artificial lungs are on the wayand all sorts of
exciting technology, you would have to embargo
widespread use for something like 10 to 15 years
before you got your outcome data. When the BBC and
Fergus Walsh say that stem cells and blood pumps are
the future for heart failure and so on, and it goes out
on the BBC and Sky, the patients are on top of you,
and you simply cannot say, We have to wait 10 years
for long-term trial data.
We are up in the air with this, and there is no good
answer. Registry data, as I intimated earlier, is
important. Surveillance is important, and MHRA does
it well. You have to take a leap of faith with devices.
You have to look at them carefully when they appear,
but you have to give the public access to the
technology, and you then have to watch it with
registries and regular surveillance. That is the way that
you will pick up problems, but you cannot deny
technology to the patients.
Dr Woodward: One point that you made was that
regulation was a success because it picked it up. One
of the crucial things is the speed of picking it up and
the speed of response. If you take the aviation industry
as the gold standard and places such as Toyota, they
have a system whereby, if something goes wrong with
one airline or even one flight, it is known throughout
the system within about 12 hours. That is what we
need for the NHSa system whereby, if you pick up
really quickly that something is going wrong, rather
than wait for months and months, you need to be able
to spread it around really quickly. Toyota has a system
called stopping the line. The moment you know that
something is not quite right, you stop the line. What

we would want to happen when somebody picks up
that things are going wrong is that you stop any future
surgery or implanting or whatever, until you know that
it is safe to start again.
Q19 Graham Stringer: Collectively, your evidence
is very interesting and getting increasingly scary. Who
should be responsible for post-market surveillance?
We have had some evidence that clinicians do not
report failures and difficulties as quickly as they
should. What are the barriers to clinicians reporting
problems?
Dr Woodward: We have studied this to a great extent,
because our work is not wholly dependent but largely
dependent on having a very good reporting system. If
you know about the stuff, you can actually start
doing something about it. So we work very hard to
identify those barriers and to address them. There are
a large number of them; I shall give you some, but
not necessarily in the right order, as it were.
There is the lack of feedback. If you report something
and you hear nothing back, you say, What was the
point in me doing that? There is the issue of
immediacy. If something is going wrong, you deal
with what is going wrong. You deal with the patient,
the family and the issues. By the time you have done
all that and ended your shift, you will want to go off
and do not necessarily come back and fill out an
incident report. Incident reporting systems are seen as
highly bureaucratic. Performance management
systems make you end up feeling that you as a person
or your colleagues are being blamed, rather than the
organisation, the group or team that you are in saying,
This has obviously gone wrong. Lets see if we can
learn from it. We need a culture of learning rather
than punishment.
All those issues to do with time, bureaucracy,
immediacy of action and the lack of feedback lead to
not reporting. There are a number of crucial things
that you can do, which are obviously the opposite of
all of those, to encourage people to reportmake it
feel worthwhile, give them lots of feedback, make it
a learning system and make them feel supported when
things have gone wrong. There are some fantastic
lines about The best people make the worst
mistakes. People dont go into the health service
wanting to make it go wrong; they go in wanting to
do their absolute best. They are traumatised
themselves when things go wrong, and they want to
learn just as much as the system wants to learn. You
need to create an environment within which they can
do that.
Q20 Graham Stringer: What is the proposed market
surveillance system?
Dr Heneghan: There are a couple of issues. First, we
need to ensure that manufacturers do this, and this is
coming back to the PIP implant, which is quite an
interesting one. In America, if you make a change
even to the industrial grade silicone, you have to tell
the FDAyou dont have to do that in Europe, by the
way; we can change products in Europe. When they
asked manufacturers to look into all breast implants at
the time, they lost 80% of the follow-up because it is

quite technically challenging to run registries. I do

think there is a role, and No. 1 is to think about having
a national system for all implants and it becomes
mandatory to put in anybody who has a joint put in.
There are systems coming on board that will allow
these devices to be trackable. That is simple; it is like
a barcode system. We can be world leaders in this
with the NHS and we can ensure that everybody gets
into the system.
The flipside of what we are talking about from the
National Patient Safety Agency viewpoint is the
second thing. For drugs, there is a very valuable
system called the Yellow Card system, which is now
embedded even within the electronic systems of
primary care. If I see a drug that is giving you an
adverse effect, I can send that off. That has been going
for about 50 years, but there is no equivalent system
for medical devices. It is quite absurd; it is like a
website, if you can find it: it is so hidden in the back
of the MHRA that you have to really search for it.
Have we got a scary problem? In the five years that
we have looked at this, there has been a 1,220%
increase in the number of field safety notices. That is
the number of manufacturers saying that problems are
occurring. We are trying to help you, I hope, with a
system. At the moment it is continuing to rise and be
problematic. How do we get a system that is
innovative but is also safe for patients? It can be
achieved, but we have to start using some of these
systems to help.
Professor Westaby: I have done over 11,000 open
heart operations now, and I have used more than 2,000
heart valves, hundreds of vascular grafts and many
types of artificial heart. I would like to give you the
confidence that primary device failure is extremely
rare. It is very, very, very rare in the NHS. If you hear
that a device has failed, there are several reasons why
that might happen. Devices can wear out earlier than
expected because of patient factors. A lot of devices
go down because of poor patient compliance. Heart
valves and blood pumps need anticoagulation, and if
the patients dont take their pills the devices can go
down with clotting and that sort of stuff. That is not
because the device does not work but because the
patient has not been compliant. The last thing is that
inappropriate utilisation of devices can account for
alleged device failures. However, I would go right
back to the original statement. Primary device failure
in the medical profession is, in my view, extremely
rare, and you should have enormous confidence in the
way things are.
My biggest issue in this country is access to lifesaving technology. I wont go into it, but the NHS
rations life-saving technology in a way that many,
many more lives are lost through that than through
devices going down.
Q21 Pamela Nash: A few people who have
submitted evidence to the inquiry suggested that it
might be helpful to expand the National Joint Registry
to include all implants, although Dr Heneghan has
indicated that its independence is compromised at the
moment. Would an expanded registryor an
equivalent, if you would like to suggest onebe
helpful?
Dr Heneghan: That is a great point. The first thing

is, how many hips failed?
Dr Joyce: It depends on the data you look at, but it
was about one in two DePuy ASRs or about 50%.
Dr Heneghan: How many was that in absolute
numbers?
Dr Joyce: Somewhere up to 100,000.
Dr Heneghan: I am sorry, but I dont see how that
can be rare. This is one where I could give you a
number of examples. Medtronic was mentioned
earlier; its bone cement was used off-label. That has
been all over the world, and they are looking at that.
There are a number of devices, including breast
implants, so it is not rare.
With the joint registry, there are two things we want
to do with devices. No. 1 is to work out whether it is
cost-effective and does it make a difference or at least
whether it is equivalent to what we already know. You
can do that with benchmarks as well, saying that after
three years you should expect to see things in the
context of a trial. The second thing is that, when you
put it on the market, a registry is set up to be a quality
assurance system. You dont know, but in 10 years
cancers could appear, or in 15 years devices may fail
catastrophically. It should be a quality assurance
system; it should not be designed to be about
causationOh, it went really well. The argument
now is that we have only had device registries since
2003, so we dont know enough about the long-term
consequences. We should expect devices to fail, but
we should also see them as being complementary to
sets. There is a three-year benchmark for hips with
NICE to say that you should get 3% revision rates at
least and if you are above this you are out of range.
Q22 Pamela Nash: Do you think that this can be
made from the existing NJR or do you think that we
need to rub it out and start again?
Dr Heneghan: No, I think it can be within the
existing NJR, but you need to think about who is
going to run that, and its nature, structure and
independence. You should think about how it ensures
quality and that it provides information really quickly
when it finds out what is going onnot that it delays
information. We could sit in a room and think, Well,
lets wait a year, but that is potentially damaging.
Q23 Pamela Nash: The key point of my question is
whether we should expand this to include all medical
implants and not just joints. Is that something that
would be helpful?
Professor Westaby: There are thousands and
thousands of medical devices that impact directly on
the body, and many hundreds of implantable things, if
you include fillings in the teeth and so on. There is a
big difference between one device failing lots of times
and a large proportion of devices failing. I will go
back and say that the vast majority of devices have
been proven to be safe.
All devices will wear out sooner or later. Clearly the
hip issue is very serious, because it needs revision. If
a blood pump packs up, the patient can die. One of
my patients died when his blood pump stopped, but it
was because he had not taken a spare battery out. It is
as simple as that; it is about compliance. When

implants fail, there is a large amount of emotive stuff

around it, but I personally have confidence in what I
said previously and that surveillance right now by
MHRA is good. What you have to do is to persuade
the clinicians to provide you with the data.
Q24 Pamela Nash: You also said that you did not
think that it had the resources to do the job properly.
Do you think that we now need to set up a registry of
all implants that are used within the UK?
Professor Westaby: Registries are very good, and it is
worth all class III implants having registries. Many
companies have their own registries. The valve
companies and the pacemaker companies want
feedback. They are very keen to know if any of their
devices go wrong. The current level of integrity in the
device market in my view is very high and the
regulation of the device companies in the States is
very good, andlets face itmost of the devices that
we use come from the States.
Q25 Pamela Nash: The fact is that most of that
information is not centralised anywhere if it is
registered by the company.
Pamela Nash: And the next part of my question is
whether we should be publishing data from the
registry as it stands at the moment and if we were to
expand it, which we cannot do if we have different
registries.
Professor Westaby: Cardiac surgeons a long time ago
set up a heart valve registry, a registry for mechanical
assist devices and so on and so forth. You will find
that the medical profession in many areas sets up its
own registry, and this is happening more and more
often. We feed information to the Department of
Health and MHRA, and, if all branches of the
profession did the same as the cardiac surgeons, then
you would have the information that you want.
Dr Heneghan: You can take a perspective that is
cynical or of being on the sidelines, but let us go back
to the analogy of Toyota. If you own a Toyota car and
there is a brake failure in one car, they know how to
alert and get hold of everybody and draw them back
in. If you have a failure in your joint, or in your x, y
or z, we have no system in place for saying, Lets
use this to alert the 8,000 people who now have the
system to make them aware. That does not happen,
and that is absurd. Your car is in a much safer position
than the stuff that we put inside your body. That is
what we are talking about.
Q26 Pamela Nash: Given my understanding of this,
which you are expanding rapidly, would that not be a
function of MHRA rather than a registry?
Dr Heneghan: No. The MHRAs job is just to
respond to manufacturer alerts and/or clinicians who
alert them to x, y or z. Given how it is set up and its
role in the system, it is in a bind. It can only impact
on what it can do. All that it is saying is that it
responds. It could take a more neutral viewpoint and
say it could have more clinical data and so on, but it
says it only responds. You could argue, in the case of
the hips, that it could have responded earlier and taken
a more uncertain viewpoint as opposed to this

certainty viewpoint.
Dr Woodward: The MHRA sends out some alerts that
alert the service to certain concerns on the use of
devices or medicines. There is something about the
timeliness of that which could definitely be speeded
up. Actually, it is similar to the system that we have
when we produce things called patient safety alerts or
rapid response reports, as they are currently known.
Lots of national bodies can send out as many alerts as
they like and as much guidance as they like, but the
crucial thing is implementation and compliance. There
is a big gap between what we tell them should be
happening and what they actually do. The key
question is how we manage that bit. Is that the role of
regulation, or is it the role of the local provider to
police or monitor that, and how do we monitor it?
We currently have a system called the central alerting
system, or CAS for short, and people self-report their
compliance with an alert. If we send an alert in
January 2012, we expect it to be implemented in
fullwe usually give them a yearby January 2013.
Over a certain period we expect them to report back
to say, Nearly compliant, Nearly, nearly
compliant, and Compliant. That is self-reported,
and you can only spot check some organisations to
see whether they truly are compliant or not, and we
expect the Care Quality Commission in our respect to
do that.
At the moment, we have 99% compliance. Lots of
people say that that is fantastic, but I disagree. I think
that 1% non-compliance is really poor. You would not
expect to go on an aeroplane or take a train journey
and think that 1% of the things that they are supposed
to be doing have not been implemented. You would
be scared from point A to point B on your journey.
Why should it not be the same in the NHS? If you are
issuing an alert and it is because there is a problem
you have really good evidence that there is a problem
and you can tell people that they should be doing
something about itpeople should be compliant with
that, and that is a big issue.
Dr Heneghan: There is a real problem with timeliness
here. The MHRA committee on safety of devices said
in 2006 that there is growing concern over the
biological risk of metal wear debris, yet it was March
2012 before we came to a decision. Going back to
your other industries, I cannot imagine getting on a
plane and saying, We have a problem with wear
debris. How does that get communicated? People
need to say, Hey, we need to draw back now. We
need to stop and think about patient safety. There is
an issue here that we should not be sitting here doing
this now; we should have been sitting here four
years ago.
Q27 Pamela Nash: Before we move on, Dr Joyce,
you mentioned in your evidence that you thought it
would be helpful to conserve explanted joints. First,
would you address the earlier points I made? Do you
think that we should have a registry of all medical
implants, and should it be published? Secondly, on the
final point, if you are able to give us any examples of
when that has been of advantage it would be really
helpful.

Dr Joyce: I think that the registry should be expanded

to all artificial joints. On implants, I am not sure
because it depends on the implants. One thing that we
need to point out, which was alluded to earlier, is that,
if you are going to have a heart valve put into a
patient, they are probably in a life-threatening
situation. That might be one situation, but with a hip
with osteoarthritis it is not the same.
The other thing is that pre-market testing is crucial. It
is certainly my experience, in the case of the DePuy
ASR, that there was no need for one of them to go
into a patient. That could have been identified by premarket testing. They had the machines and the
equipment, and those tests could have been done.
To answer your other question on explants, again I
mention Toyota. If there is a problem, what do you
do? You take the thing to pieces and look at it. That
is all that I am suggesting. Similarly, with plane or
train crashes, you look at the bits and pieces
afterwards. At the moment, it is just not done with
hips or knees. Most of them are just thrown away. To
be honest, without the work that we did I am not sure
whether ASR might still be on the market now. We
want an independent centre examining them and then
sharing that information, saying, We think there is a
problem, and having scientific publications produced
which share this information.
Q28 Hywel Williams: We have already talked about
public perception and public understanding of this
entire issue and how important that might or might
not be. We are being broadcast this morning, so there
are at least a few people listening to your evidence.
How important is it that the public understand the role
of the MHRA, notified bodies and manufacturers in
implant regulation?
Dr Heneghan: If you go for an implant, you are
consented. That is the first thing; you are consented to
the benefits and the harm. I wrote this contentious
thing, and Stephen is at the university of Oxford, but
around the world it is the same issue. You want to say,
wherever you are, that we have access to the
information that this is beneficial or this is the harm
that you face. It is really important that the MHRA
and our joint registries promote what we are trying to
do for patientsimprove safety.
Does that happen at the moment? No. We had a recent
thing where these patients get up and tell you what is
going on in their lives, and they question us. They
come to me as a GP and say, Why did somebody put
this in me when they already knew this? Why did we
not have some fail-safes? We were doing this a year
ago, six months ago, so why have I now got this longterm risk that I dont understand? We have to get a
perception of how to communicate directly with
patients. The flipside from the NPSA is that we have
to get a system where they report in more. That would
be wonderful. The patients could start saying, Ive
got a problem with my hip. This is what I want to do.
Where do I go and report that? That would be
amazing.
Dr Woodward: I am not sure as a patient that they
really want to know about the role of the MHRA or
what the NPSA or NICE do. They just want to have
their problems addressed and to be pain-free and
cured if at all possible, or helped and so on. It is

usually when things have gone wrong that they start
to try to find people in the system to help them figure
that out.
On the issue of consent, a lot of people compare the
system in the US with that in the UK. In the US you
are told about absolutely every single possible thing
that can go wrong in major, major detail. In the UK
we are veering towards that, but what you have got to
do is to explain that in a way that is genuinely
understood, because risk is a really hard thing to
understand. If you say that you have a one in 10
chance of this happening to you, what does that really
mean? Do you think that you are the one, or do you
think that you are one of the nine? If you happen to
be the one, will you think that the nine people behind
are okay? I know that I am being simplistic, but it is
a really hard concept to get across to patients.
The other aspect is choice. If you are in a situation
where you need a lot of help and support, you are in
a lot of pain and you are very vulnerable, Dr X or
nurse Y will say, You need to have this. Please
consent. It is a bit like looking at the terms and
conditions to some of the things that you sign up to
on the internet. You just tick I agree and get on with
it. It is only when it has gone wrong that you start to
rationalise why you said yes to this.
Professor Westaby: After 40 years in the medical
profession and at least 35 at the sharp end, I can tell
you that very few patients actively take an interest in
their treatment. They want to know that they can trust
their doctor and that the doctor will give them the best
advice. I am sure that this resounds with you.
No one has heard of MHRA or at least until the recent
issues. There are many bodies involved in safety now,
and it is bewildering for the patients. But, because of
the internet, let us say 5% of patients are avidly
interested in what is going to happen to them. They
tend to be the academics and people who are obsessed
with healthcare. For the sake of those 5% of patients,
I think that we are absolutely going to have to make
information like this available on the internet. We are
going to have to publish registries for different types
of implant. We are going to have to publish mortality
rates for different procedures. It is already happening
in cardiac surgery. Many surgeons are having to drop
out because their mortality rates are already perceived
to be too big.
I shall shut up now, Mr Chairman, because I know
that you dont want to divert into another area.
Q29 Chair: Having listened to Dr Woodwards last
response, I think that some of your colleagues are
going to have to learn how to communicate to patients
in English. Issues of probability are not easy concepts
to put across to patients, especially when they are ill.
Professor Westaby: Absolutely.
Chair: There is a serious challenge to the medical
profession about how to do that better.
Professor Westaby: Absolutely.
Dr Joyce: We sit down with patient groups and let
them talk together. We have focus groups, and they
produce minutes like this; I shall pass these round.
They say things like, Why does a GP ignore tests?,
My GP does not understand the information and

data, It feels like nobody cares about us, When

you stop trusting, it can have a big impact, You are
moved from place to place; you are in so much pain
you will go anywhere. From the MHRA there is a
lack of communication. They have failed. They
shirked responsibility. There are massive issues for
the patients that we talk to about knowing what has
happened and why it has happened, and they do not
want it to happen again. It is an incredibly difficult
place.
Dr Heneghan: May I come in on this issue? In my
experience as a GPperhaps this is a reflectiveI
think that people do want to know what is going on.
Increasingly with the internet age, they are becoming
more sophisticated and more knowledgeable. Boy,
every time they walk in I say to them, What have
you looked up? What do you think is going on?, and
they know what is going on. People do want to be
informed and they do want to know. They take an
interest in what we do, and we should particularly
explain the decisions that we make better, why we do
not have access to certain treatments and why we need
to do this. We do it really poorly, and we need to take
a perspective on that.
can look at it. We do not want to completely shut the

gate down, but we can use that system to promote
innovation at the same time.
Q30 Hywel Williams: How could notified bodies

and manufacturers be more publicly accountable for
their role in certifying products? Should the work of
the notified bodies be conducted by public
organisations such as MHRA?
Dr Heneghan: You are in a bind there, and the
Americans find this. If you try to do it with a public
organisation, you will need a massive organisation and
it will become very costly very quickly. Whichever
way, the manufacturer will have to pay for it. The US
FDA does this. The solution is to make it transparent.
It is to say, if it is a notified body, we are in the UK
and we need the information to be made available.
Lets put it online; lets look at the design job. They
will argue that there is commercial confidentiality in
those documents, but the clinical data should never
be commercially confidential. There may be design
aspects that they cannot give, and I am happy with
that, but let us publish the clinical data. If you did that
tomorrow, I would be on the case working out what
is going on. I have been trying to do it for three years,
and I cannot do it.
Dr Joyce: I agree with that need for transparency.
With artificial hips or knees, they should tell us how
they have been tested and what the results are, and
share it with everyone. If there is nothing to hide,
why not?
Dr Heneghan: There is another route as well. You
dont have to be totally anti-innovative here. There is
a system that the FDA is adopting, which I have
written about, called the IDEAL system. The idea is
that, when you are very innovative, you are in an
investigational device exemption zone. You could
apply to the MHRA, saying that you are going to do
this in the conduct of trials, that all people are going
to be followed up and that for the next three years we
are going to consent people as though they were in a
trial. Actually, we should promote more use of that
of how these things get recorded and registered and
how we understand itso that more innovative people
Q32 Stephen Mosley: Dr Woodward, you talked

about risk in your previous answer. When we were
talking to the MHRA, it gave the quite simplistic case
of bed rails, saying that patients had been trapped by
a bed rail and injured. They looked at it and thought
that it was bad news, but when they actually looked
at the data they found that you were at much greater
risk of falling out of bed and injuring yourself in that
way than you were from a bed rail. You therefore have
to take a risk-based approach.
You can see, with some of these implants, that if
someone is going for a hip replacement they need the
replacement, but if problems occur two or three years
down the line where does the ratio of risk apply?
Are you trying to suggest, between you, that if you
have a situation you should be upfront and honest
about it and say, Look, if you have this operation
there is a 50% chance that it might go wrong in a few
years? Are you saying that that is okay if you are
upfront and honest about it so that professionals such
as yourselves can make the right decision, or are you
saying that that should never happen and that you
should never have a situation where someone suffers
because of a problem?
Dr Heneghan: Let me clear about it so that you
understand. There are three classes of deviceclass I,
class II and class III. The bed rails are a class I device
and you get a CE marking, rather like you get for a
teddy. It is a bed rail, it is to standard and you hold
that documentation. Yes, they will fail, but that is
okay. Actually, there is a system in place that probably
deals better with class I devices because there will be
slight problemshoists fail and all these sorts of
things. That will happen regularly. For that, the
current system is okay because they are low-risk
devices, and you hope that somebody would put up a
better system for patients and the public, probably like
the Yellow Card system, so that you can communicate
that better.
Q31 Hywel Williams: I move on to my final

question. Who should bear the costs of corrective
surgery and public health messages when an implant
is found to be unsafe? For example, with PIP we have
a difference between Wales and England.
Dr Heneghan: If you wanted to fund independent
registries, they are very cheap. When I was in
Australia, it worked out at about 20 Australian dollars
per patient entered; that is one. The first is registries
from a manufacturer.
The second is what is wrong with an insurance-based
system? Here is another analogy. If your plane crashes
or your plane company goes bust and you are in
Spain, they have to get you all back. They will fly you
back. What is wrong with having an insurance-based
system equivalent to the level of evidence? It should
go down as you promote it. If the device has 20 years
and not many problems, you wont need much
insurance; but in the early days it is going to cost a
lot of money for some of these devices.

However, let me be clear that when you are talking

about class III the capacity to do harm to a number of
patients is so great. It is like with a drug; if there is a
problem with a drug tomorrow, we can stop you
taking it. You can have hundreds of thousands of
patients with a hip inside them, who are saying, What
do we do? Can you take it out tomorrow? You can
get rid of the bed rail tomorrow; you can change it;
but you cannot change something that is inside
somebody. So you want to know really quickly what
is going on if it is going badly.
Dr Joyce: On the point about being upfront, most hips
are excellent. It is just some of the modern designs
that have failed. However, when we talk to patients,
they tell us that when they went to see the surgeon,
he said, This will last 30 years. You will be horse
riding and skiing. The patient will say, I have never
skied in my life or ridden a horse. The patient is left
in a situation where they are expecting some brilliant
device that will last for 30 years, and then suddenly
they have pain and they are ignored. Eventually, they
find out that there is a major problem with the hip.
They are not alone. Then there are the long-term
concerns about the potential cancer risk, with these
metal particles travelling around the body, and we still
dont know the long-term implications of that. I think
that no one was upfront about that with the patients
that we speak to.
Dr Woodward: People underestimate the actual skill
required to do a really good risk assessment. You
obviously need to understand the risk of doing
something versus the risk of not doing something.
Then you need to show the risks in the short term, the
long term and the medium term. You need evidence
behind all of that if you are going to do it really well,
so it is not about gut feelings or intuition but about
history and evidence over time. That would cover
your clinical patients and your clinical outcomes, the
research, the audit, the patient safety and incident data
and the case note review methods that people use.
There are also fancy tools that you can use, such as
failure modes and effects analysis and hazards
analysis and all sorts. You need some skills in order
to do that.
Once you have made the probability assessment, you
need to use those skills to turn it into something
incredibly simple in order to communicate it. It is not
as simple as saying, This could happen to you
tomorrow and you need to be aware of that. It is a
balance of probabilities, as they always talk about, and
that is a really hard thing for clinicians to do and a
very hard thing for patients to take on board. Then we
have to weigh all that as a matter of judgment, asking
ourselves whether or not we do it and what are the
options.
Dr Heneghan: In the current situation, it is impossible
to do that because nobody has any data on the
effectiveness of devices. In lots of situations you will
say, We will tell you how it should perform at some
point in the future. It does not matter how much we
discuss the ins and outs; the key for lots of devices
is that we cannot generate the information to inform
patients in the first placeuntil perhaps at some point
in the future.
Q33 Stephen Mosley: Do the MHRA and the other

notifiable bodiesthe regulatorshave the expertise
and the skills to do that?
Dr Heneghan: It is interesting when you look at the
make-up. In terms of organising a regulatory body and
what it should look like, the answer is yes. In terms
of how they look at the data and how they
communicate that data, it is no. The Americans have
realised this and set up a network to support them
from epidemiology and statistics-based centres and
made them independent.
The key is that you want people who will look at the
data and be able to unblind it and produce that data in
an independent and transparent fashion, in a
meaningful way. We already do this with drugs. In
clinical trials you have stopping rules that are built by
smart people, and if things are going wrong they can
unblind it and say that it is not working. There is a
nature problem in the make-up there. It is the same
with the joint registries. You have to think about who
you want, particularly for understanding the data and
the independence.
Professor Westaby: I sense that we are getting down
the line with this. Right now, I would make one
caution. It is that the NHS is becoming so stiff in
bureaucracy that it can hardly move. If we are not
very careful, it will just grind to a halt.
I will tell you frankly that the amount of scrutiny that
was levelled at heart surgeons after Bristol has put
people off in this country from going into the
profession. We have to do the right thing for the
patient, but virtually the whole conversation this
morning has revolved around one breast implant, one
hip and one valve that was not really faulty but which
was not used properly. We would take a long time to
make a list of 20 devices that had gone wrong in this
country. I would reiterate that, if we are not careful,
we will make the whole system so bureaucratic that it
will not move at all.
I shall finish by saying that, when we contacted
MHRA about the anxieties about that one heart valve
that was not being washed properly, an alert went out
about it within one week to every single cardiac unit.
In two weeks the MHRA knew everything about how
many valves had been used and in what centres, and
everything else. I thought that was a very fine
response and they did the right thing. They cannot do
that for absolutely everything because there are not
enough people and, in my view, they are underresourcedlike the whole of the NHS. You will not
be surprised to hear that several eminent members of
MHRA are going to leave imminently. Quite simply,
you can only put so much attention and flak in one
direction before people do not want to be involved.
Dr Heneghan: The key here is combining innovation
with patient safety. That is what we want. We want to
be global leaders in industry and to bring work here,
but when you look at where all the companies are
located most of the device companies are located in
America; most of the drug trials are done in America;
and two thirds of the regulatory trials are done in
America. They have a tougher, tighter regulatory
framework and they are about to make it tighter,
which will incentivise their companies to build higherquality products. In the end, you will acquire quality

and you will win. In the short term there will be

lower-quality products; yes, you will have lots of little
industries making a lot of little bits of devices here
and there, but we want to be the Formula 1 of the
industry. That is what America has realised. So the
argument does not wash when people go, Well not
have a business if we become more regulatory.
American has already done it, and it is winning.
Q34 Stephen Mosley: Turning to the PIP breast
implants, I think it was you, Professor Westaby, who
said that it was not a problem with the regulations as
such. It was more that the application was in effect
fraudulent. They were claiming that there were
different things in them, basically. Should the
regulators just be looking at the data that
manufacturers supply, or should they be looking to see
whether they are doing as they say? Should they be
looking beyond the data? I know that you can do that
in the long term if you have a registry and look at
how effective things are, but when someone comes
upfront to get approval, should you just be looking at
what they are telling you or should you be trying to
get behind it?
Dr Heneghan: There is a perspective here. You may
say for very high-risk devices that the MHRA should
at least take a sample of them and say, Lets audit a
sample of theseperhaps 10% or 20%. You have to
start somewhere. We cannot suddenly say tomorrow
that we are going to put a load of work on here; you
will need to increase the work load. You would start
with some perspective and say, Lets start towards it
with a sample and then move forward. If you find
problems you will have to expand that, but if you
dont find problems you can carry on with the audit.
That is exactly what the FDA is doing. The FDA even
go out and visit manufacturing plantssurprise,
surprise. Do we do that in Europe? No. Will we be
able to effect the EU regulatory framework to do
anything? Probably not, but we can effect our
regulator.
Professor Westaby: You would have to disassemble
and chemically analyse every implant that was
presented to you. The number of independent experts
needed to do that, even before you started the clinical
assessment of a device, would be massive. You are
pushing us towards a situation where the whole thing
will be so stiff with bureaucracy that it will not move.
On cardiac transplantation, I can tell you that if we
applied the stringent criteria that we are suggesting for
devices to donor organs and donor hearts you can
forget it. That would be transplantation gone right
now.
Q35 Chair: Let me assure you, Professor Westaby,
that we are not pushing you anywhere. We are simply
seeking evidence.
Professor Westaby: No; I know that.
Dr Heneghan: May I come in here? In the USA,
Steve Nissen looked at the American system and the
number of devices that had failed. For cardiovascular
devices, there were 76; that was the highest, so there
is a lot going on. What Steve Nissen found, which
was a really interesting issue for the FDA, was that
90% of them had gone through the 510(k) route. Of
the ones that had gone through the pre-market

approval process, very few failed. Some
manufacturers are incentivised to produce evidence in
clinical trials, but those who build a wonderful piece
of kit have not got a system in place to stop somebody
six months later using a 510(k) equivalent to bring the
same piece of kit to the market. With global
expansion, the number of equivalent devices is going
to get worse.
Q36 Stephen Mosley: How important is the MHRAs
committee on the safety of devices? How effective is
it at giving expert opinion? Should it operate more
transparently that it currently does?
Dr Heneghan: I have been looking at this for three
years, so I know quite a lot about it. First, there is an
issue about declaring and thinking through the conflict
of interest issue, what it should be, what the make-up
of that should be and what is the best perspective to
do that. At the moment you have a mixture of people
from industry and non-industry on it. At the end of
the day there will be conflicts of interest. I have
conflicts of interest; everybody does.
The second issue is that we should start to expand it,
because it is not big enough to deal with the numbers,
the size and the amount of work load going on. You
have just one device safety committee meeting every
few months, and it is not big enough. The complexity
of the issues is important and difficult, and I dont
think it is currently equipped for that role.
Q37 Chair: I have one final question. One of the
things that is happening in the world of medicine is
this extraordinary convergence of technologiesfor
instance, the way in which engineering is now so
fundamental to medicine. Are we heading towards a
regulatory problem in some respects? For example,
Professor Westaby, some of the stents that some of
your colleagues put in will release chemicals.
Chair: And there are other devices that are designed
to release medication into the patient. Is a point
arriving when the convergence of pharmaceutical and
engineering technologies and surgical skills will
require a different approach to the regulatory
structure?
Professor Westaby: It is there already. For instance, I
use plastic tubing that is coated with heparin. I am
working on a total artificial heart with a professor of
bioengineering, who is going to line the device with
stem cells so that the propensity for clotting within
the device is that much less. Yes, the complexity of
artificial organs is moving on at a great pace.
One very interesting thing that has not been
mentioned is cost containment in devices. Every one
of the small artificial hearts that we can use instead of
transplants these days costs the same as a Porsche car.
It is a tiny thing, so why does it cost the same as a
Porsche? It is not that it is more complex. It is because
of all the regulatory issues and risks associated with
an implantable device. To get around that and to make
this sort of thing accessible to British patients on the
NHS, we put together a company to make a far less
expensive device that is probably even better, but it is
here in the UK. We are doing that, and there is a lot of

interesting work going on in the UK that will combine

biology with mechanical technology. It is becoming
very interesting, and it is going to be very good for
patients. For enormous groups of patients, like heart
failure patients, there is an enormous imperative to get
this technology available quickly. If we make
regulation more bureaucratic, there will be another
whole generation that we cannot treat in the way we
should, according to current medical science. That is
why I am kind of worried about anything that will put
the brakes on more than we have already.
Dr Heneghan: That is a very good question. What
you have described is a device with a drug in
heparin or stem cells. That means that it has to go
through the drug regulatory pathway and through the
usual clinical trials. It will require two randomised
trials to be implemented, and it will then be submitted
to NICE guidance. Take the heparin out of the stent
and you dont need any of thatyou can use
equivalence to bring it to the market.
The key of what you allude to is whether we are going
to look back in time and think that it is ridiculous.
Yes; it is a bit like 50 years ago with drugs, when
we had a situation with Thalidomide, and look what

happened then. Under the current system, if we dont
do something different, at some point a device will
come on the market that will cause something
catastrophic that will make people stand up. Currently,
we have not got that yet.
Dr Woodward: This may be a very simplistic answer,
but my simple approach is this. As the system gets
more complex there should still be the same
principles, no matter how complex it becomes, or how
innovative or technical it becomes, or how much more
technology there is. The simple principles are: is it
safe, is it effective, does it meet patient needs, does it
pose the least risk and all those things? There are
some key principles that will apply no matter how
complex the health service becomes.
Chair: May I thank the panel for a very informative
session this morning? If you have any additional
thoughts, we would welcome a note from you because
this is clearly an issue that is considerably more
complicated than most people realise. Thank you very
much indeed.
cobber Pack: U PL: COE1 [SE]

Source: /MILES/PKU/INPUT/023457/023457_o002_th_S&T 120613 Medical implants HC 163-ii Corrected.xml
Wednesday 13 June 2012

Members present:
Andrew Miller (Chair)
Sarah Newton
Graham Stringer
Roger Williams
Gareth Johnson
Stephen Metcalfe
Stephen Mosley
Pamela Nash
________________
Witnesses: John Howlett, Head of Notified Body, British Standards Institute (Healthcare) (BSI), Peter
Ellingworth, Chief Executive, Association of British Healthcare Industries (ABHI), and Mike Kreuzer,
Technical and Regulatory Executive Director (ABHI), gave evidence.
Q38 Chair: Gentlemen, I welcome you to this
mornings hearing. For the record, I would be grateful
if the three of you would formally introduce
yourselves.
John Howlett: I am John Howlett from BSI, a UKnotified body.
Peter Ellingworth: I am Peter Ellingworth, chief
executive of the Association of British Healthcare
Industries. We represent the medical technology
industry.
Mike Kreuzer: I am Mike Kreuzer, the director in
charge of regulatory affairs for ABHI.
Q39 Chair: Perhaps I may start with you, Mr
Ellingworth. Tell us a little about whom you represent
in the field of implants and why it appears that none
of the businesses was prepared to come and give
evidence this morning.
Peter Ellingworth: We represent the medical
technology industry in its broadest sense. That is
everything from simple syringes and dressings all the
way through to active implantable devices. The
industry itself employs about 64,000 people; it is
comprised of many small and medium-size enterprises
in the UK. We probably represent about 75% of that
industry, and we have in the order of 250 members.
We operate with a mandatory code of practice for our
membership as well. Our job is to represent that
industry and to provide a broad industry perspective
on major issues. Essentially, our role is to ensure that
we create a positive environment for the uptake and
diffusion of technologies that are safe and effective
for patients.
Q40 Chair: And the second part of my question?
Peter Ellingworth: Indeed. As far as we were
concerned, it was our role to represent the industry,
and the decision by companies is entirely up to them.
We do not have any particular authority over those
companies.
Q41 Chair: You are not particularly surprised that
none of them wanted to be here and explain to us how
good their products are?
Peter Ellingworth: Indeed. We are more than happy
to be here and to do that representation for them, but
there are no particular issues from our perspective.
Often they would expect us to take that role, and
certainly we will speak openly and frankly about any

issues you wish to raise.
Q42 Stephen Metcalfe: Did any of the companies
who had been approached ask you to represent them
here?
Peter Ellingworth: No one has particularly asked us
to represent them. We get involved with the
Department of Health, BIS and many other
Government Departments. It is normal business for us
to represent those who are our members rather than
any individual company. We will not talk for an
individual company. If you ask me a particular
question about a company, I would not answer that
simply from an equity perspective, but, broadly, I am
very happy to discuss anything that you wish today.
Q43 Chair: I want to move on to you, Mr Howlett,
and ask some questions about equivalence data. If the
other panel members have comments they want to
make, please feel free. Are you content to rely on
equivalence data when certifying new implants?
John Howlett: Our role as a notified body is to ensure
that the manufacturer meets the essential requirements
for clinical data established in Annex X of the
directive, supported by guidance in MEDDEVs, and
the clinical data are established through literature or
literature and a clinical investigation. If the
manufacturer goes down the literature route, which
is essentially the equivalence route, the guidance is
well established, and as a notified body we follow that
guidance. We do not make the rules; we implement
them. The system is different from the one in the FDA
with their equivalence. We do not work with the term
equivalence. The data have to be sufficient in
literature or literature and trial form to meet the
essential requirements of the directive.
Q44 Chair: Is that because there are difficulties in
conducting clinical trials in some cases?
John Howlett: The decision on a trial has to be made
in the first instance by the manufacturer. Trials are by
nature costly for the manufacturer to set up, but we
challenge the manufacturer on the availability of the
data. In the FDA, the equivalence aspect is based on
a predicate device; our measures are really against the
essential requirements of the directive.

13 June 2012 John Howlett, Peter Ellingworth and Mike Kreuzer
Q45 Chair: If I were a customer for an implant, I

would want to know what data were being relied on
to give me some confidence in the product that was
going to be put inside me. Would it be better if that
information was available to the patient and the
doctors?
John Howlett: I think transparency of the data to
support compliance would be beneficial. That is a role
for the regulators. The notified bodies cannot make
that information public, but, in the interests of
transparency, I would support that. I think it would be
better, yes, to have a clear indication so that the
public, in the interests of patient safety, can visibly
see the route and compliance either through clinical
literature or trials.
Q46 Chair: I noticed that Mr Ellingworth was
nodding at that point. Transparency of data is a simple
thing, but would more stringent regulations risk losing
some of the industry to overseas manufacturers?
Peter Ellingworth: Of course we would have to take
a look at what was required, and proportionate is
always a good approach. Safety comes first. The
industry is going to support anything that improves
safety. We are supportive of improving transparency.
The devices directives have been around for 20 years
now and have been through a number of
improvements. With any process, we are supportive
of continually improving it. There might be some
requirements that could be an issue for smaller
businesses because they have more limited resources.
Essentially, the UK is made up of 2,500 small
businesses in this sector, but, of course, every problem
has a solution. We would be very positive about
anything that improves patient safety.
Q47 Chair: Your understanding would be that we
could mandate the issue of transparency to British
companies, but as to things that have been approved
in other member states, could we mandate it to them?
Mike Kreuzer: No. It is a pan-European system and
works in the same way right across Europe.
Transparency is an extremely important topic. Greater
transparency will be introduced in the revision that is
currently taking place. There are plans for that, which
I am sure you will be hearing about later from the
European Commission, and it is something we
completely support. There is definitely a need for
greater transparency.
Q48 Stephen Mosley: Mr Howlett, could you briefly
explain the resources and expertise that the BSI have
in order to assess implants?
John Howlett: I am sure you have read the guides we
have put through. A conformity assessment essentially
is made up of two parts. Most manufacturers would
go through an Annex II route, which would require a
quality system assessment. We have in excess of 200
assessors around the world doing medical and
conformity assessments. Then it is based on the
technical documentation and on classification. As to
an implant, generally we are talking of IIB, which is
high to medium risk; if we are talking about any of
the up-classified items, like hips, knees, shoulders and
breast implants, we are talking about class III. As to
our expertise, we have highly qualified reviewers from

industry and the universities where they have been
involved in the design and development of those
particular products.
Q49 Stephen Mosley: Moving on to the faulty metalon-metal hip replacements, in particular the degree of
recall, do you think a breakdown in regulation allowed
these faulty metal-on-metal hip implants to be used in
the EU market for so long?
John Howlett: We have talked about transparency.
With any device there needs to be a strong postmarket surveillance system. Much work has been
done, and all of us as notified bodies are looking at
that in greater detail against current expectations.
Post-market, it is all about having early warning
systems, gathering of data and registries, and that
information would give an early warning about the
medium and long-term events that would happen with
a device.
Going back to the equivalence or clinical trials, we
have to realise that the metal-on-metal device has
been around for decades. What we have seen recently
is not an indication of a failure in all those devices.
The devices have performed against their essential
requirementsthe test methodsand we and the
manufacturers would have tested against those
standards. Short-term compliance on wear and fatigue
is all carried out in the design phase.
The medium and long-term effects have to be coming
from post-market. It is unreasonable to think that we
can predict 10-year performance if we are looking at
hip joints and, say, 90% success after 10 years. It is
not reasonable to think that you can do that through a
clinical trial. It is a combination of test data and doing
all you can to demonstrate patient safety in the short
term, and then monitoring for any further medium to
long-term effects through the post-marketing phase.
Q50 Stephen Mosley: You have said what needs to
be done and you have given a good idea of what
should be done. What was actually done in this
specific case? Was all of that done or not?
John Howlett: I cannot answer on specific cases. As
a notified body we work with a number of clients. I
can talk in general terms. The notified body would
assess the manufacturers databench testing
because, obviously, you do not want to put any
patients at risk initially. You do all that you can
through bench testing, literature and clinical trials as
best you can, but you will not get trials that will
continue for 10 years. Patients have to be considered
in this, to bring innovative and good technology to
patients use, and to follow up the medium and longterm effects is not reasonable. In any situation where
we have a manufacturer, we would assess the
companys system, design dossiers and technical files
against those essential requirements.
Q51 Stephen Mosley: I can understand you not
wanting to talk about particular things, but can I
specifically ask about the impact on BSI? Do you
think that BSI has suffered reputationally because of
the recall?

John Howlett: I would hope not. We are in a highrisk business. The products that go to the market have
to show benefit over risk, and that is a judgment the
manufacturer has to make. It is a judgment that the
notified body has to challenge and agree with if it is
to certify that product. We are assessed in doing our
duties as a notified body by the MHRA. We are
rigorously audited both in the office and on site for the
audits. I believe that our application of those duties is
in compliance.
As to reputation, I could not really answer that. I hope
people would see that, as a leading notified body in
this industry, that would be recognised, and recognise
that, although we get small numbers of devices that
may show some fault, in the main, the system is
generating devices for patients to ensure patient safety
across many hundreds of thousands of patients in the
EU, which are performing perfectly satisfactorily.
Q52 Stephen Mosley: Could I just ask the other
witnesses, and also add this: what do you think the
public accountability should be of the notified bodies?
Peter Ellingworth: Public accountability is taken care
of in the Medical Devices Directive. One thing I
would like to comment on is the National Joint
Registry, which is a fantastic aspect of what we have
in this country. Clinical registries, led by the cardiac
one several years ago, are a great way of ensuring
patient safety and continuing to ensure it. Again, they
can be built on. The National Joint Registry is now
mandatory, and it looks at revision data. We are now
engaged in discussions to see how that can be
improved further to continue to try to pick up aspects.
Mr Howlett is correct in saying that the real challenge
is about doing a 10-year clinical trial, but the National
Joint Registry is there and is a real asset for us in this
country, and we can continue to work on improving it
with clinical professionals as well.
Mike Kreuzer: It was the NJRthe National Joint
Registrythat picked up the metal-on-metal issue in
this country.
Q53 Roger Williams: I was fitted with a metal-onmetal hip about four years ago. It seems to be working
very well, but last year I was recalled to the hospital
where it was fitted and I had an x-ray and blood
samples were taken. At the same time, I received a
letter from somebody volunteering to represent me in
any legal case I could take against the firm. Can you
tell me from where that information was likely to
come, and should my medical history be in the
public domain?
John Howlett: I personally could not answer that.
Peter Ellingworth: No, I do not understand where that
information would come from. Mike Kreuzer: I have
no idea.
Peter Ellingworth: I believe that in the case
Mr Mosley mentioned, they are taking great pains to
make sure that patients are looked after, but they
would not be sharing any information about patient
names. That really is quite strange. I do not know
where that would come from.
Roger Williams: Thank you. I will continue my
inquiries.
Q54 Sarah Newton: I would like to pick up where

my colleague left off on auditing and particularly ask
John Howlett about how the MHRA audits BSI and,
in turn, how you audit manufacturers.
John Howlett: I believe the MHRA is one of the
strongest and most recognised of the competent
authorities in Europe. It audits us regularly with
auditors who understand the quality systems side and
with product experts to assess what we are doing in
terms of a review of the dossiers. It would also send
in its clinical experts to look at our review of clinical
data that we talked about earlier. I believe that is a
very robust system. Representatives from other
member states have joined those audits by the MHRA.
We are one of the few where there has been a common
playing field and even, consistent application, with
people coming from other competent authorities in
Europe. In addition, it audits us on all the medical
directives. We are talking here mainly about MDD 93/
42 for implants. It would observe us carrying out
audits of manufacturers during our surveillance cycle.
Our audits of the manufacturers follow all the
guidance in terms of the harmonised standards that
support the directives. We are auditing the
manufacturer against the requirements of the
directives and all the MEDDEV guidance that goes
behind that. We are involved in improving the
guidance. We work with the Commission at NB-Med
and Team-NB meetings in pushing for and getting
better guidance in that area. Obviously, we are not the
authors of that; we help and inform, but we operate
against that guidance. As a notified body that is all we
can do, and we lobby for improvements in the areas
that we do.
I think BSI has been very strong and instrumental in
doing that. You have probably seen from the papers
we have provided that on NB5 we have a code of
conduct that is generated by the notified bodies to
improve the regulation, so it has come from within the
notified bodies. In the absence of greater control from
outside, we have helped generate that with a number
of the other leading European notified bodies to the
point where the Commission are looking very
favourably at that initiative to improve the consistent
application of our work against the directives.
Q55 Sarah Newton: How many of the BSI members
you have approved through the audit process have you
subsequently found to be wanting in some way and
not meeting your high standards?
John Howlett: That happens. I could not give the
numbers offhand, but that does happen with any
robust auditing process. It has to be recognised that
the majority of manufacturers wish to take a product
to the market that is going to be in the patients
interest; they do not want to have problems with their
products. Taking on that aspect and the fact that the
notified body is doing all that it can to do that leads,
hopefully, to an improvement in patient safety.
Q56 Sarah Newton: It would be helpful if perhaps
subsequent to this meeting you could provide that
information.
John Howlett: I could give more information on that.
When we are looking at situations where a

manufacturer is found wanting, the first line of

approach as a notified body is to bring that
manufacturer into compliance. We do not want to be
denying the patient the product; we want that product,
if it is a good one, to be brought to the market in a
safe condition. We would work with them and agree
corrective action plans. Very often in that situation, if
the temperature gets too warm for a client that is
failing, most would comply with a corrective action
plan, and we would work with them to get back into
compliance. If that did not happen, it would not be
unknown for the manufacturer to look elsewhere for
another notified body. Clearly, there are choices.
Currently, there are 78 notified bodies, not all full
scope against the directives, but there are other
alternatives. That is one area in which we have
lobbied for further support, because a manufacturer
can choose to go elsewhere, and before we have time
to suspend or withdraw a certificate we may find that
that client is cancelling its certification. That is the
major type of non-compliance that ends up with us
not being the certification body for that company.
We are working on that. It is most important to have
greater transparency on that as well. I think the code
of conduct to which I referred earlier is one way of
improving the situation to avoid that downward spiral
in shopping for an easier route. Very often that can be
in terms of clinical data as well, if the expectations
become too much. That is something about which the
Commission are very aware. They are working on it,
and we support them in their approach to that.
Q57 Sarah Newton: I am sure that is very reassuring
to all of us who have had anything inserted inside us.
Sometimes you approve overseas manufacturers. Do
you also audit them to the same high standards?
John Howlett: That is something that is not fully
understood. As a notified body, we are designated by
the competent authority in the UK to do our work. As
a notified body, any manufacturer in any country in
the world can apply for CE marking through BSI. You
do not have to go to your national body; you can go
to any. That is a factor. We do all our audits to the
same standard. The qualifications of the reviewers and
auditors are exactly the same, whether they are
supplied in the European area, Asia or the US. In the
medical devices area the US is a big market; there are
many clients there. I can reassure you that what we
supply in terms of the audits, irrespective of the
geographical region, is consistent.
Q58 Gareth Johnson: I would like to concentrate on
an issue that you have just touched on: the lack of a
central body and the need to use notified bodies, the
argument being that there is a path of least resistance
somewhere and a manufacturer can shop around. You
said there were 78 organisations, if I heard you
correctly.
John Howlett: I think that is the current total.
Q59 Gareth Johnson: Can you let the Committee
know what kind of relationship the BSI has with the
various notified bodies? What dealings and workings
do you have with them?
John Howlett: I think we have already covered some

of that, as you will appreciate. We go regularly to the
NB-Med meetings in Brussels. I represent BSI on that
committee. We are members of a voluntary
organisation called Team-MB also, which is there to
benefit and improve the guidance we give to notified
bodies. In addition, I mentioned the NB5 where, as an
initiative, we have tried to define the requirements for
reviewers and auditors and achieve a common playing
field and consistency in those audits. I think we have
a good relationship and we respect the other respected
notified bodies. It is perhaps not too clear whether all
are operating at the same level. It is a perception that
many have that it is not a level playing field. I think
our relationship with the other leading notified bodies
is to try to achieve a transparency that will give
greater awareness of the designation of those bodies
in order to achieve consistency in their delivery.
Q60 Gareth Johnson: You mentioned the
weaknesses of the notified bodies, but is your opinion
that, if you did have a central body in Europe, for
example, that would give an overall better
performance? Would you support having a central
body in Europe?
John Howlett: Whatever process is put in placeI
am sure a more robust system will come init is not
really for BSI or the notified bodies to judge what that
should be. How it is achieved is not too important, but
there is a need for transparency and for the competent
authorities to be accountable for the designations that
they give within their own member states. In the legal
or regulatory framework each member state is
responsible for designating its own notified bodies,
and they are the ones that are designating and
monitoring. In my view or in the view of BSI, there
is not sufficient oversight of that activity. Who should
do it, I suppose, would be open to discussion.
Q61 Gareth Johnson: What if we moved to a
situation where we retain the notified bodies but also
have the check and balance of a central body?
John Howlett: I was talking of having a central body
or accountability for the decisions on designation.
What you are touching on is perhaps a central
designation or another step in the licensing or
approval for the high-risk devices. That would be a
different discussion.
Q62 Gareth Johnson: If you had a situation where
you still had those notified bodies but a central body,
too, what impact do you think that would have on the
notified bodies in terms of their accountability,
responsibility and so on? Do you think that would
diminish or increase?
John Howlett: I think the current system is robust.
We must not lose sight of the fact that the process has
been in place for 15 years plus. You have to look
at the successes that it has achieved and perhaps not
necessarily get drawn into the unfortunate
performances of one or two devices. Widespread noncompliance is not there; the vast majority have been
compliant. We have to take that into account first. If
there was another stepif you like, a central review

we would not be against that. If you look at the current

system, that process is already in place.
For a device that has a medicinal substance in it, we
have to do a medicines consultation with the
Medicines Agency; if it has animal tissue or human
blood derivatives, then again we have to involve
another authority. I can see a situation where, if you
have new technologies and specialist areas, you would
draw in another authority to aid that decision. I do not
think it is for us to judge what should be the
regulatory framework, other than saying that we
should work with what we have got and at ways of
improving it in some of the ways we have put in our
papers to the Commission and yourselves in
preparation for this meeting.
Q63 Chair: Mr Howlett, you are a very experienced
engineer with a lot of time under your belt working in
high-level quality assurance, including your work in
BSI. You are sort of implying but not saying that
somewhere in those 78 there are notified bodies that
do not meet your rigorous standards.
John Howlett: Yes, I am. That is certainly an
implication there, and it is a perception in the whole
industry. I think my colleagues here may well wish to
comment on that. The only evidence we could have
for it is that, where manufacturers have sought CE
certification and perhaps have been going through the
equivalence route, as we have called it, or the clinical
literature review without clinical trial data, and we
have felt that is necessary to meet the requirements of
the directive, it has perhaps led to manufacturers
going elsewhere and for the product to appear on the
market some two or three months later perhaps with
a CE mark from another body, without any further
clinical trial data. The only conclusion we can draw
from that as a notified body is that the other notified
body that has picked up that manufacturer has
accepted data that in our view are not supportive of
compliance with Annex X of the directive.
Q64 Chair: And greater transparency would aid that
process.
John Howlett: Greater transparency would help
enormously in making that visible to people.
Peter Ellingworth: Certainly we would agree with the
statements about improving the overall quality. Patient
safety is of paramount importance here. It is not just
about bringing technology on to the market; it has to
be safe. Anything that is done to improve the quality
of the notified bodies is a step in the right direction.
In the work we are doing within Europe at the moment
in Brusselsmy colleague Mr Kreuzer will comment
as wellis about reducing the number of notified
bodies, which is something we will support, and about
increasing quality. It is an iterative process, as we said
earlier on. Everything we can do as we get examples
of how to do things better we shall continue to pursue.
Mike Kreuzer: Coming back to the point about a
central body, we do not believe that is needed. What
is needed is better co-ordination. The system as it is
set up at the moment is actually pretty good. What is
needed is better co-ordination between the competent
authorities and how they designate the notified bodies.
That is my first point here.
That will lead to fewer notified bodies because, as

you get stricter designation, there will be a process of
attrition and a lot of them will fall out of that.
Although I would not want to be quoted on this, I
have picked up rumours that at least two or three
notified bodies have got out of the medical business
in recent weeks because they can see which way the
wind is blowing. We would support that. We think that
in absolute terms there are too many to run the system
properly, and there are too many in the sense that
many of them are not doing the job they should be
doing.
Q65 Graham Stringer: This is very worrying
because peoples health is at risk. In this Committee
you are speaking with full parliamentary privilege.
Can you tell us which notified bodies you do not think
are hitting the right quality standards?
Mike Kreuzer: No, I cannot tell you that precisely, but
certainly none of the ones in this country are involved.
Q66 Graham Stringer: Can you tell us about ones
in other countries? The issue is that people are going
to these bodies in other countries and that enables
their products to be used in this country, does it not?
Peter Ellingworth: The companies we represent take
patient safety incredibly seriously, and finding a quick
or easier route is not in their interests and not in their
long-term interests because it is not going to be an aid
to patient safety. Your point, Mr Stringer, is absolutely
right. This is about making sure that everything can
be done to make devices as safe as possible. There is
no intent on the part of the companies we talk to and
deal with to do anything to circumvent that process,
but in the European Union there are 27 member states.
We do not have sight of those. We have comments
from people as we meet them in Brussels, and we are
expressing our general concern. There is not a great
body of evidence that says that body A and body B
are more or less qualified, but because we have a
concern we are raising it. If we had the examples, we
would certainly share them with you.
John Howlett: The only thing I can addit has been
expressed in Brusselsis that, if a leading notified
body loses a manufacturer to another notified body, it
knows that it has lost that manufacturer but it does not
know where they go. That is a very clear statement
that the transparency is not there. From that
perspective in the UK, perhaps that question would be
best put to MHRA, who would be co-ordinating with
the other member states on that particular issue. I do
not think we could give you any more information
on that.
Peter Ellingworth: Moving notified bodies is not
necessarily that easy. We talked to one large
manufacturer recently and had a very comprehensive
discussion on these matters. They said they wanted to
work with a strong notified body. They are involved
in the process and development of a product, which
may take seven years. The regulatory process here is
not just a question of developing the device, getting
to the end and going through a tick-box exercise. This
is a very complex and involved process. They said
that to change a notified body would probably take
them six months or more and would involve

considerable expense, as they understood the new

processes and went through the necessary quality
assurance. Largely, it is in the manufacturers interest
to stay with a good notified body because it will have
a professional relationship and understand how it can
continue to improve.
Mike Kreuzer: The important thing to understand also
is that the thrust of the revisionthat part of it that
concerns notified bodiesis to tackle this very
problem.
Q67 Chair: Formally or indeed informally, has there
ever been a case where a whistle-blower has come
forward and said, Im not happy with the way this
has been transferred to another notified body? Has
that come to your attention privately or otherwise?
Peter Ellingworth: It is a great question, but no.
Mike Kreuzer: Notified bodies have been de-notified.
That has happened.
John Howlett: I would support the comments made.
The majority of manufacturers want to do the job
right. They want to be with a strong rather than weak
notified body for the purposes of demonstrating
patient safety and the robustness of their system. They
do not want to be left exposed by a cut in scope of
the designation of a notified body. We need to put in
perspective how often this occurs. I do not want to
indicate that this is a massive problem at the moment
in terms of extent. We talk about improving the
system. We have all recognised that that is an area
where it can be improved. I do not want to overstate
the number of times it happens, but it can happen.
That is the issue that I would like to raise.
Peter Ellingworth: Companies want to work at the
highest level they can because they are operating in a
global environment. With todays instant media, a
story can travel very quickly. If it is a global
corporation, it immediately has a global reputation.
For many British businesses, their ability to export is
also at stake here. One of the things this Government
and the prior Administration have done is to pick out
the life science industry and medtech as being the
cornerstone of sciences in the UK. There is a massive
opportunity here for UK businesses to do well on a
global stage, but, to do that, patient safety has to be
number one. The effectiveness and positive impact for
patients and health systems is the second thing in
there, and being seen to be part of a good process is
only going to stand them in good stead as they go out
into the wider world.
Q68 Stephen Metcalfe: For absolute clarity, in the
example you gave where someone moved from you
to another notified body, was that a British company?
John Howlett: It has happened. I cannot recall one
with a British company, no.
Q69 Stephen Metcalfe: But, where it has happened,
the motivation in your view has been that your
requirements were too stringent and it was easier to
get it approved somewhere else?
John Howlett: It has certainly happened, and more
than once. We are required to give information to the
competent authorities on certificates granted,
suspended, withdrawn and refused. There is a
mechanism in place to share that information, but it is

not strong enough in the eyes of many people.
Q70 Stephen Metcalfe: In light of that and the fact
that you can see quite a wide range of quality
thresholds that some of the notified bodies might
apply, post-market surveillance is even more
important. I am sure we all agree with that.
Presumably, that is how we ensure that the product
once into market is performing in the way it was
predicted to perform. Can you take us through what
that process of post-market surveillance is, please?
John Howlett: Yes, I can go through that. With regard
to the guidance for post-market surveillance and
particularly post-market clinical follow-up where we
are talking about a plan for a specific product, if we
are looking at post-market surveillance in the wider
sense, it is gathering all information. Post-market
clinical follow-up is a requirement where we have a
plan post-market for a new product going to the
market. All of that can come forward in terms of
gathering that information. How do we cover that? We
do it in many ways. There are requirements on the
manufacturer in regard to any incident or complaint.
Obviously, the complaint has to be recorded in the
hospitals and authorities; otherwise, it does not get to
the notified bodies or manufacturers. That is the first
area. A lot of people would have a view on thatthat
not enough incidents are being recorded at the point
of the incident.
Q71 Stephen Metcalfe: On that very specific point,
is that a passive or proactive process?
John Howlett: The complaint, obviously, is not
proactive, but there are other mechanisms to gather
that information from surgeons, groups and whatever.
That is what I would describe as gathering postmarket production experiences. If you are looking at
specific product-related follow-up, this is something
you have to use. You cannot have a clinical trial; you
cannot deny a patient a product for 10 years while you
go through a trial. It has to be a combination of
clinical data plus follow-up. We would be looking for
the manufacturer to give us a robust plan where they
will gather that information, probably from a range of
patients, almost like a trial to gather that information
in. How would we look at that? In a number of ways.
Our audits from the quality system side will be
looking at the complaints and vigilance reporting of
those incidents that gets through to the competent
authority. The MHRA as our competent authority
requires us to be copied in on all those incidents. That
is not a mandatory requirement in the regulations, but
it is a requirement on all UK notified bodies. We
monitor that through our surveillance, so that
information comes in on the complaints.
On the other post-market gathering of information,
again you follow that through on the audits but on a
product-related basis. If you are looking at a productrelated certificatethe class IIIs, where you have a
design examination certificatethere is a periodic
review of those certificates. The maximum period is
five years, and that is what we adopt. In those five
years the company can make changes and extensions
to ranges or changes to the design. At each one of

those events or prompts, there will be a review of the

performance of that particular product. It is very much
proactive in gathering that information and for us as
a notified body to monitor it.
Q72 Stephen Metcalfe: Is that information then
made available to clinicians, or even the public, in a
centralised form so that they know they are getting
the best possible product and have the best possible
opportunity to choose?
John Howlett: What we are talking about is the
visibility or lack of visibility of that information
outside the notified body and manufacturers area.
Q73 Stephen Metcalfe: But can a clinician access
that information easily or not? I understand what you
are saying.
John Howlett: No. There is no framework for them
to require or gain that. They could go to a
manufacturer and ask for that information. I cant
answer for what success they would have in those
requests.
Mike Kreuzer: Again, that is one of the improvements
foreseen in the revision of the system of the directives.
Peter Ellingworth: I come back to the registries. They
are a great way not just to track patient safety but also
to look at how things can be improved for the future.
There is a lot of work to be done there, and we are
very supportive of some of Earl Howes recent review
and improvements there. I think there is an
opportunity. As to the revisions, let me give you an
example. This is a pacemaker from 20 years ago. It is
quite a weighty thing. You would not want to pop this
in your top pocket. That is todays. There is a huge
move towards improvement for patients and
outcomes. The battery life is a lot longer. There is less
need to go and have more invasive surgery today; it
is more comfortable. The changes made to devices are
there for real, positive patient reasons. Patients are at
the centre of what we do as an industry. If they were
not, this industry would not be what it is. Every day
in this country, 38 million people have contact with
anything from a simple to a complex medical device.
Q74 Stephen Metcalfe: I accept that, but what we
are trying to do is work out what happens when it
goes wrong or there is something at the margins.
Peter Ellingworth: And that is where we have to be
continually vigilant. I completely agree with you.
Q75 Stephen Metcalfe: Therefore, I am sure that for
the vast majority, the relationship with the registries
will be a positive experience. How do the
manufacturers and registries see their relationship? Is
it as partners working for the benefit of the patient or
as regulator and regulated?
Peter Ellingworth: As partners. The original device
was the size of a car battery, but there is a unique
relationship here, unlike many other industries, where
clinicians and companies are focused on the patient at
the centre of this exercise and how they work together.
Nothing is developed purely on a bench; it is a
combination of that professional relationship between
the healthcare physician and the company, and it is a
very intricate relationship.
Q76 Stephen Metcalfe: If they are working as

partners, and the registries are collecting data about
how products are performing, whose responsibility is
it to analyse that data? Is that through the registries or
is that then returned to the manufacturer to do that?
Peter Ellingworth: It depends on whose data it is. The
registries clearly are owned by the clinicians, and the
manufacturers will analyse their own data but will be
continually sharing it as there are elements of it from
which to learn. The improvements that are coming or
we hope are coming will certainly be part of that.
Going back to the points that have been made, we will
support the transparency.
Q77 Stephen Metcalfe: Do you think there needs to
be a mandatory element to that? Do you think
clinicians should have to report?
Peter Ellingworth: The National Joint Registry is
now mandatory.
Q78 Stephen Metcalfe: For manufacturers?
Peter Ellingworth: No; for clinicians.
Q79 Stephen Metcalfe: They have to report? There
is no one who is not
Peter Ellingworth: For hospitals. That was changed
very recently.
Q80 Stephen Metcalfe: As I understand it, across the
whole industry there is no formal system for that;
there are good and bad examples, and this is a way of
identifying presumably what is effective?
Peter Ellingworth: Yes, and they need to be
proportionate. If you are dealing with a simple cotton
swab, you would not go through the same process that
you would with respect to a complex implantable
device, but, as ever, there are ways to improve. How
we have got to the great state of the industry with its
high safety record for patients today is by continually
reviewing and looking back to see how we can do
this differently. Any negative incident is, of course,
incredibly regrettable, but you have to balance that
against the number of people who are benefiting and
are pain-free. We talked about hips at the beginning
of this. It has made a significant difference to
peoples lives.
Q81 Graham Stringer: Should there be a central
European registry for all medical devices? Would it
be helpful to have a unique device identification on
all those devices with that information held centrally
in Europe?
Peter Ellingworth: UDI is coming, and we are
actively engaged in that. There are many positive
aspects to that. Mike in fact works in Europe.
Q82 Graham Stringer: What is the schedule for
that?
Mike Kreuzer: Incidentally, I chair a European
industry group that is driving this at the moment. The
schedule for unique device identification is that it will
now be part of the revision; in other words, there will
be a specific clause in the revision to require devices
to carry a unique identifier machine-readable code.
The revision will take up to four or five years to come

fully into force, but a lot of work is being done at the

present time to drive this ahead. I believe it will be of
enormous benefitit is not the complete answerin
setting up new registries. To follow on from the
previous point, this is a fairly uncharted area at the
moment and we do need registries. To come back to
your point about a pan-European one, that would be
an ideal, but it is probably something that would not
be easily achievable. What might or should be
achievable is to have registries that are interoperable.
Q83 Graham Stringer: To follow up on Stephens
question, who should have access to that information?
Peter Ellingworth: Registries today are available and
are transparent.
Mike Kreuzer: Manufacturers, clinicians and
regulators. This is something that needs some
advancement and new design, if you like. We are just

moving into that period now.
Peter Ellingworth: It is certainly a question, again,
for the healthcare professionals. There is a lot of
information in there. To make it available to the
public, there may be some questions about educating
people to understand that information. I suggest that
you talk to them.
Chair: Gentlemen, that has been a very helpful
session. Thank you very much indeed for your
evidence. If you have any other thoughts about some
of the issues that have been raised, including some of
the sensitive questions we asked, we would be grateful
if you would follow that up in writing.
Examination of Witness
Witness: Jacqueline Minor, Director of Consumer Affairs, Directorate-General for Health & Consumers,
European Commission, gave evidence.
Q84 Chair: I welcome you to our session and invite
you to introduce yourself.
Jacqueline Minor: My name is Jacqueline Minor. I
am the director in the Directorate-General for
Health & Consumers of the European Commission
with responsibility for medical devices.
Q85 Chair: Will you start off by giving us a brief
summary of what is happening to the Medical Devices
Directive, and in what time frame you envisage this
matter being resolved?
Jacqueline Minor: As you have probably heard from
a number of previous witnesses, the medical device
regulatory framework in Europe consists of three
directives, the oldest of which was adopted in 1990,
so these directives have been in place for about 20
years. They have been amended fairly consistently on
specific points, but we believe the time has now come
for a more far-reaching revision. We started consulting
broadly on this in 2008. We carried out a further
consultation in 2010, and we have also had ongoing
discussions with stakeholders throughout the last four
to five years about what changes are needed.
We have now got to the point where we are about to
make our proposal. It should be tabled by the
Commission in late September of this year, and then
it will go to the co-legislators, the European
Parliament and Council of Ministers. In the best of all
possible worlds, we would hope for adoption by the
end of 2013. There will be a period of
implementation, so the new regulatory framework will
probably not be in full force until the end of
20142015.
Q86 Chair: Our understanding of the original
directive is that it was all about providing unhindered
access to the European market. Is the balance shifting
from that towards public health in the debates that are
going on?
Jacqueline Minor: The directives have always had
twin objectives: securing the safety of devices and
meeting public health objectives but also securing the

free movement of the product in questionthe
medical devicein Europes internal market. That
will remain the case in the new regulatory framework.
However, over time, there has perhaps been a shift in
the perception of the importance of medical devices
to public safety and health, and a greater awareness
of the need to ensure that public health, and the safety
of patients and other users, are the paramount
concerns in putting together the regulatory framework.
Experience and recent events in particular have shown
us that we can do better, and we want to address a
number of weaknesses.
Q87 Chair: You heard some of the concerns
expressed by previous witnesses. Do you share those
concerns?
Jacqueline Minor: Yes, absolutely.
Q88 Chair: You would want to see issues like
transparency and better controls over some of the 78
notified bodies being incorporated in a directive that
is enforced rigorously across Europe?
Jacqueline Minor: Indeed. The diagnosis, if I may
call it that, of the weaknesses is fairly broadly shared.
Everybody involved in the industry and in regulating
itcompetent authorities across Europeshares a
view as to what needs to be addressed in the revision.
We intend to propose two regulations, so we are going
to move from directives to regulations. That has the
effect of meaning that no national legislation is
required to translate the rules into the legal systems of
the member states, which will eliminate to some
degree differences of interpretation or of application.
We want to address particularly oversight of notified
bodies and their initial designation by competent
authorities in member states, and the way in which
they carry out their conformity assessments. We want
to address transparency, which I noticed was a
recurring theme as I listened to the previous witnesses,
and post-market follow-up and surveillance.

13 June 2012 Jacqueline Minor
Q89 Chair: I have just done some work outside this

Committee on health and safety. I am serving on a
panel that the Government established to review some
of the health and safety legislation in the country. We
were looking at pan-European experience in that
respect. There appear to be differences between
member states in what the law says and its
enforcement. Is this your underlying worry in the case
of medical implants?
Jacqueline Minor: One has to acknowledge that the
rigour of the system always depends upon the
resources, stringency and effort with which national
supervisory authorities in the end exercise their
responsibilities. There is always that issue with
internal market legislation.
Q90 Chair: You are implying that there is a
spectrum.
Jacqueline Minor: There is a spectrum of resource,
competence and size of market, but what we hope to
do in the revision is create greater commonality of
view and shared resource management but also shared
oversight of the system.
Q91 Stephen Metcalfe: In the previous session, I
was concerned about post-market surveillance in light
of some of those inconsistencies. To iron out those
inconsistencies, we need a more standardised
approach. It is a pan-European market and therefore I
imagine we all want the same level of quality
assurance across the whole market. I think you accept
there is a role in that for a central body. Do you see a
role for member countries to help register and judge
each anothers competent authorities and notified
bodies to try to get a level of consistency?
Jacqueline Minor: Certainly, for notified bodies, we
envisage a system where responsibility for designating
a notified body remains with the competent member
state, but prior to that designation there would be a
joint inspection. Whereas currently, as you heard from
the gentleman from BSI, it is the British authorities
who carry out the inspection of BSI before
designating, or confirming its designation, we would
have a system whereby there would be a joint team.
You would have a team from the member state
concerned but that would also include people from
another member state, probably people drawn from a
European list. The team would draw up an inspection
report. That would be submitted to a group of
European experts, who would issue a favourable or
unfavourable opinion, or an opinion with reservations.
That would go back to the competent member state,
which would make a final decision on designation.
One imagines that if there were reservations, or the
report was negative, they would not go ahead with the
designation, and the report would be public, so that
would bring some pressure to bear upon them.
Q92 Stephen Metcalfe: Do you envisage a central
EU committee overseeing that process?
Jacqueline Minor: We are proposing something
called the medical devices expert group, which would
be composed of representatives appointed by member
states, but in their personal capacityeither one or
two from each member state.
Q93 Stephen Metcalfe: Do you see that leading to a

lower number of notified bodies?
Jacqueline Minor: To lower the number of notified
bodies is not an objective in itself, but it might well
be a consequence.
Q94 Stephen Metcalfe: But, if there were a smaller
number, presumably it would make it easier
continually to assess whether those standards are
being maintained?
Jacqueline Minor: Yes, indeed. What we would also
expect to see is that, even if there is not a reduction
in the absolute number of bodies, there might well be
a restriction on their areas of competence, so some of
them would be designated only for a more limited
range of devices.
Q95 Stephen Metcalfe: Presumably, this would add
some additional cost to bringing a product to market?
Jacqueline Minor: Yes.
Q96 Stephen Metcalfe: How do you envisage that
cost being paid for?
Jacqueline Minor: Manufacturers currently pay
notified bodies a fee for the work carried out, and
obviously notified bodies have to cover their
overheads when they charge that fee. Presumably, that
fee would increase as a result. Having talked to the
industry, they feel this is a cost which the industry
must bearwould be willing to bearin order to
improve confidence in the system and restore trust.
Q97 Stephen Metcalfe: You do not see it being such
a prohibitively high cost that it would put off even the
smallest of specialist manufacturers from bringing a
product to market in Europe?
Jacqueline Minor: I honestly do not think so, because
we are talking about a notified body, as you have
heard, which is designated for a number of years. A
number of manufacturers go to them for certificates,
so when it is spread across all the certificates and all
the manufacturers, I do not think it would amount to
a substantial increase.
Q98 Pamela Nash: Do you think that the revisions
to the directives that are going through at the moment
will address co-ordination of post-market surveillance
throughout the UK?
Jacqueline Minor: I hope so. We want to change the
current system from one where incidents are reported
to national authorities and national authorities report
them at a European level, so we have a kind of twostage process, to one where we create a single portal
so every serious incident would be reported directly
at European level. I hope that would enable us to pick
up more quickly any emerging trend that gave concern
in relation to a device. We also hope to make some
funds available to have some central trend analysis,
so that we would have scientists working in our joint
research centre looking at the data coming in and
being able to check it and sound the alarm more
quickly than has been the case in the past.
Q99 Chair: This would be a portal to which
clinicians themselves would have access?

Jacqueline Minor: Clinicians, even patients, but

mainly manufacturers.
Q100 Pamela Nash: If you had to create that single
portal, can you expand a bit on what you see as the
practicalities? Who would set this up? How long
would it take? What would be the costs involved?
Jacqueline Minor: We would set it up. I cannot
remember the exact cost at which we have assessed
it, but we would plan to set it up in the period between
the final adoption of the legislation and its coming
into effect so it would be available when the new
regulatory framework goes live.
Q101 Pamela Nash: Is that information that you
could send us? Could you share that with us?
Q102 Pamela Nash: If an implant is found to be
faulty, in your experience so far, is its withdrawal
from the market consistent across member states at
the moment? How would the new registry be able to
help fix those problems that have been found so far?
Jacqueline Minor: Under the current framework, both
risk assessment and risk management are left in the
hands of member states. A member state determines
what it believes is the risk from a particular product
post-market incident report. It also decides how to
address that risk. Initially, the onus is on the
manufacturer to determine whether they need to
modify or recall their own product, but with a largescale incident, such as the PIP, it was up to each
member state to determine the advice it would give to
the women concerned. What we hope or plan to do
under the new system is move risk analysis to a more
central position: that is, the trend analysis. We will
also make provision for a common risk management,
so in certain cases involving large-scale incidents such
as the PIPmaybe metal on metalwe may also
have a European recommendation as to how that
should be addressed by clinicians, so we will not have
the situation where patients in different countries
Q103 Pamela Nash: Could you explain that a bit
more? Does that mean that individual countries would
still have the power to take a decision based on
information given them from the central registry, or
would rules be implemented that meant that you
would have to have a uniform approach?
Jacqueline Minor: The proposed regulation will give
rise to the possibility of a uniform approach. It will
depend on the nature of the incident, but I would
imagine that for a widespread incident such as the PIP,
we would try to aim at a common European
recommendation as to how it should be addressed.
Q104 Pamela Nash: But the power would still lie
with individual countries to take that decision.
Jacqueline
Minor:
There
would
be
a
recommendation, and I think it would then be difficult
for individual member states to ignore it.
Q105 Pamela Nash: On the question of coordination throughout the EU, do you think there
should also be a policy on healthcare professionals
having to report if they find a fault in the devices they

are using?
Jacqueline Minor: Yes. Currently, the rule is that
manufacturers must report serious incidents. What we
want to do is open up the possibility of healthcare
professionals and patients themselves reporting
incidents. That is not without its difficulties, because
a patient often cannot tell whether the problem is with
the device itself or the care they receive from the
health system. It is difficult to make that obligatory
because of the legal basis on which we work, but we
would certainly encourage a co-ordinated approach.
Q106 Pamela Nash: Is that covered in the directive,
and is it being looked at in the revision?
Jacqueline Minor: It is being looked at. We will try
to have a permissive provision in the regulation, and
when we set up the single portal, we will also try to
ensure that it enables reporting by patients and
healthcare professionals as well as manufacturers. For
healthcare professionals it is easy enough to do; for
patients it is a little more difficult.
Q107 Graham Stringer: Perhaps I may read you a
quote from the Royal College of Physicians: Despite
the lack of hard evidence that the current system of
approving implanted devices for marketing within the
EU, there is concern that the current system of
competent authorities being involved at the clinical
trial approval stage and with post-market vigilance,
but not directly with product approvals, is
unsatisfactory. That leads to the obvious question:
should the expertise of those competent authorities be
used in the initial approval stage?
Jacqueline Minor: This is something that we are
considering in the revision. There are several ways in
which we will address that. The first is that we will
make available to producers and to notified bodies
early scientific advice. We will have a scientific panel,
and anyone developing a novel technology will be
able to go to that scientific panel to ask about the
kinds of evidence they will need to bring forward to
support its safety when the time comes for conformity
assessment and placing it on the market.
The second and perhaps more significant strand that
we are developing is that in future anyone who brings
a new class III device to marketthat is the highest
risk for uswill have to notify their intention
centrally. At that point, competent authorities in all
the member states would learn of something that is
approaching the point at which it will be placed on
the market. Currently, a competent authority does not
know what is coming on to the market until the goods
are there. When that notification is made, it will be
examined by our scientific experts. It could be called
in for something we are labelling the scrutiny
procedure. The file presented by the manufacturer
the design dossier and the clinical evidencecould be
called in and looked at by a central body and our
scientific experts. The scientific opinion would go to
the central committee, the medical device expert
group, and they would offer an opinion as to the
evidence presented, which would then go back to the
notified body. The notified body would have to take
that into account in its final conformity assessment

and its decision as to whether or not to issue a

certificate.
Q108 Graham Stringer: Would it be fair to
characterise ittell me if it is not fairas that, in the
future, you are going to rely on better communications
between the different bodies with the knowledge
rather than actually involving the competent authority
in the approval process itself? Is that a fair way of
putting it?
Jacqueline Minor: No. I think there would be an
involvement of the competent authorities. First, they
would get this prior warning, which they currently do
not. Secondly, the medical device expert group that
we are creating would have an upstream view and
offer an upstream opinion on a device which was
coming new to market before it received its certificate
and was allowed to circulate in the internal market.
What we are not envisaging, which other jurisdictions
apply, is pre-market approval, which is where a
central body has to grant authorisation to a medical
device before it is allowed to go on the market, as
happens, for example, in the US.
Q109 Chair: Are there any other aspects of the
proposed revised directives that we have not discussed
this morning that are relevant?
Jacqueline Minor: You have discussed it, but I would
like to emphasise transparency, which is very
important. It is very difficult, as I think a number of
your earlier questions pointed out, for anyone to know
what devices are on the market; what evidence was
used to support their safety; and what information is
available about the associated risks and the incidents
they might have provoked. We are planning to have a
central registry in which all manufacturers and all
devices will have to be listed. For each device, there
will be some standard information, such as the name
of the notified bodies, the class of risk, and the unique
device identifier, when we have that. There will also
be a summary of performance and clinical data. For
the first time, for example, clinicians will be able to
have access to the clinical data which supported the
certificate granted to the device.
Q110 Chair: You have no doubt in your mind that
that information ought to be available to both the
clinician and patient?
Jacqueline Minor: It is a summary; it is not the full
technical file, but we believe it should be made
available.
Q111 Roger Williams: I was going to ask whether
the information was made available to the patient.
Some clinicians will use only specific products. How
does that leave the patient if they have made up their
mind that a particular product is the one that will give
them the best relief and the particular doctor does not
supply it, or does not do it?
Jacqueline Minor: To some extent, that goes beyond
the ambit of the regulation of the product. That is a
question about the healthcare system offering the
patient choices and informed consent, of the doctor in
trying to explain to the patient why they are using a
particular devicein the same way as why they
recommend a particular drugbut we know from our

broader discussions with stakeholders that the role of
the patient is changing. There is a belief and
expectation that they have a far greater role in the
management of their condition and a far greater say
in the therapy applied to it. In line with that trend, I
would expect this data to be useful, maybe not so
much to individual patients, but you could imagine
that associations of patients with a particular condition
would offer guidance about the choice between
different devices.
Q112 Stephen Metcalfe: You said that this register
would hold information on all medical devices. For
clarity, you do not mean just class IIB and III; you
mean all of them?
Jacqueline Minor: Yes, although the details for all
classes would differ of course.
Q113 Stephen Metcalfe: That means there will be
many thousands of items on it?
Q114 Stephen Metcalfe: Would the cost of that be
covered by the industry itself?
Jacqueline Minor: There would probably be a fee for
registration, but what industry is looking at at present
is the possibility of having to register 27 times,
because a number of member states have set up
registries. They are perfectly entitled to do that under
existing legislation. Either they charge a fee or, if they
do not, there is the administrative burden of having to
go through the registration process in each member
state.
Q115 Stephen Metcalfe: For a product that is
available across the whole of Europe, it could reduce
costs.
Jacqueline Minor: It could certainly reduce burden
and, one hopes, consequently costs.
Q116 Stephen Metcalfe: We are talking about
covering things like sticky tape, bandages, rubber
gloves and plasters.
Q117 Chair: A final question: I recognise issues to
do with protocols in the Brussels machine, but I
suspect we are the only group of parliamentarians
across the whole of Europe looking in such detail at
this.
Jacqueline Minor: The French Senate is doing so.
Q118 Chair: Excellent. It would be extremely
helpful, if you are able to do it, if you would provide
us in confidence with a draft of the thinking, with
obvious caveats that we would respect the necessary
protocols. I think it would mutually help the thinking
in this very important area.
Jacqueline Minor: I cannot give you a positive yes
to that now; it is something I would have to refer to
higher authorities.
Q119 Chair: Even if it was a summary. You have
given us a summary already, in a sense.

Jacqueline Minor: What is your time scale? There

are certain procedural steps we are going through and
it might be easier to do it at a slightly later stage.
Q120 Chair: It would be helpful if we had something
before September.
Jacqueline Minor: Before September? I will do my
best.
Jacqueline Minor: Absolutely.

Chair: We are extremely grateful to you for spending
time with us this morning. Thank you very much for
being so open with us.
We now move on to our third panel. The Minister and
Sir Kent Woods will be joining us.
Q121 Chair: You understand that it is all in aid of

transparency.
Witnesses: Sir Kent Woods, Chief Executive, Medicines and Healthcare products Regulatory Agency
(MHRA), and Earl Howe, Parliamentary Under-Secretary of State, Department of Health, gave evidence.
Q122 Chair: Minister, welcome to you and thank
you for agreeing to come to see us today. Sir Kent,
I would be grateful if you would formally introduce
yourself to the Committee.
Sir Kent Woods: I am Kent Woods, chief executive of
the Medicines and Healthcare products Regulatory
Agency.
Q123 Chair: We have heard some fascinating
evidence on this issue. Minister, in what areas of the
revised directive have the Department and, to you, Sir
Kent, the MHRA been most heavily involved, and
what are your priorities?
Earl Howe: Sir Kent can probably fill out the detail,
but the Commission have already given us an
indication of where they think the focus should lie in
terms of revising the directives. Undoubtedly, there
needs to be greater focus on ensuring that notified
bodies are fit for purpose. There is a perception of a
variation in the performance of notified bodies across
the European Union. I am glad to say we do not have
any worries about the ones in the UK, but there is a
need to ensure that notified bodies are performing as
they should and have the right expertise to address the
areas with which they are concerned.
Subsequent post-market surveillance undertaken by
manufacturers is an area to be looked at. We want to
ensure that EU competent authorities co-operate and
co-ordinate their post-market surveillance activities.
Sir Kent can probably flesh out some of that usefully.
Sir Kent Woods: Our starting point when we were
thinking as an agency about the revision of the
directives was to reflect that pharmaceuticals and
medical devices are fundamentally different, and the
way they are regulated needs properly to reflect those
differences. As regards medical devices, the areas in
which they differ are, first, the way they are innovated.
They are innovated in a rather iterative way with
progressive, relatively small changes in technology
and refinement, perhaps as frequently as every year or
two, which is quite unlike the situation with
pharmaceuticals.
The second point is about their sheer multiplicity.
When we look at pharmaceuticals we are talking
about the low thousands; when we look at medical
devices we are looking at hundreds of thousands in
the EU. Therefore, the regulatory system has to be

able to cope with that.
The third and perhaps most important difference is the
way in which they fail when they give rise to
problems. In contrast to pharmaceuticals, the areas
where medical devices give us problems are, first, in
relation to sporadic manufacturing problems, which
are not easily picked up at the market authorisation
step; and, secondly, particularly in terms of
implantable devices, the way they wear over time, and
all of them will over time. Again, that is on a time
scale that is not easy to pick up in pre-clinical studies.
The other aspect of the failure pattern of medical
devices is the much greater involvement of the
operator factorin other words, the way they are used
and the way patients are selected for particular
devices.
The regulatory system we wish to see for medical
devices has to accommodate these rather distinctive
characteristics. Our view has been that, in principle,
the Medical Devices Directives under the new
approach are appropriate, but in detail, as you have
heard from the Minister, there are areas where we
would wish to see a greater degree of consistency of
application and rigour across the piece in certain
areas. At the centre of this has to be the designation
and the performance of the notified bodies because of
the fact that in Europe we are essentially working on
a mutual recognition system. A notified body can
award a CE mark in any country of Europethere are
70 or 80 notified bodiesand that gives access to the
entire European market. Clearly, the performance of
notified bodies is central to the integrity of the system.
Going back to what I said earlier about the distinctive
features of medical devices, the balance has to be right
between the pre-market assessment of the device
what one can learn before it goes into useand the
post-market evaluation, which requires a high degree
of vigilance, market surveillance and the best possible
means of monitoring outcomes under conditions of
use, and feeding that back both to clinicians and
manufacturers.
Q124 Chair: I take it you would agree that, if one
saw a product being questioned or refused by BSI, for
example, and it went off and got approval from

13 June 2012 Sir Kent Woods and Earl Howe
another notified body, that is a pretty unsatisfactory

situation?
Sir Kent Woods: Indeed.
Q125 Chair: That process at the very least ought to
be totally transparent.
Sir Kent Woods: Indeed. You have touched on an
issue we take very seriously for the revision, which is
this question of transparency. Criticism has rightly
been made that under the existing arrangements, and
it is in the Medical Devices Directives, there are
obligations of confidentiality on those who run the
system. We find this frustrating and unhelpful, and I
think the general public and health professions would
wish to be able to see more of the evidence
underpinning, for instance, the award of a CE mark,
and evidence emerging from post-market surveillance,
and all this can be incorporated into the revision of
the directives.
Q126 Stephen Metcalfe: Are there any proposed
changes that you do not agree with and are not in step
with the way we do things at the moment?
Sir Kent Woods: We have not yet seen in detail the
proposals. I have been in close contact with the
Commission as these ideas have been developed. For
me, one of the most important issues was to avoid
going in a direction that placed a very large additional
burden on the pre-market authorisation step. My
reason for saying that is partly because there is this
iterative process of product development, which is
difficult to evaluate in depth pre-market, and also
because we know, from the experience of the United
States, that going down that route very much increases
the time delay of giving patients access to new
technologies. There is a balance to be struck clearly
between speed of access to new technologies and the
degree of protection of patients, but we would wish to
seeI think the revisions will address thisa greater
strengthening of the post-market surveillance process,
but also in detail an improvement in the way the
notified bodies confer CE marks.
Q127 Stephen Metcalfe: From what you understand,
you think the balance is probably about right.
Sir Kent Woods: I think that is right.
Q128 Chair: I want to pursue this a little more. Last
night Mr Mosley and I heard a very interesting
presentation about the work going on by our
colleagues in the Home Office to bring up to date the
directive covering experiments on animals. These
discussions and debates are tortuously difficult, and
making sure that we end up not harmonising down to
a lower common denominator than the public would
expect us to do is very difficult. We recognise in this
case that the evidence we have had suggests that some
of the notified bodies are not as rigorous and effective
as our own. Earl Howe, if the outcome was the right
level of regulation but it was more centralised within
the European machinery, would that create problems
for you?
Earl Howe: It would be likely to result in a more
costly system, because you would have to populate
whatever European body was charged with this job
with the right experts. We would prefer to see a model

involving much more efficient co-operation between
member states. To come back to what Sir Kent said
on transparency, this was a point that ran through my
own report on PIP implants. If there was one
expression that summarised my recommendations on
that, it was greater transparency. If we can get
greater sharing of data between member states, maybe
even have an EU portal where data can be fed in when
there is an adverse report on a device so that it is
clearly on view to all member states, that would be
much more efficient and effective and much less
cumbersome.
Q129 Chair: A portal that included good as well as
adverse information?
Earl Howe: Yes. Why not?
Q130 Chair: You would prefer that kind of European
co-ordination rather than a new body?
Earl Howe: Yes, I would. Reading the opinion and
talking to medical devices companies, that is what
they would say they would prefer, largely because
they fear that a centralised European mechanism could
act as a brake on innovation and add to costs
unnecessarily.
Q131 Chair: Has your thinking on this been affected
by your experience of dealing with the metal-on-metal
hip joints and PIP?
Earl Howe: Yes, undoubtedly. One of the lessons of
the metal-on-metal hip joints can be drawn by making
a comparison between the situation in this country and
in the United States. What we have in this country is
a regulatora competent authority in the shape of the
MHRAthat has very close, active links with the
professions, royal colleges and experts of all kinds so
that early intelligence is available on any problems in
medical devices. We have seen with metal-on-metal
hip joints a dramatic drop in their use of ever since it
was first suspected that there might be a problem with
them. That is not the case in the United States. I think
the latest figures in my brief are that in this country
60,000 or 70,000 joint replacement operations go on
in a year, of which 2% are metal-on-metal at the
moment, and dwindling. In America it is 35%,
because in the United States their post-market
surveillance is much weaker than in this country. It is
a case of being able to react swiftly, as Sir Kent has
said, in the face of any problems while also ensuring
that new technology is available swiftly to patients,
and that many of our medtech companies, SMEs
mainly, are able to start up and get going in a way that
does not present them with unreasonable regulatory
burdens at the outset.
Q132 Gareth Johnson: Perhaps I can ask you some
more general questions about the MHRA. In
particular, where does the MHRA get its expertise
from? I understand that you have a Committee on the
Safety of Devices. How important is that in providing
the MHRA with the expertise it needs?
Sir Kent Woods: Thank you for the question. We have
in-house 104 staff working on medical devices
regulation at the moment, and of those about 60 are

specialists; they are scientists, engineers, technical in

their background. Because of the enormous scope of
medical devices technology we must draw extensively
on external expertise, not only to provide us with
scientific and technical knowledge about the devices
themselves but to provide that sort of clinical interface
so that we are aware of issues arising in clinical
practice.
We have several ways of doing this. As you mention,
we have a Committee on the Safety of Devices which
has been in existence for nearly 10 years. This is a
group of 25 external experts from clinical and
scientific disciplines, who meet regularly. We take to
them issues of general principle, and where we have
a concern about a specific area of technology usually
there will be somebody on that committee who can
lead us in to the relevant expertise externally.
We have a wider panel of experts whom we consult
on an ad hoc basis, depending on the nature of the
problem, and we also have very strong links with the
professional bodies. If we take the metal-on-metal hip
incident and the investigations we have done on it, we
have worked very closely with the British Orthopaedic
Association and British Hip Society, and the guidance
we have put out has been jointly between the clinical
professional bodies and the regulator, drawing on the
expertise of both. That interface with experts and
clinicians in the field makes a huge difference to the
way we do our business.
Q133 Gareth Johnson: I get the impression that you
are quite a private organisation, if I may put it that
way. You publicly state that the work of the committee
must remain confidential at all times. Is that purely
for commercial reasons, or is there any other reason
why that is the case? Is it possible that that committee
could be a little more open?
Sir Kent Woods: It goes back to what I said earlier
about the obligations placed on us by the Medical
Devices Directives. I think article 20 of the main
directive requires that information obtained by
regulators is confidential. I would like to see that
changed. In the revised legislation I would like to see
that the default assumption is transparency rather than
confidentiality. That has really somewhat set the tone
for the way in which we regulate medical devices. To
an extent the same thing has happened in our
pharmaceutical regulation. The Medicines Act 1968
again imposed a legal obligation of confidentiality,
which has changed. I think we are seeing that process
happening also on the medical devices front.
Q134 Gareth Johnson: That is quite interesting. If
there was a change, what aspects of the work that you
do at the moment that you currently keep confidential
do you think you could put in the public domain?
Sir Kent Woods: For instance, with pharmaceuticals
we put into the public domain routinely tabulated
analyses of the adverse drug reaction reports we have
received on all the medicines we regulate. That data
is there; you can look at it on our website. Although
we have to hedge it around with cautions about how
it can be interpreted, none the less the information
is there.
On the medical devices side, to be able to give greater

public visibility to accumulating experience would be
valuable. Going back to the metal-on-metal casethis
is a really instructive issuein the UK we have the
National Joint Registry. It is not within the MHRA,
but we are closely involved in it and have
representation on it. The National Joint Registry is the
biggest in the world now. It has over a million hip,
knee and ankle replacements in its register, and it
produces an annual report, which sets out in very great
detail the follow-up results of those procedures by
type of operation, type of device and manufacturer of
device. That is a valuable resource for changing
clinical practice. That is the way in which
accumulating information on outcome is fed back to
improving care and, therefore, improving outcomes.
Fundamentally, that is what regulation is about.
Regulation is not about standing as policeman over
the industry; our motivation is to make sure that the
end results in terms of clinical care are the optimum.
So the transparency that now exists around the
outcomes of joint replacement surgery through the
National Joint Registry is a model of what might be
achieved in other areas were there to be better followup data presented in a more coherent and consistent
way.
Q135 Gareth Johnson: Do you ever privately share
information with any other competent authorities?
Sir Kent Woods: Yes, indeed.
Q136 Gareth Johnson: Can you give any examples
of that?
Sir Kent Woods: We have an obligation to notify
competent authorities if we hear of serious adverse
incidents that might affect products on the market in
the other countries of Europe. There is that
communication. I do not think in practice it is as
regular and detailed as it could be. One of the aspects
of the legislative review has been how to improve the
interaction between the national competent authorities
across the 27 member states. As you might expect,
some of the national competent authorities are larger;
they have better resources and more data, but we are
dealing in a European system and it is important that
we draw on experience from the whole population of
500 million and share our resources. We have been
exploring among ourselves as heads of the national
competent authorities how best to do this. I am sure
there will be progress within the next months and
years in further formalising the interactions between
the national authorities.
Q137 Sarah Newton: I would like to pick up the
very welcome comments you made that the key way
forward is improved transparency. This has come out
very strongly from all our witnesses, but I would like
to move on to transparency in the process of how you
go about selecting the notified bodies and the notified
bodies themselves. We have heard a lot of criticism,
especially from clinicians and the royal colleges,
about the lack of transparency in the pre-approval
process. Why is there not more transparency in the
process?

Sir Kent Woods: There are probably two subsets to

that question. One is transparency about how notified
bodies are designated and how we audit their
capabilities over time. The other bit is about how the
notified bodies assess products that are brought to
them, how they evaluate the design dossiers and how
they evaluate the company quality systems with which
they are faced. As I touched on earlier, the relative
lack of transparency dates from the original
legislation, which has seen much of this as being
commercially
confidential
information,
but
expectations change and this is information that will
influence the way clinicians do their jobs; it will
influence the way patients make decisions about
healthcare. I think we have seen a shift in social
expectations over the years, which means that we
must explore every opportunity to get that information
into the public domain, with some protections
remaining for what is genuinely commercial in
confidence and for data protection purposes down to
the level of individual patient outcomes. Those clearly
are the red line areas that we have to protect, but the
definition of what constitutes commercial in
confidence is something that exercises us constantly
across the whole area of regulation of medical
devices, pharmaceuticalsthe lot.
Q138 Sarah Newton: I think we have been reassured
this morning by the consistent determination from you
but also from industry as a result of the current review
of the directives to have greater transparency.
However, I was rather concerned by the evidence we
heard from the person representing the Commission
that the changes were not going to be to the directives,
which would give this Parliament an opportunity to
scrutinise them, but to regulations, so there would not
be an opportunity for us to scrutinise them. If we
assume, probably because we are very patriotic, that
we are doing things really well in the UK, perhaps
better than a lot of other member states, how can we
be assured that in these new regulations we are not
going to have a reduction in standards compared with
our own, because we are not going to have the
opportunity as a Parliament to debate and accept our
own interpretation of the directive?
Earl Howe: I am awareSir Kent can perhaps
confirm thisthat the Commission are equally
concerned that there should be a levelling up in the
quality of notified bodies, and that the process of
designation and audit should not be up to just one
competent authority but it should involve joint
assessment teams comprised of experts from more
than one member state and, indeed, the Commission,
this being overseen by a central EU committee. Those
are the kinds of noises we are getting at the moment.
I think we should be reassured by that. Whether that
is the precise formula we arrive at eventually we do
not know, but clearly there is an awareness at
Commission level that the point you make is a very
valid one.
Sir Kent Woods: The distinction between directive
and regulation has two sides to it. On the one hand, I
think the motivation is to achieve consistency across
Europe, and the theory would be that a regulation
would do that more reliably than a directive, on the
grounds that a directive has a transposition step where

there may be variations that allow excellence to
flourish in one part of Europe but may allow the
opposite to happen. It is even more important,
therefore, that, if there is to be a regulation, the input
from the more active member states is very forceful
in making clear what the essential requirements of that
regulation should be.
As far as transparency goes, everything I hear
suggests that there will be a fundamental shift to a
more permissive approach to the use of data, whereas
what we have at the moment in the directives is a very
restrictive legal basis around the use of data. Provided
we have that permissive framework, I think member
states have the ability to use their best judgment as to
how that is done.
Q139 Chair: You regard that point as nonnegotiable; it is a top priority.
Sir Kent Woods: The issue of transparency
absolutely.
Q140 Chair: Minister, do you confirm that on behalf
of the Government?
Earl Howe: I am absolutely behind this. All the
lessons of history tell us that we need to make a
fundamental shift in the direction of transparency and
away from unnecessary confidentiality. There may be
some confidentiality that needs to remain, but the
presumption is far too heavily weighted in the wrong
direction at the moment.
Q141 Sarah Newton: I want to put one question that
came up a few times in the evidence of our witnesses
this morning. If a notified body rejected an applicant,
they would go to another notified body and somehow
get approval. What do you do when you find that has
occurred? I understand it is quite rare, but the fact it
is going on causes us a lot of concern. What do you
do with that information when you receive it?
Sir Kent Woods: We have had anecdotal accounts of
this, but it is terribly difficult to get the data, partly
because we have a system of 70 or 80 notified bodies
across the EU. There is no reliable way of detecting
that to the extent that one can say it is not happening.
The anecdotes have certainly circulated. I think that is
a potential weakness. Whether it is a real weakness I
am not sure. I think the solution comes back to the
future arrangements for designating and auditing
notified bodies. If we genuinely are able to achieve on
a multinational basis a consistent standard of
designation and audit, the incentives for forum
shopping will not be there. It may be that we end
up with fewer notified bodies, but we must have a
consistency of performance of notified bodies. If we
have that, the problem of forum shopping is not a
worry.
Earl Howe: There is also a case for specifying in
greater detail how notified bodies should undertake
conformity assessments and ongoing monitoring of
manufacturers, and the use of unannounced
inspections and audits, perhaps requiring physical
checks of devices. I know this takes us into the
territory of greater prescription, but perhaps there is a
case for looking at that more closely if we really want

to see greater consistency of performance across

Europe.
Q142 Graham Stringer: Patients and politicians
always want the best of both worlds. Patients want
medical devices to be 100% safe. If they are going to
save lives or improve the quality of life, they also
want them now rather than in two years. How do you
balance those competing demands, Sir Kent? We
heard evidence from Professor Westerby a few weeks
ago that people were moving to Greece because they
could use devices to help with heart problems there
now that we cannot not use in this country. How do
you balance those issues?
Sir Kent Woods: You are absolutely right. There is
always a balance to be struck. As a regulatory agency,
we are firmly of the view that innovation is a positive
contributor to public health, and therefore to the extent
we can do so without endangering clinical outcomes
we should enable it. That is one of the reasons why I
think the existing broad approach to medical devices
is right, because the innovation happens in small
incremental steps. But the corollary of that to protect
the interests of the patients who receive implants is
the obligation to make sure there is real, accurate and
timely monitoring of outcomes. We are moving quite
quickly to a situation where that is technically much
easier to achieve. The introduction of IT systems into
healthcare and the ability to capture and process large
amounts of data gives us huge potential to make sure
that outcome monitoring, and indeed traceability if
necessary, is achieved much more consistently. But it
requires partnership working between the active
participantsthe regulator working with the industry,
the notified bodies and the clinical community to
make this happen. The capture of event and outcome
data fundamentally rests with the clinicians and to
some extent with patients. We all depend on that
happening, which is why these good working relations
that we have with the clinical community are so
important to us.
Earl Howe: Sir Kent said earlier that it was less a
case of amending the structure of the legislation than
making sure that the regulations work as intended and
as they should. What that implies in the context of
your question is looking at the legal underpinning of
all this in relation to the relative risk of different types
of medical device. What we have is an intent at least
to ensure that the pre-market data that a regulator or
a notified body receives is commensurate with the risk
associated with the innovation or change.
We can take that only so far, because, as Sir Kent said
at the beginning, it would be lovely to be able to
predict the likelihood of failure of a device in
pre-market studies, but it is totally impracticable to do
that. Even if one were to try to do it, it would be so
onerous that the product would probably be unable to
complete the development process. It is important to
achieve that balance between pre-market and postmarket processes so that innovation can proceed so as
to benefit patients while maximising the ability to act
quickly if any problems materialise.
Q143 Graham Stringer: I realise this is a difficult
question to answer because we are dealing with
averages and very different devices. Is pre-market

approval likely to get more expensive and take a
longer or shorter time as you try to balance those two
things? In which direction are we moving? Is it going
to get more expensive and burdensome in a regulatory
way, or can we do it more quickly?
Sir Kent Woods: We can certainly continue to do it
quite quickly, but it is likely that for the more highrisk devices, particularly implanted ones, there will be
an increased cost of doing more clinical studies premarket authorisation, but, as I was suggesting earlier,
we should not allow that to become so burdensome
that it shuts off the innovation process. There are
equally importantin fact more importantways of
learning more about the overall effect of devices in
terms of benefit and harm from the more systematic
interrogation of what happens after it goes on the
market. We can learn a great deal at relatively low
cost by using the information systems we have in a
joined-up way, whereas, if you were to focus the effort
on insisting, for instance, that there were randomised
clinical trials of every device going out to the premarket approval process, first, it would become
unworkable; secondly, it would become fiendishly
expensive; and, thirdly, there would not be a flow of
innovative devices because it just could not be made
to function.
In terms of a trade-off between a system that is
expensive and one that protects patients and is optimal
for patient benefit, I think the right direction to travel
is to strengthen the system as it is but particularly in
relation to the use of registry-type data for longerterm outcome. Of course, that ought to be part of good
practice anyway. If you are studying the outcomes of
a procedure, you want to know it anyway. The fact
that there is a device integral to that procedure is just
a special case.
Q144 Graham Stringer: The problems about
authorising devices do not stop at the boundaries of
the European Union. The equivalent European Union
institution that deals with drugs has come to
agreements with European countries on the immediate
boundaries of Europe. Tell us what is happening
because I do not know. Is it possible to come to
agreements with the Norways, Switzerlands and
Ukraines of this world so that regulation applies to
more than just the EU?
Sir Kent Woods: I think there are two parts to that.
One is the formal arrangements. For instance, Turkey,
although not in the European Union, does have
notified bodies. That is an exceptional situation and is
driven by considerations of the single market. But
there is a wider question about products being
manufactured outside the EU and coming into the EU.
How do we achieve a consistent standard of
conformity? The requirement is that they have to get
a CE mark and do that by the same process as if they
are manufactured in the UK or anywhere else.
A deeper layer to that is that we are looking at an
increasingly globalised world. We have seen very
strongly on the pharmaceutical side that manufacture,
research and development are global activities, and to
think even in terms of the European Union as if it
was a completely self-contained system is no longer

appropriate. As an agency, we have been very active

in the last four or five years in developing good
relationships with the regulatory authorities in China,
Singapore, north America and Australasia. Our
international strategy is driven by two considerations.
First, where are our major lines of supply starting
from? Therefore, we have to be concerned about the
quality of manufacture in those places. I am thinking
particularly of pharmaceuticals. Secondly, globally
regulators need to work together to think through
these problems because they are the same problems
round the world. If we are regulating globalised
industries, regulators have to think globally, and that
is a trend I have seen very strongly in the last few
years.
Q145 Stephen Mosley: Following on from that, one
thing that interested me a few weeks ago when
Professor Westerby was here was that he said that
NHS rationed life-saving technology in a way that
many more lives are lost through that than by devices
going down. Do you have any guidelines as to the
acceptable failure rate? If you have a device that is
going to save someones life but is not going to be
100% perfect over a period of time, do you have any
criteria you use by which you say, Its better to save
someones life now than run the risk of it going wrong
in five years? Are there any guidelines or figures on
that?
Sir Kent Woods: There is a general principle that we
use throughout the agency around risk-based
regulation. In other words, rather than having arbitrary
rules that we apply across the piece, in every case you
have to consider the risks and the potential benefits
of alternative approaches: this medicine against that
medicine; this medicine against no medicine; a
medical device against no medical device. Depending
on the underlying condition in the population you are
treating, that judgment has to be made every time.
It is striking that, if we look at the totality of adverse
incident reports that come in every yearwe get
about 10,000 or 12,000 reports, which we analyse in
various waysa consistent feature is the significance
of operator factors. The way devices are being used
will be a determinant of the outcome in about a third,
we reckon, of these adverse incidents. It raises a
question as to our responsibility not just in informing
the world outside about the risks and benefits of
medical devices but how to use medical devices. We
have put out training materials in relation to infusion
pumps and a whole range of commonly used devices;
we have put out information to patients who are
considering breast implants and all that sort of thing.
These are essentially educational activities that do not
fall within our legal remit, but we think that in terms
of improving health outcomes they are important for
us to do, and we feel that we are quite well sighted to
do it.
Q146 Stephen Mosley: We have heard some very
positive comments this morning about the National
Joint Registry. Aside from joints, in the other areas
that you cover, we have been led to believe there is
less of a formal reporting system. Do you think this
leads to under-reporting of problems with implants?
Sir Kent Woods: Yes. I think under-reporting runs

across all areas of regulated medical products. In
many ways the National Joint Registry teaches us
lessons that we can roll out to other areas. First, the
component parts of a good registry are that it has
strong professional leadership. This is not something
that the regulator imposes on an unwilling world; this
is professionally driven, as indeed the NJR has been
from the outset. Secondly, you need to achieve
consistently high data input and make sure that
procedures and the details of devices are routinely and
accurately captured. That may seem a terribly simple
thing, but the whole system depends on it. Thirdly,
you have to think about how the database is to be
interrogated, by whom and how often.
Those are the standard questions you ask whenever
you are trying to set up a registry. I personally believe
that registries have huge potential. We tried, as you
may know, in the 1990s to set up a breast implant
registry and it failed. It had Government funding, and
after a dozen years it had to be discontinued because,
first, the completeness of registration was totally
inadequate, and, secondly, the willingness of
patientsthe women concernedto give follow-up
information was far too low to allow conclusions to
be drawn. That is a contrast, if you like. It was a
registry that failed compared with the joint registry
that succeeded. Going forward we have to learn those
lessons. I think the key issue for me, certainly within
the NHS, is to make sure that the data are captured at
the time the procedure is done. The key to that would
be to have a unique device identifier so that there is a
recognised code that describes a device. That is
something that is very much in the Commissions
thinking for the revision of the directives.
Earl Howe: That is very important. I would only add
to what Sir Kent has said that the experience of the
National Joint Registry clearly shows the benefits that
registries can bring to post-market surveillance. We
talked about the issue of metal-on-metal hips, and the
problems in that area were first identified and acted
on because of the data emerging from the National
Joint Registry. Before we start to get too enthusiastic
about extending registries to all implantable devices,
there is a lesson to be learned from the breast implant
example, but we also need to bear in mind that these
registries are not cheap to maintain. The National
Joint Registry costs about 3 million a year. One
could compare that with the 10 million spent on the
whole of the MHRAs devices-related work. That is
why I have asked Sir Bruce Keogh in his review of
the regulation of cosmetic interventions to consider
the pros and cons of registries for all implantable
devices. I think there are a number of complex issues
at play here.
Q147 Stephen Mosley: A slightly different approach
might be to look at the yellow card system that is used
for pharmaceutical products. Do you think that might
work with implants?
Sir Kent Woods: We have done two things to make it
easier to report adverse incidents related to medical
devices. We have created an IT system that makes it
easier for manufacturers to deliver the reports to us
which they hear about, but, for patient and clinician

reporting, if you go to the MHRA website, in the

middle of the home page there is a button about
medical device adverse incident reports. That will take
you into an electronic reporting system that can be
used by clinicians, patients or whoever, and will go
straight into our database and be analysed. We also
have electronic yellow card reporting now, too. In
terms of opening up the accessibility of reporting to
patients and healthcare professionals, we have done
both of those, but they are still spontaneous reporting
systems. They complement but do not replace the
need for systematic analysis of outcomes.
Q148 Stephen Mosley: After PIP and metal-onmetal hip replacements, do you think the systems are
now in place to prevent another faulty implant being
used so many times after problems have been
detected?
Earl Howe: On the PIP implant issue, we must always
remember that we are dealing there with a clear case
of fraud. It was clear from my investigation that no
amount of regulation could have prevented deliberate
fraud of that kind. There is no criticism of the notified
body in relation to the PIP manufacturer; they did
their job as far as we can see perfectly adequately, but
the manufacturer was out to hoodwink everybody.
Prior to that finding becoming public, the MHRAs
focus was very much on trying to find out whether
there was a higher than expected rupture rate in PIP
implants. There is a catalogue at the back of my report
of what was done when, and there is no doubt they
followed up rigorously and very conscientiously every
report they got in an endeavour to get to the bottom
of this. I have no criticism on that front.
In the metal-on-metal example, it is probably a good
news story for the reasons that I gave earlier. In this
country we were able to react very swiftly with the

medical community to influence clinical practice
when concerns became apparent.
Sir Kent Woods: It will inevitably be the case as you
improve post-market vigilance systems that you will
find that some products perform below average and
some above. The way the clinical community and, if
necessary, the regulator responds to that is very
important, but we cannot get round the fact that the
systems are there to detect the less well-performing
devices and to take action accordingly. There are some
really interesting lessons we can draw from PIP and
metal-on-metal hips, but they are totally different
ones. As you have heard from the Minister, with PIPs
there is no regulatory framework that is immune to
being subverted. In relation to metal-on-metal, if you
have a good registration and monitoring system, you
will find there are some that are outliers in the wrong
direction, and the speed with which you pick that up
and practice and regulation respond to that is the
hallmark of the quality of the regulatory system.
Chair: Minister and Sir Kent, thank you very much
for an informative session. We look forward to seeing
you batting in the debate over the directive. We are
confident that there is a strong body of opinion inside
the UK, including from patients, that, first, we want
to see more transparency; secondly, we want to see
British industry succeed in this field because we have
some incredibly good businesses in the UK; and,
thirdly, as a corollary to that, we want a regulatory
system that is not so burdensome that it squeezes them
out, especially in those small, very specialist areas. At
the same time, there is a very difficult balance to
achieve, and we wish you well in your negotiations.
Thank you for coming today.
cobber Pack: U PL: COE1 [SE]

Source: /MILES/PKU/INPUT/023414/023414_w008_odeth_PMI 08a - Association of British Healthcare Industries (supplementary).xml
Written evidence
Written evidence submitted by the Medicines and Healthcare products Regulatory Agency
Summary
1. The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for the oversight of
medical devices regulation in the UK, the framework for which is set by European legislation. The regulatory
system for medical devices, of which medical implants are a subset, has operated effectively for the period
that it has been in place and the MHRA does not believe that fundamental change is required. However, there
are aspects of the system that could be strengthened and the forthcoming revision of the Medical Devices
Directives provides an opportunity to address these.
ContextRegulation of Medical Devices
2. Medical implants are regulated in the UK under a broader framework of regulation covering medical
devices. Legislation in the UK (in the form of the Medical Devices Regulations 20021) stems from three
main European Directives:
(a) Directive 90/385/EEC on active implantable medical devices (AIMDD);
(b) Directive 93/42/EEC on medical devices (MDD); and
(c) Directive 98/79/EC on in vitro diagnostic medical devices (IVDD).2
3. The Directives have a dual objective: firstly, to provide manufacturers with a single set of regulatory
requirements that, once met, provide free and unhindered access to the EU market and secondly, to provide
users of medical devices and patients a high level of confidence that devices, when used in accordance with
the manufacturers instructions, are acceptably safe and perform as claimed.
4. The Directives set out a list of essential requirements which all devices must meet before being placed
on the market, as well as imposing various other regulatory requirements upon the manufacturer. The essential
requirements concern matters such as the safety and performance of the device and the amount and type of
information given to the user of the device by way of the label and instructions for use.
5. Under the MDD, devices are placed into four categories according to riskclasses I, IIa, IIb and III
where class I is the lowest and class III the highest risk. A manufacturer of class I devices can self-certify
conformity with the essential requirements, whereas all other devices will require assessment by an independent
third-party organisation, known as a Notified Body, of which there are around 80 across Europe.3 A
manufacturer can select any Notified Body across Europe irrespective of location, provided that their field of
expertise covers the device being considered.
6. There are various options set out within the Directives which a manufacturer may choose to demonstrate
compliance with the essential requirements to a Notified Body, termed conformity assessment. These will
involve, broadly, an assessment of the manufacturers quality control systems, manufacturing processes, or
individual testing of each device type. The aim is to match the level of control of the deviceand thus the
depth and challenge of the conformity assessment procedure adoptedto the perceived risk associated with
the product.
7. Once a device has been demonstrated to meet the essential requirements, a manufacturer places a CE
mark on the device and is free to place the device on the market in all EU countries without further controls.
8. The overarching legislative framework for medical devices is part of the EUs New Legislative
Framework4 (formerly known as the New Approach), which is concerned with facilitating operation of
the single market in various areas of product legislation. The principles of CE marking are common across a
number of sectors; they are used, for example, in relation to the safety of toys and personal protective
equipment, although the standards involved vary substantially from sector to sector.
9. The Directives are implemented and overseen by a competent authority in each EU Member State; in the
UK this is the MHRA. Broadly speaking, the role of the competent authority is to implement the provisions
of the Directives, to appoint and control Notified Bodies, to assess and authorise clinical investigations of nonCE marked devices and to monitor and investigate adverse events and field safety corrective actions (including
recalls) occurring in their country.5
10. These general principles are explored in further detail in relation to medical implants in the following
section.
1
2
3
4
http://www.legislation.gov.uk/uksi/2002/618/contents/made
http://ec.europa.eu/health/medical-devices/documents/index_en.htm
http://ec.europa.eu/enterprise/newapproach/nando/index.cfm?fuseaction=directive.main
http://ec.europa.eu/enterprise/policies/single-market-goods/regulatory-policies-common-rules-for-products/new-legislativeframework/
http://www.mhra.gov.uk/Howweregulate/Devices/index.htm

Regulation of Medical Implants

11. Medical implants are regulated under the MDD, which classifies them in the two highest risk categories,
classes IIb and III, and the AIMDD, where all devices fall de facto into class III. As set out previously, the
risk category that a device is placed in determines how a manufacturer is able to demonstrate conformity with
the relevant Directive and the level of scrutiny required by a Notified Body.
12. Examples of class IIb implantable medical devices are bone plates and screws, gastric bands and
intraocular lenses; class III implantable medical devices are heart valves, total hip replacements and breast
implants; and active implantable medical devices are pacemakers, implantable defibrillators and cochlear
implants. Appendix A sets out in further detail the relevant definitions from the MDD and AIMDD relating to
implantable and active implantable medical devices.
13. When undertaking conformity assessment for class IIb implants a Notified Body typically carries out a
detailed assessment of the manufacturing facility to look into design, manufacturing and inspection of the
devices concerned. They also cover other general requirements such as staff training and the handling of
complaints. They will also sample technical documentation for compliance from the range of products being
manufactured. These assessments normally take place annually to ensure ongoing compliance with the
requirements of the legislation.
14. For class III implants, as well as the assessments at the facilities as outlined for the class IIb products,
there is also a requirement for the Notified Body to review the technical documentation of each product to
ensure that it is in compliance with the essential requirements. Dependent upon the product this will cover
such areas as safety, performance, biological properties, sterilisation, software and labelling.
15. For medical implants, clinical data is required to demonstrate compliance with the relevant essential
requirements. Before placing a medical implant on the market a manufacturer must have undertaken a clinical
evaluation. This process involves an analysis of clinical data that can come from a number of sources including
clinical experience of the medical device or a similar device, published clinical investigations or other studies
of similar devices in the scientific literature, or from the results of a specifically designed clinical investigation
of the device. Clinical investigations will typically be required where a medical implant has new design features
or uses new materials.
16. Clinical data for implants will typically not include an evaluation of medium- and long-term clinical
performance since it is not feasible to run pre-market clinical investigations for the expected lifetime of an
implant, nor is it usually possible or appropriate to carry out randomised clinical trials such as is done with
pharmaceuticals. A critical aspect of ensuring the safety of implants is therefore a manufacturers responsibility
to ensure that adequate post-market surveillance is in place once an implant has met the relevant requirements
for CE marking. For implants, this should include properly structured post-market clinical follow-up (PMCF)
studies designed to confirm the medium- and long-term safety and performance of the implant. This applies
equally to implants that are the subject of pre-market clinical investigations prior to CE marking and to those
that are introduced to the market on the basis of pre-existing clinical data. The results of post-market
surveillance programmes should be fed back into the risk assessment and clinical evaluation of a device by a
manufacturer and should be assessed by the Notified Body.6
17. The role of the MHRA in relation to the regulation of medical implants falls into three main areas
the oversight and designation of Notified Bodies, assessment of clinical investigations and investigation of
adverse incidents.
18. Oversight and designation of Notified Bodiesthere are currently six Notified Bodies in the UK that are
designated to undertake conformity assessment for some or all of the devices covered by the MDD and
AIMDD.7 A key role of the MHRA is to ensure that the Notified Bodies have the appropriate technical
competence to be able to cover the product scope for which they have been designated. Routine monitoring of
Notified Bodies by the MHRA involves two processesoffice audits and witnessed assessments.
19. Office audits generally focus on specific client files, reviewing the complete process from receipt of
application, assignment of assessors, reports and issue of certificates. For high-risk devices such as implants,
the audit team will include technical and clinical experts to support the assessment. In witnessed assessments
the focus is in ensuring that the assessor has the right level of competence and fully addresses all the issues
found during their assessment. Any issues in either audit process are highlighted, with the Notified Body
required to provide acceptable corrective action plans which are monitored by the MHRA.
20. Assessment of clinical investigationsas set out previously, clinical investigations are generally likely
to be required for medical implants. A clinical investigation of a non-CE marked implant must be designed to
establish that the performance claimed by the manufacturer can be adequately demonstrated, and that the device
is judged to be safe to use on patients taking into account any risks associated with the use of the device when
weighed against the expected benefits. The role of the MHRA is to assess the technical and clinical evidence
provided by the manufacturer to ensure that there are no public health or public policy reasons whereby the
6
MEDDEV guidelines 2.7/1 and 2.7/4 explain the principles of clinical evaluation and investigation in further detailsee
http://ec.europa.eu/health/medical-devices/documents/guidelines/index_en.htm
http://www.mhra.gov.uk/Howweregulate/Devices/NotifiedBodies/UKNotifiedBodiesundertheMedicalDevicesDirectives/
index.htm

proposed clinical investigation should not proceed. Examples of instances where the MHRA might object
include where there are reasonable grounds to suspect that a device does not satisfy relevant essential
requirements, or where there is inadequate pre-clinical data in order to make it reasonable for clinical testing
to commence.
21. Investigation of adverse incidentsthe MHRA investigates both mandatory serious adverse event reports
from manufacturers and adverse events reported voluntarily by healthcare professionals and members of the
public. As a result of these investigations the MHRA will take further action as appropriate, including recalling
faulty products and offering advice to the health service, primarily through Medical Device Alerts, but also
through safety pamphlets, posters, and bulletins. This illustrates the fact that many of the issues that arise in
relation to devices regulation are concerned not simply with the characteristics of the products themselves but
the interface between the product and the manner in which they are used. The MHRA therefore has an
important role in working with professionals and the public, not only to inform but also to influence their
behaviour.
22. Appendix B provides an example of how the MHRA has fulfilled this role in the past in relation to a
medical implant, and Appendix C sets out further information and statistics in relation to the MHRAs role in
medical device vigilance.8
Improving the Regulation of Medical Implants
23. This written evidence has, to this point, provided a factual account of the regulation of medical devices,
with a particular focus on how this applies to medical implants. Further important context is provided in the
number of reports and initiatives that have, are, or will be looking at issues relating to the regulation of medical
implants as well as this inquiry; these are as follows:
(a) the review of the actions of the MHRA and Department of Health (DH) in relation to Poly
Implant Prosthse (PIP) silicone breast implants, expected to be published in May 2012;
(b) the forthcoming review by Sir Bruce Keogh of the regulation of cosmetic surgery, which will
include examination of the feasibility of a register of medical implants;9
(c) the Health Select Committee report on PIP breast implants and regulation of cosmetic
interventions, published on 28 March 2012;10
(d) the proposal from the European Commission on 9 February 2012 for a joint plan of immediate
action by Member States in response to issues raised by PIP silicone breast implants;11 and
(e) the forthcoming revision of the Medical Devices Directives.12
24. This section goes on to consider how the existing regulatory framework could be strengthened,
considering first the general principles and going on to examine particular aspects in relation to medical
implants. The revision of the Medical Devices Directives is a focus for many of the potential improvements,
although there are some aspects that fall outside of the scope of this exercise.
25. The principles of the European regulatory systemrecent events involving PIP silicone breast implants
and metal-on-metal hip replacements have exposed a general lack of understanding of how the European
regulatory system for medical devices is structured and, perhaps more importantly, why it is structured in this
way. In particular, the difference to how pharmaceuticals are regulated is often used as a point of comparison.
26. One of the main differences between the regulatory systems is the differing requirements prior to a
device being placed on the market. Medical devices are unlike pharmaceuticals, in that their development is
generally based on principles of engineering, rather than of chemistry and pharmacology and, as such, greater
reliance can be placed on laboratory tests rather than clinical studies in patients. Furthermore, relatively minor
design and manufacturing improvements are frequent, and medical devices tend to evolve over time in a
manner similar to other engineering-based products; the development of the pacemaker over the past fifty
years, for example, is as a result of dozens of small design improvements made over that time.
27. Equally, it is relatively straightforward to demonstrate the short-term safety and performance of a device
which is not intended to be implanted for an extended period of time using a short-term clinical investigation
in a relatively small group of patients. The particular challenge for medical implants comes in that, unlike
pharmaceuticals and non-implantable medical devices, an implant is intended to have many years of use inside
the human body and there are limitations to what can be studied pre-market, for example in animal models.
Adverse incidents with implanted devices differ from adverse reactions to drugs in several ways: sporadic
manufacturing defects in components, operator-dependent variations in implantation, and long-term failure
related to mechanical or chemical processes in the human body. It is not feasible to adequately study the
absolute long-term safety and performance of implants in patient groups of sufficient size and diversity prior
to their being placed on the market, which is why the ongoing post-market surveillance of implants is a
8
9
10
11
12
See also http://www.mhra.gov.uk/Howweregulate/Devices/Vigilance/index.htm

For terms of reference for both reviews see
http://mediacentre.dh.gov.uk/2012/01/24/department-of-health-sets-out-scope-of-pip-implant-and-cosmetic-surgery-reviews/
http://www.parliament.uk/business/committees/committees-a-z/commons-select/health-committee/news/120322-pipreport/
http://europa.eu/rapid/pressReleasesAction.do?reference=IP/12/119&format=HTML&aged=0&language=EN&guiLanguage=en
http://ec.europa.eu/health/medical-devices/documents/revision/index_en.htm

particularly critical aspect of the regulatory system for these devices. It is the joint responsibility of
manufacturers, Notified Bodies, clinicians and regulatory authorities to ensure that this happens.
28. In addition, pre-market assessment for pharmaceuticals is undertaken by the MHRA, whereas for medical
devices this role is fulfilled by Notified Bodies. Aside from the responsibility for designation and audit of
Notified Bodies in the UK, the MHRAs only other responsibility in pre-market assessment of devices is in
assessing clinical investigations submitted by manufacturers.
29. The question is posed why this crucial role for assessing the safety of devices is delegated to Notified
Bodies and not undertaken by publicly employed experts. The rationale for employing such a system is largely
down to the size and breadth of the market for medical devicesa typical estimate is that there are in excess
of 400,000 different medical devices on the market in the EU.13 The medical devices sector is constantly
innovating, and new technologies appear at far greater rates than they do in pharmaceuticals. Individual Notified
Bodies are able to specialise in certain areas and react to market demand, adding expertise and capacity where
required in a way that would not be possible for public sector bodies. The result is a system that is efficient
and able to rapidly undertake pre-market assessment; the EU is widely recognised as being an innovationfriendly environment largely due to this regulatory structure, and the Notified Body model of third-party
involvement is increasingly being adopted in various forms by regulatory authorities outside Europe.
30. Taking the above considerations into account, the Governments departure point for considering how the
regulatory framework for implants can be improved is concerned with strengthening the current system, rather
than advocating fundamental change where there is no evidence that this would improve patient safety, and so
delay the availability of novel treatments to patients.
31. Notified BodiesNotified Bodies play a critical role in the regulatory system for ensuring the safety of
medical devices; this is heightened by the fact that the EU operates a system of mutual recognition, and so a
CE mark awarded in any Notified Body in any EU country allows free movement of that device across the EU.
32. There is general concern about the variability in performance of Notified Bodies and as such one of the
MHRAs priorities for the revision of the Medical Devices Directives has been to strengthen the criteria for
designation of Notified Bodies, and to ensure a consistent application of these criteria and monitoring of
performance of Notified Bodies across the EU.
33. The MHRA has advocated the involvement of experts from more than one Member State to be involved
in the designation and audit process, and for this process to have oversight by a central EU committee
comprised of experts from Member States. The aim of these changes would be to drive a consistently high
level of oversight of Notified Bodies, ensuring that they are designated on the basis of proven competence for
the devices that they will be assessing. This is of particular importance for higher risk devices such as medical
implants where significantly greater specialist technical and clinical input is required to adequately assess the
safety and performance of the device.
34. In advance of the revision exercise, the MHRA has been involved in a programme of peer review of
Notified Bodies, which has been a voluntary programme amongst some Member States to attempt to drive
greater consistency in the designation and audit process. The MHRA was also heavily involved in drafting best
practice guidance for designating authorities, which is increasingly used by Member States and provides a
solid base for the actions needed to improve this area.14
35. Addressing the performance of Notified Bodies has also been an area highlighted for action in the
Commissions joint plan for immediate actionwhich is a recognition that there is a need for this area to be
addressed in advance of the revision exercise, where changes are unlikely to take effect for a number of years.
In particular, this focuses on designation and audit of Notified Bodies by designating authorities, but also
highlights the requirements of Notified Bodies when they audit manufacturers, with a particular focus on
ensuring that Notified Bodies undertake unannounced inspections of manufacturers. The MHRA supports the
measures outlined in this plan and has been working with the Commission and UK Notified Bodies to address
practical implementation of the areas highlighted.
36. Clinical evaluationas outlined previously, clinical evaluation of a device is required when
demonstrating conformity with relevant essential requirements to verify the clinical safety and performance of
a device. For medical implants, this process is particularly important, as the technical and biological
characteristics of a device when implanted in the body need to be understood and documented.
37. An area that we have identified for improvement is that the Medical Devices Directives are permissive
when setting out when manufacturers need to undertake clinical investigations, or to what extent they are able
to rely on existing scientific literature and claiming equivalence with an existing device. The MHRA was key
to making changes in the last revision of the Directives such that implantable devices covered by the MDD
and devices covered by the AIMDD now require specific justification for not undertaking a clinical
investigation, but it is still the case that a large number of implants placed on the market do not have any new
clinical investigations undertaken. Furthermore, manufacturers should also be gathering clinical data on devices
13
14
http://ec.europa.eu/enterprise/newsroom/cf/_getdocument.cfm?doc_id=4854
http://www.nbog.eu/ has details on peer review and best practice guidance

in use not only to ensure the safety of those devices but also to inform the development and clinical evaluation
of future devices.
38. As Notified Bodies are responsible for assessing clinical evaluation by manufacturers as part of
conformity assessment, ensuring that appropriate clinical investigations have taken place falls to them. We
consider that many of the areas for improvement outlined in relation to the oversight and designation of
Notified Bodies in the revision of the Medical Devices Directives will result in greater scrutiny in this area
in particular ensuring that appropriate clinical expertise is in place to be able to assess clinical evaluations
but we also consider that reducing the extent to which manufacturers are able to rely on equivalence to be
critical. This can be addressed through both further strengthening the legislation and ensuring that Notified
Bodies place appropriate scrutiny on the use of equivalence.
39. Additional scrutiny on high-risk devicesa key question that is being posed as part of the exercise to
revise the Medical Devices Directives is whether additional pre-market scrutiny by public authorities is required
in some cases in addition to that undertaken by Notified Bodies. This concept was first raised in the 2008
consultation paper issued by the Commission, which proposed a role for the European Medicines Agency
(EMA) in the assessment of the highest risk devices. Whilst the idea for using the EMA has since been
disregarded, it seems likely that the Commission will include a proposal for some sort of central EU scrutiny
of new class III devices in addition to assessment by a Notified Body before they are placed on the market.
40. Whilst this idea does, at face value, appear to have some merit in providing additional assurance for the
highest risk devices, we have concerns about such a proposal. The principal concern relates to the resourcing
implications of duplicating the work of Notified Bodiesthere is a considerable amount of work undertaken
by specialist staff in Notified Bodies in conformity assessment of class III devices and it is unclear to what
extent a central EU resource will be able to scrutinise this in any meaningful way, without requiring a
substantial investment in staff. The expertise required is compounded by the breadth and complexity of class
III devices; an estimate is in excess of a thousand new class III devices are placed on the market in the EU
every year.15 An additional concern we have is that introducing this additional step could serve to muddy the
water in relation to where responsibility lies for pre-market scrutiny, and risks reducing the onus on a Notified
Body to undertake their activities properly.
41. The MHRAs view is that addressing concerns with clinical evaluation and Notified Bodiesparticularly
ensuring that those Notified Bodies designated to assess the highest risk devices are competent to do so
should drive improvements in assessing the highest risk devices, without introducing a system that will drive
up costs and delays with questionable benefits.
42. Post-market surveillancethe Medical Devices Directives require manufacturers to undertake postmarket surveillance but in rather general and imprecise terms and, as such, it is undertaken with variable rigour.
We have therefore identified this as a key area that needs to be addressed in the revision of the Directives, and
expect that there will be provisions included that more clearly set out the responsibility of manufacturers to
put in place adequate and proportionate systems to systematically collect information on the performance of
their devices in the post-production phase. We would also expect Notified Bodies to be required to assess the
appropriateness of a manufacturers post-market surveillance system as part of their assessment.
43. The MHRA has also been pressing for the concept of post-market clinical follow-up (PMCF) studies to
feature in the revised Directives. PMCF studies complement clinical evaluation prior to being placed on the
market by continuing the assessment of a device once it has been CE marked, allowing further clinical data to
be gathered once a device is in more widespread use. PMCF is one aspect of post-market surveillance, but is
particularly relevant for medical implants since a long-term assessment of the ongoing safety and performance
of a device is critical.
44. Traceabilityone key aspect of improving post-market surveillance of medical implants is in improving
their traceabilityaccurately recording an exact code that identifies the implant a patient has within an existing
dataset and then using this information to link with all relevant outcomes. The aim of this is to move postmarket surveillance of medical implants from relying largely on adverse incident reporting to a more
sophisticated proactive analysis of the ongoing performance of an implant over its lifetime.
45. The benefits of using outcomes to analyse the performance of devices have been demonstrated recently
by the central role that the National Joint Registry of England and Wales (NJR) played in identifying problems
with metal-on-metal hip replacements in 2010analysis of information from the NJR on the revision rates of
the DePuy ASR system led to a worldwide voluntary recall of the device, and has subsequently brought about
rapid changes in clinical practice in the UK.16
46. Sir Bruce Keoghs forthcoming review will examine the feasibility of a wider register for medical
implants; such a register would have the aim of gaining the benefits seen by the orthopaedic community from
the NJR across a much broader range of medical implants. In the context of this review, the MHRA is currently
examining how the current use of barcoding in the NHS17 and likely proposals in the revision of the Medical
15
16
17
Based on information provided by the French competent authority, AFSSAPS; new covers both novel devices as well as
developments of existing devices on the market
http://www.njrcentre.org.uk/njrcentre/MetalonMetalHipImplants/tabid/237/Default.aspx#DePuy_ASR_Device
http://www.dh.gov.uk/health/2012/01/it-systems-coding/

Devices Directives to mandate a system of Unique Device Identification (UDI) across the EU could be used
to facilitate better traceability of devices and linkage with outcomes. Such an approach would support
manufacturers responsibilities to undertake appropriate PMCF studies in a co-ordinated and cost-effective
manner.
47. We expect the Commission to include proposals for a system of UDI to be included in the revision,
although it seems very likely the precise details of any EU system would be specified in delegated or
implementing acts, rather than on the face of the revised legislation. The Commission recognise that different
Member States are currently addressing the issue of UDI and traceability individually, and so plan to issue a
Recommendation before the end of 2012 that will set out the principles that a UDI system should follow. At
the same time, the International Medical Device Regulators Forum (IMDRF), a collaboration between
international regulators that is replacing the Global Harmonisation Task Force (GHTF), are also addressing this
issue to support a consistent approach globally.18
48. A further initiative that the MHRA intends to explore is the feasibility of including in the revised
legislation the requirement for all implantable devices to include with them an implant card that would be
given to a patient following a procedure. Such a card would include basic details about the patient and implant,
including implant date, name of implant and batch/lot/serial number. It has become clear following media
attention on breast implants and metal-on-metal hip replacements that most patients do not know what sort of
implant they have had, and an implant card would help to support post-market surveillance, as well as providing
patients with valuable information about their implant.
49. Co-ordination and co-operationone of the key benefits from being regulated under a single EU
framework is that manufacturers of medical devices do not have to undertake a large number of costly, time
consuming assessment processes in every country in which they wish to market their device. However, there
is currently no way to systematically use the breadth of information available to individual Notified Bodies
and competent authorities across the EU to inform regulatory actions. Improving co-ordination, both within
the EU and globally is an aspect of the Commissions joint plan for immediate action and will also feature
in the revision of the Medical Devices Directives.
50. The MHRA has been encouraging the Commission to address this weakness in a number of ways. One
aspect is to require registration of all devices placed on the EU market, and the economic operators19 that do
so, on a central EU portal; this is currently the responsibility of individual Member States. A further, critical
aspect is in the development on an effective and efficient electronic communication and information support
tool to support co-ordinated post-market surveillance across the EU. Such a system would allow:
(a) centralised post-market surveillance and vigilance reporting by manufacturers, with automated
notifications to relevant Competent Authorities;
(b) access to a comprehensive EU database of post-market surveillance plans, incidents and field
safety corrective actions (FSCAs); and
(c) support for co-ordination of competent authority communications and actions.
51. We are expecting proposals from the Commission to address the areas outlined above; this will very
clearly support better co-operation and communication between Member States, but also has the added benefit
of simplifying and streamlining reporting structures for manufacturers of devices. We are also anticipating
proposals that will address the wider need to improve co-ordination and oversight of the regulatory system
covering areas such the central scrutiny process for designation and audit of Notified Bodies and ensuring
swifter determination of issues relating to the borderline between legislation for medical devices and other,
related, areas such as pharmaceuticals, cosmetics and biocides.
52. Transparencythe revision of the Medical Devices Directives provides an opportunity for a substantial
change in the availability of information about medical devices and the regulatory system. Currently, very
little information is available about a medical device throughout its lifetimeclinical evaluations, conformity
assessment, adverse incidents and post-market surveillance plans, for example, are generally not published.
Such opaqueness undoubtedly contributes to a degree of unease about the regulatory system, and a lack of
feedback to those submitting information to the MHRA through the voluntary reporting system does not help
encourage its use amongst clinicians. A key aim for the UK in the revision is therefore to drive far greater
publication of information in a format that is useful for the public, as well as regulators and manufacturers;
this is currently generally prohibited by explicit confidentiality requirements within the MDD and AIMDD that
we wish to see removed.20
ConclusionSupporting Innovation Through Regulation
53. One of the widely recognised benefits that the regulatory system in the EU brings is rapid access to the
market for new and innovative devices. Studies have suggested that new devices come to market in the EU
typically between one and two years sooner than the US, without any evidence that this comes at a higher risk
18
19
20
http://www.imdrf.org/ and http://www.ghtf.org/documents/ahwg/AHWG-UDI-N2R3.pdf

An economic operator is a manufacturer, distributor, importer or authorised representative
Article 15 of the AIMDD and Article 20 of the MDD refer

to patients and the public.21 One of the underlying objectives for the MHRA in the revision of Medical
Devices Directives is to continue to strike this appropriate balance between supporting innovation and providing
adequate safeguards to patients. Recent events involving PIP silicone breast implants and metal-on-metal hip
replacements will make this objective more challenging, as we see the immediate reaction to problems being
identified of assuming regulatory failure and calling for increased regulatory scrutinyessentially moving from
a system that balances risks against benefits to one which takes a more precautionary approach.
54. A common response to events involving PIP silicone breast implants has been to identify the US system
as an improved model that the EU should be following,22 owing largely to the fact that pre-market assessment
is undertaken by a governmental body. It is difficult to speculate whether the US Food and Drugs
Administration (FDA) would have picked up problems with PIP silicone breast implants since PIP did not
place them on the market in the US, but no regulatory system is set up to anticipate deliberate fraud. A more
relevant comparison would be to consider metal-on-metal replacementsthe DePuy ASR hip was placed on
the market in both the US and the EU, having satisfied the pre-market requirements of both regulatory
frameworks and yet, as outlined previously, problems with the implant were first identified in the UK.
55. Issues with PIP silicone breast implants and metal-on-metal hips stem from very different root causes
the first from deliberate subversion of the regulatory system and the second from unanticipated wear over a
long time-period. However, this illustrates that picking isolated examples and attributing them to regulatory
failure should not be the basis on which to advocate widespread changes to a system. Nonetheless, any
regulatory framework has room for improvement and it is important for lessons to be learned from all instances
where devices cause harm to patients. Equally, the regulatory system for medical devices does need to evolve
to reflect the increasing complexity of devices. These include new and emerging technologies that involve
novel materials and increasingly incorporate and interact with pharmaceuticals and information technologies.
56. The areas outlined in this evidencewhich generally result from considered analysis of the current
system over the course of a number of yearswill bring about significant improvement to the devices
regulatory system in the EU, whilst, at the same time, ensuring that the benefits that the EU system currently
offers, by way of proportionate, efficient and effective regulation, are not lost.
April 2012
Appendix A
DEFINITIONS RELATING TO MEDICAL IMPLANTS
A1. In order to explain fully how medical implants are regulated, it is helpful to consider the definitions
relating to medical implants.
A2. The definition of a medical device in the MDD is:
medical device means any instrument, apparatus, appliance, software, material or other article,
whether used alone or in combination, including the software intended by its manufacturer to be
used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application,
intended by the manufacturer to be used for human beings for the purpose of:
diagnosis, prevention, monitoring, treatment or alleviation of disease,
diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
investigation, replacement or modification of the anatomy or of a physiological process,
control of conception,
and which does not achieve its principal intended action in or on the human body by
pharmacological, immunological or metabolic means, but which may be assisted in its function
by such means.
A3. The definition of an implantable device within the MDD is:
Any device which is intended:
to be totally introduced into the human body or,
to replace an epithelial surface or the surface of the eye,
by surgical intervention which is intended to remain in place after the procedure.
Any device intended to be partially introduced into the human body through surgical intervention
and intended to remain in place after the procedure for at least 30 days is also considered an
implantable device.
A4. The definition of an active and active implantable device within the AIMDD is:
active medical device means any medical device relying for its functioning on a source of electrical
energy or any source of power other than that directly generated by the human body or gravity; and
21
22
http://www.eucomed.org/newsroom/8/19/EU-regulatory-system-brings-Europeans-fastest-access-to-medical-technology-withoutcompromising-safety/
and
http://www.eucomed.org/newsroom/13/19/European-patients-have-access-to-new-medicaltechnology-sooner-than-American-patients/
Eg, http://in.reuters.com/article/2012/02/03/breast-implants-regulation-idINDEE81208U20120203

active implantable medical device means any active medical device which is intended to be totally
or partially introduced, surgically or medically, into the human body or by medical intervention into
a natural orifice, and which is intended to remain after the procedure.
A5. The classification rules within the MDD relevant for implantable devices are contained within Rule 8
of the classification criteria:
All implantable devices and long-term surgically invasive devices are in Class IIb unless they are
intended:
to be placed in the teeth, in which case they are in Class IIa,
to be used in direct contact with the heart, the central circulatory system or the central nervous
system, in which case they are in Class III,
to have a biological effect or to be wholly or mainly absorbed, in which case they are in
Class III,
or to undergo chemical change in the body, except if the devices are laced in the teeth, or to
administer medicines, in which case they are in Class III.
Appendix B
CASE STUDY OF THE MHRAS ROLE IN INVESTIGATING ADVERSE INCIDENTS
B1. The MHRA was contacted by a surgeon at an Oxford hospital who was concerned about the rate of
failure of a particular Labcor Heart Valve. A team was immediately sent up to the hospital which included
clinical input, the technical expert in heart valves and experts in sterilisation and toxicology. An investigation
was launched to understand the cause of the problems; this involved interviewing relevant clinical staff,
assessing practices in theatre, liaising with the manufacturer to find out whether there had been some change
in the manufacturing process, in the sterilisation process or in the fluid used to contain valve for transport, and
contacting the FDA which had carried out a recent site visit.
B2. As a result of this extensive investigation, it became apparent that the Labcor Heart Valves require a
longer washing period prior to insertion into the patient. This was not being adequately carried out by the
theatre staff because they were used to the shorter washing periods for other heart valves. This action halted
the further unexpected failure at the hospital; at the same time the MHRA also issued a generic Medical Device
Alert bringing this issue to the attention of all cardiothoracic surgeons and cardiothoracic theatre staff.
Appendix C
THE MHRAS MEDICAL DEVICE VIGILANCE SYSTEM
Adverse Incident Investigations
C1. The MHRA operates a medical device vigilance system in the UK which encourages and provides
guidance on adverse incident reporting by:
manufacturers and their various economic operators in compliance with the Medical Devices
Directives and EU vigilance guidance;
healthcare professionals; and
members of the public, including medical device users and carers.
C2. The MHRAs system meets all EU requirements and guidance including the need to centrally record and
evaluate all information received, to inform manufacturers of all incidents received from healthcare
professionals and to warn other Member States of any corrective action or enforcement measures being taken
to address serious safety concerns.
C3. The numbers of adverse incident reports received by the MHRA has increased substantially over the
past five years:
Year
Adverse Incident reports received
2007
2008
2009
2010
2011
8,634
8,910
9,096
10,282
10,967 (a 27% increase since 2007)
C4. In addition, data from the first quarter of 2012 show a dramatic increase in reportinga 38% increase
over the first quarter of 2011.
C5. In order to handle this increasing number of incident reports effectively, two new processes were
introduced during 2011. The introduction of a triage process in April 2011 has ensured that medical device
specialists are able to focus their efforts on the most serious adverse events that require their immediate
attention and intervention, whereas more routine problems are investigated by device manufacturers in

accordance with their post-market surveillance obligations. The reports submitted by manufacturers following
their investigations are reviewed by medical device specialists and further action is taken as necessary before
transferring the adverse incident report to a trending and surveillance database.
C6. At the same time as the introduction of the triage process, a systematic trending system was established.
This trending analysis reviews adverse incident numbers by device type and manufacturer on an ongoing
periodic basis. The effective use of trending enables signals relating to incipient problems to be picked up
earlier and more consistently. Further work to develop these trending systems is planned.
C7. Outcomes of adverse investigations can include:
a Field Safety Corrective Action (FSCA) such as product recall, design change, software
upgrades, amended instructions for use, including patient management for implants;
quality assurance improvements;
device repair;
additional post-market studies;
further monitoring and trending;
local training of users or improvements in device storage; and
supplementary safety advice from MHRA including One-Liners, Device Bulletins (see below),
posters and pamphlets.
Medical Device Alerts and the Central Alerting System

C8. Medical Device Alerts are the MHRAs primary means of providing important safety advice. They can
be issued for a variety of reasons:
to provide an MHRA view or endorsement;
to inform a wider user-base;
to clarify and/or supplement information provided by a manufacturer;
to speed up user response to manufacturers Field Safety Notices; and
to provide advice on generic safety issues.
C9. In line with the increasing number of adverse incident reports received there has been a corresponding
increase in the number of Medical Device Alerts issued. The figures for the past five years are shown in the
table below:
Year
Medical Device Alerts issued
2007
2008
2009
2010
2011
100
88
85
98
113
C10. Medical Device Alerts are distributed via the Central Alerting System (CAS), a function that was
transferred from the central Department of Health to the MHRA in January 2012. CAS distributes safety
warnings to all hospital trusts and Primary Care Trusts in England. A monitoring system provides feedback on
the receipt, analysis of the need for action and completion of the required action by the addressees.
C11. An analysis of this feedback data is conducted on a regular basis to ensure that the important messages
contained within Medical Device Alerts are being received and acted upon by the recipients.
C12. In addition to the publication of Medical Device Alerts, the MHRA also publishes monthly editions of
One-Liners and Device Bulletins to address specific topics of relevance to healthcare professionals.
Liaison with Healthcare Professionals
C13. The MHRA maintains regular dialogue with a range of external stakeholders: professional bodies, trade
associations, patient user groups and external clinical experts through its expert advisory group and the
Committee on the Safety of Devices (CSD).
C14. In the past year the MHRA has made extensive use of these liaisons to cover major issues related to
PIP breast implants, metal-on-metal hip implants, and vaginal tapes for stress urinary incontinence. In addition,
consultations have occurred on a wide range of clinical issues and input has aided the assessment of clinical
investigations.

Written evidence submitted by the Association of British Healthcare Industries

About ABHI
The Association of British Healthcare Industries (ABHI) is the industry association for the medical
technology sector in the UK. ABHIs mission is to champion the benefits and use of safe and effective medical
technologies to deliver high quality patient outcomes. With over 240 members, ABHI leads the advocacy of
the industry in order to advance access to medical technology. Its membership includes many UK small and
medium sized enterprises (SMEs) and some of the leading multinational businesses in the sector.
Executive Summary
Implantable medical devices provide benefits to millions of people in the UK.
Medical devices are regulated under the Medical Device Directives. It is important that the legal
frameworks governing their introduction to the market maintain the highest standards of patient
safety.
The current system has been in place for twenty years, and like any regulatory regime dealing with
innovative products it needs regular revision. This process is currently underway.
The medical device industry supports the process of revision and has suggested a number of
amendments to the system around the following areas:
Notified Bodies.
Vigilance and post market surveillance.
Clinical Evaluation.
Mechanisms for consistent implementation.
Unique Device Identification.
Confidentiality.
Coordination and management.
The medical device industry firmly believe that if the changes outlined below, in particular those
around Notified Bodies, vigilance and consistency, are enacted and implemented Europe will have a
system which continues to support the development and introduction of innovative medical devices
that will continue to improve the lives of people across the UK whilst improving patient safety.
Introduction and Overview
1. Millions of people in the UK benefit from implantable devices. For example, each year over 150,000
people in the UK receive artificial knee and hip joints (National Joint Registry, 2011). Implants enable patients
to continue to live fulfilling working and family lives, and prevent their premature withdrawal from the labour
market. In 2009 it was estimated that 11,000 people were able to return to work following a total hip or knee
replacement, saving the welfare system 37.2 million (Bevan et al, 2011).
2. The term implant covers products ranging from active (ie powered) implants such as pacemakers to
non-active implants such as joint replacements. These products are regulated in the UK under the Medical
Device Regulations 2002 which transpose three main European Directives:
(a) Directive 90/385/EEC on active implantable medical devices (AIMDD).
(b) Directive 93/42/EEC on medical devices (MDD).
(c) Directive 98/79/EC on in vitro diagnostic medical devices (IVDD).
3. The term medical device covers a vast range of products ranging from syringes to scanners. Only a small
proportion of these products are implants. Medical devices are central to the operation of all health systems.
They enable clinicians to carry out procedures, facilitate the effective operation of the hospital infrastructure
and are often used in the home by patients themselves.
How the Current Legislation Delivers Innovation to Patients
4. Medical devices are regulated under the Medical Device Directives. The products regulated by these
directives play a crucial role in keeping the UK population healthy and productive by supporting innovation in
healthcare, while also contributing to the UK knowledge-based economy. The UK medical device sector
employs 64,000 people in the UK and is a key part of the UK life science industry that was described by the
Prime Minister as the jewel in the crown of our economy (Department of Business, Innovation and Skills,
2011). The medical technology sectors contribution to safe, efficient and life-enhancing products and services
is based on its capacity to innovate.
5. The Medical Device Directives ensure that patients receive treatment from safe products which have
undergone a thorough compliance process. At the same time, they enable the free movement of product between
EU member states.

6. The Directives were first developed in the 1990s under the framework of Europes New Approach
(today replaced by the New Legislative Framework) in response to the threat of proliferation of different
regulatory systems around Europe and the need to protect public health.
7. As with any regulatory regime that deals with a large range of products the Medical Device Directives
use a classification system. This system classifies devices by risk with the lowest risk devices being in category
I and the highest risk devices falling into category III. Implantable products are subject to the most rigorous
controls and therefore attract the most stringent compliance rules. However any consideration of the regulations
covering implants must also address the entire framework of device regulation.
8. Following extensive consultation with all stakeholders the European Union issued a Council Conclusion
in June 2011 which reaffirmed European Member States commitment to the current legal framework. This
capacity is in turn dependent on an effective and efficient EU-wide regulatory framework.
9. This framework needs to provide for patient access to safe, high quality healthcare products while allowing
for the timely introduction of innovation. Indeed good regulation should be supportive of innovation which
can deliver safer more effective products; to stifle innovation would stifle this cycle of improvement and delay
patient access to potentially lifesaving innovations.
10. We therefore believe the current regulations have been instrumental in safeguarding patients whilst
bringing them medical benefits. Like any system it is important that there is a regular review to identify
potential improvements. There have been very few instances of product failure when one takes account of the
many millions of products used annuallyit is estimated 38 million people come into contact with a medical
device every day (SEHTA, 2011).
11. The system is currently under review and the resulting Revision will be the subject of an EU Commission
Formal Proposal in mid 2012. ABHI and the medical technology industry fully support the need for changes
to the system.
The Role of the MHRA
12. We believe that the MHRA does a very effective job in implementing the Directives. It is indeed often
considered to be the pre-eminent Device authority in the EU and is well respected throughout Europe and
beyond among those concerned with efforts to achieve global harmonization in device regulation.
How can the Legislation and Regulations be Improved?
13. The system is currently under review. During wide consultation by the EU Commission a number of
potential improvements were identified. The UK medical device industry believes the system should:
be robust and comprehensive;
protect public health and enable efficient healthcare delivery;
enhance public confidence whilst avoiding unnecessary bureaucracy;
be consistent and transparent; and
effectively foster and support innovation.
14. The following points will explore this, addressing the areas where we believe reform is necessary.
Notified Bodies
15. Notified Bodies are independent third parties nominated and monitored by Member State Competent
Authorities, such as the MHRA. Therefore, they act on behalf of the member state authority that has designated
them. They carry out pre- and post-market scrutiny and certification of medical devices. The operation and
coordination of Notified Bodies is an area that industry would like to see improved as part of the Revision. As
structured today, the control and oversight by National Competent Authorities of their Notified Bodies depends
largely on voluntary and national approaches rather than on consistent, mandatory EU level rules and standards.
16. We therefore believe that Notified Bodies which are central to the New Approach system have not been
designated or controlled with sufficient rigour and that this aspect of the device regulatory system must be
improved. Steps are already being taken by the EU Commission as part of a series of short term measures
requiring Competent Authorities to review the designation of Notified Bodies. This, together with the
development of better control mechanisms, must feature in the Revision. Policy makers should focus on
oversight of notified bodies performance, rather than introduce further steps in the regulatory process. There
are currently c.80 Notified Bodies across Europe and we believe that a more robust approach to designation
should result in a significant reduction.
Vigilance and Post Market Surveillance
17. These are key features of the system and are central to its improvement in the future. The sharing of
data between Member States is crucial for patient safety; there must be a cross border communication system
that facilitates the efficient transfer of information between national Competent Authorities. The current

regulatory framework for medical devices requires vigilance and market surveillance systems to be put in place
by manufacturers and national Competent Authorities. This is intended to allow for rapid identification and
response in case of incidents which may put patient or user safety at risk or create doubt about the product
performance. At present however, there is a lack of coordinated exchange of information on reported incidents
as well as considerable variation in how different EU Member States respond to incidents. This has resulted in
both duplication of effort and inconsistencies.
18. A better defined legal framework on vigilance and greater harmonisation of Member States market
surveillance activities are therefore needed to ensure rapid and consistent EU-wide risk identification and
response. This would deliver significant benefits for overall patient safety allowing centralised reporting and
surveillance, using an EU portal for reporting.
Clinical Evaluation
19. Clinical evaluation of a device is required when demonstrating conformity with relevant essential
requirements. For medical implants, this process is particularly important, as the characteristics of a device
when implanted in the body need to be understood and documented. ABHI believes the revision of the MDDs
should see the system become more prescriptive in setting out when manufacturers need to undertake clinical
investigations, or to what extent they are able to rely on existing scientific literature claiming equivalence with
an existing device.
20. Notified Bodies are responsible for assessing clinical evaluation by manufacturers as part of conformity
assessment, ensuring that appropriate clinical investigations have taken place. ABHI therefore believes that by
improving the coordination of Notified Bodies, the scrutiny of clinical evaluation will be greatly improved.
Mechanisms for Consistent Implementation
21. Currently, the European Commission, in consultation with Member States and affected stakeholders,
issues guidelines aimed at supporting consistent implementation and interpretation of the Medical Devices
Directives. However, the process leading to development or revision of these guidelines lacks pace and legal
certainty. In addition, when the guidelines are finalised and agreed, evidence shows that there are severe
disparities in the way and extent to which they are implemented in the Member States. This has led to
significant cross-border variations in terms of quality of conformity assessment procedures, lack of process
clarity and predictability for manufacturers and national responses to vigilance.
22. These cross-border disparities must be addressed in the Revision by changing the current procedure for
development of guidelines. This needs full commitment from Member States in order to use clearly defined
and transparent drafting procedures, including timelines. This must involve all stakeholders including the
European Commission to ensure coherence with European law.
Confidentiality
23. The confidentiality requirements under the current Medical Devices Directives are seen by some
stakeholders as being too restrictive (eg in terms of access to information about products on the market, or the
functioning and decision-making of Notified Bodies).
24. The Revision of the EU legislative framework for medical devices must result in greater overall
transparency and access to information for patients, consumers, healthcare professionals and manufacturers as
well as for Notified Bodies, national Competent Authorities and the European Commission.
Unique Device Identification
25. Unique Device Identification (UDI) is a requirement for all devices to carry a machine readable identifier
(today probably a bar code but this may change as other technology becomes available). This requirement will
be included in the Revision and will be a significant step in the quest to improve patient safety. UDI will
enable a particular implant to be linked to the patient who receives it and will greatly assist in the setting up
of databases and registries. UDI will be based on internationally accepted standards and will eventually become
a global requirement for devices as it is also the subject of legislation in North America, Australia and other
regions.
Coordination and Management
26. Today the EU oversight of medical devices is decentralised and this European approach makes it possible
to manage what is a highly innovative and diverse industrial sector in terms of products, technologies and
services. The decentralised approach is best placed to provide the capacity to efficiently deal with the many
applications related to over 400,000 products on the market from over 22,000 medical technology businesses,
80% of which are SMEs.

27. The decentralised approach, which is the essence of the current system, should remain a basic principle
of the future legislative framework for medical devices in order to preserve safety, flexibility and pace.
However, the current system does suffer from disparate national approaches. It needs improved coordination
at EU level to ensure uniform application by Member States, especially in the areas of Notified Bodies and
vigilance.
How could the European Commission ensure that potential changes to the Medical Devices Directive do not
hinder the introduction of innovations in medical implants to the market?
28. As stated above the medical device directives have been instrumental in safeguarding patient safety whilst
bringing them medical benefits. The current system allows patients to access innovation at the appropriate time.
29. We firmly believe that if the changes outlined above, specifically those around Notified Bodies, vigilance
and consistency, are enacted and implemented Europe will have a system which continues to support the
development and introduction of innovative medical devices that will continue to improve the lives of people
across the UK whilst maintaining patient safety.
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April 2012
Joint written evidence submitted by Dr Thomas Joyce and Dr Pauline McCormack

Respondents
Tom Joyce is a biomedical engineer with almost 20 years of experience specialising in the design, testing,
analysis and evaluation of artificial joints including hips, knees, shoulders and fingers. He works extensively
with industry and clinicians in order to inform and improve future designs of artificial joints. He currently
supervises a number of projects around hip joint failure including: ex vivo analysis of failed resurfacing hip
prostheses; improving the metal-on-metal hip prosthesisa study of failures and wear mechanisms;
investigation of failed lower limb arthroplasties; and when technology fails patients: engaging with
stakeholders on metal-on-metal hip joint failures. He has taken part in recent investigative media programmes
highlighting problems with metal-on-metal hip failure, these include Dispatches and Newsnight in the UK,
Primetime in Ireland, Four Corners in Australia and Kontant in Denmark.
Pauline McCormack is a medical sociologist who researches social and ethical aspects of treatment, care
and research in health. She has interests in disability, notions of power, the patient voice, and how policy serves
individuals. As part of the project when technology fails patients: engaging with stakeholders on metal-onmetal hip joint failures, she is collecting data from patients and their families about their experiences with a
failed hip implant.
Scope
Our submission to the Committee focuses on an area of recent controversy, that of failed metal hip implants,
which intersects with our areas of expertise. We will concentrate on:
1. Engineering analysis of failed metal-on-metal hips. We have examined components from almost
400 failed hips and published much of our data. We are the only independent centre in the UK,
and probably the world, undertaking such extensive research. We were the only research group
in the world to publish critical data on the DePuy ASR metal-on-metal hip prior to its worldwide
recall in August 2010.

2. Qualitative data from patients about their lived experiences. We believe we are the only people
in the world undertaking specific, sociological research into current patient experiences with
failed metal-on-metal hip implants, gathering data on their daily lives and the impact on their
work, families and social activities. We are in the midst of data collection and, while the
findings presented here are very preliminary and are unpublished, we are prepared to make
them available to the committee as we feel strongly that the patient voice should be audible in
these deliberations.
Responses to the Consultation Questions
1. Are current legislation and regulations on safety and efficacy of medical implants fit for purpose?
No. In the case of hip joint replacements we believe that this has been shown in various scientific publications
(Langton, Jameson et al, 2008; Joyce, Langton et al, 2009; Langton, Sprowson et al, 2009; Langton, Jameson
et al, 2010). To give the Committee a summary idea of the problems, we cite the example of the DePuy ASR
hip which was implanted into almost 100,000 patients worldwide (around 10,000 UK) and which is responsible
for causing widespread health problems in patients. This has been described as perhaps the biggest disaster in
the history of orthopaedics. As international experts in implant design and analysis we have no idea whether
this device was tested before it was implanted in patients, as there is no regulatory requirement for such tests.
If it were tested in house, we have no idea what the results were as there is no legislative or regulatory
requirement for companies to publish data.
For a detailed discussion of the general problems, particularly those of substantial equivalence, we would
refer the committee to the work of colleagues who are experts in regulatory affairs (Heneghan, Thompson et
al, 2011; Matthew, Carl et al, 2011; Heneghan, Langton et al, 2012).
In engineering terms we believe that the international standard ISO14242, Implants for surgeryWear of
total hip-joint prostheses is not detailed enough and should be amended to include specific guidance on the
testing of acetabular cups at various angles of inclination and anteversion. In addition, it should require the
smallest and largest sizes of artificial hips to be tested. Had such pre-clinical tests been undertaken on the ASR
then the current disaster might have been averted.
Data from patients with failed metal-on-metal hip implants shows they are perplexed, confused and often
angry as to why, in their opinion, the regulatory system has not protected them. They query how effective the
system is, which allowed hip joints which are failing so disastrously, onto the market in the first place.
...the medical regulatory bodies, theyve really got to protect us better and theyre not being bold
enough in doing that, theyre passing the buck. (Focus Group patient)
2. How effectively does the MHRA implement the Directive in the UK?
This question does not draw attention to the fact that, if the Directive is not fit for purpose, then the
effectiveness of its implementation is largely academic.
In our patient focus groups people consistently interrogated the responsibilities of the MHRA and concluded
the MHRA do not have a clear remit and lacked sufficient authority to take responsibility over, and act
decisively on implant failure. The patients saw the gap in responsibilities as ethically and morally wrong.
[We] were really annoyed that the regulatory body, we felt that they shirked their responsibility
and, what is the regulatory body? Has it not got enough teeth? (Focus Group patient)
Worryingly, they interpreted the lack of action as evidence that the regulator could not be impartial or
independent.
3. How could the legislation and regulations be improved?
We outline a number of areas where we believe legislation and regulation should be improved, points (i)
and (ii) should be treated as urgent:
(i) Testing
The reality is, you cannot test the wear patterns of human joint replacement in any animal
species.23
I cannot believe in this advanced technological age that no-one could design a machine that would
replicate the movement of variously fitted hip joints. (Patient panel participant)
23
Professor Sir Kent Woods, Chief Executive, MHRA http://www.bbc.co.uk/news/health-17200330

Observations about testing human joints in other species are spurious and the apparent lack of understanding
by the regulator on this point is disturbing. Fortunately, machines do exist to wear-test human joint
replacements. They originated in the UK in the 1960s (Duff-Barclay and Spillman 1966) and are validated to
international standards (ISO 14242:2000). They have been further developed since then and are now
commercially available. It is our view that stringent, mechanical, pre-implantation, testing should be mandatory
for all joint replacement implants and that test data should be publicly available. Ideally such testing should
be undertaken independently by not-for-profit organisations, as designers and engineers working for companies
could be subject to commercial pressure which can lead to publication of favourable results (Schott, Pachl et
al, 2010). At the very least, if testing is allowed by commercial companies for their own products, test data
should be open to scrutiny by independent experts and the public.
We believe that the international standard ISO14242, Implants for surgeryWear of total hip-joint
prostheses is not detailed enough and should be amended to include guidance on the testing of acetabular
cups at various angles of inclination and anteversion. In addition, the smallest and largest sizes of artificial
hips should be tested.
(ii) Explant retrieval and analysis
Examination of explanted joints that have failed or caused problems in the body is one of the most valuable
sources of data about how and why implants failthey can be thought of as the black box. Revision
operations, which remove such problem implants have to be reported to the National Joint Registry (NJR) but
conservation of the failed joint itself is not required and many are simply thrown away. We have some evidence
of surgeons and hospitals disposing of joints even when patients have requested that the joint be kept to be
sent for analysis.
We call for the conservation and analysis of explanted joints to be made mandatory as part of the NJR
reporting procedure. This analysis should be undertaken by independent, not-for-profit experts. Such a move
might be facilitated by the establishment of a national explant retrieval centre and the committee should
consider putting in place consultations for how such a centre could be managed and funded. One option might
be a universal tariff on all new joints, as currently funds the NJR. Another option would be that a charge is made
to the manufacturer for each joint examinedin this way manufacturers would be additionally encouraged to
design and produce joints with the greatest longevity.
(iii) Symptom reporting
We have repeated reports from patients that their concerns over symptoms from their hip implants were
dismissed and/or ignored by medical professionals. We believe that the Yellow Card System, whereby a user
of medication can report side effects directly to the MHRA, could be usefully expanded to include users of
medical devices.
(iv) Data transparency and results publication
We join the ever-growing body of professionals who are calling for greater transparency of the results of
experiments, particularly in medical trials and testing where the results can have profound implications for
patients (Groves 2010; Alsheikh-Ali, Qureshi et al, 2011; Ross, Lehman et al, 2012; Wellcome Trust 2012).
Research and innovation moves more quickly in a positive direction when data and findings are shared between
investigators, meaning they can build on colleagues work. The practice of pharmaceutical companies
publishing mainly favourable data means that investigators do not get to learn from the mistakes of others and
may waste valuable time repeating failed experiments (Schott, Pachl et al, 2010; Lundh, Krogsbll et al, 2011).
The NJR is something that this country should be proud of. It is the largest such registry in the world, but
we should consider whether the raw data contained in it could be made more readily available. We also suggest
that the NJR should be expanded to cover all artificial joints.
The NJR could also provide a publicly available, adverse event reporting website along the lines of the
MAUDE (Manufacturer and User facility Device Experience) database offered by the FDA in the USA, so that
all interested parties can view this important data.24
We believe surgeons should be required to disclose payments received from orthopaedic companies and that
such data should be made publicly available as is the practice in the USA. This would free medical
professionals from accusations that their choice of treatment or device for their patient is not based on the
patients welfare. Such an observation was made in our focus groups and in a patient panel:
If you cant trust the surgeon who is the expert, to give you the best advice and a device that is
suitable for you, not one that has been sold to them, who can you trust? Are patients just pound
signs at the end of the day? (Patient panel participant)
24
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm

4. How could the European Commission ensure that potential changes to the Medical Devices Directive do
not hinder the introduction of innovations in medical implants to the market?
It is a misconception that more regulation hinders innovation. As President Obama said in his 2012 State of
the Nation address rules to prevent ... faulty medical devices dont destroy the free market. They make the
free market work better. As noted above, regulation can aid collaboration and mutual education through
transparency and openness, which only helps innovation. In addition, regulating medical devices to ensure that
better products reach the market means that devices sold will be more efficient and successful, which will
result in better uptake from surgeons and greater trust from patients. Evidence shows that devices in the USA
which follow a longer, stricter regulation route are more successful and have fewer recalls (Heneghan,
Thompson et al, 2011).
This said, we caution against a constant focus on innovation rather than on patient safety and precautionary
measures. Innovation should result in improvement or enhancementnot for their own sake but in order to
pass on improved treatments to the patient. The current situation around medical devices is such that not only
does the system not guarantee improvements for patients, it hampers them.
The last word in our submission goes to the patients, who are astute in summarising what action they would
like to see taken:
We are just saying that the MHRA need to learn and listen to the experts, take action without fear
of being sued and the government need to step in and sort out the seeming corrupt practices and
hidden and unacknowledged evidence. (Focus Group patient)
We here on the shop floor are suffering, so everybody should be responsible for bringing this out
into the open and making sure it doesnt happen again. (Focus Group patient)
References
Alsheikh-Ali, A A, W Qureshi, et al (2011). Public Availability of Published Research Data in High-Impact
Journals. PLoS ONE 6(9): e24357.
Duff-Barclay, I and D T Spillman (1966). Paper 10: Total Human Hip Joint Prostheses: A Laboratory Study
of Friction and Wear. Proceedings of the Institution of Mechanical Engineers, Conference Proceedings
181(10): 90103.
Groves, T (2010). The wider concept of data sharing: view from the BMJ. Biostatistics 11(3): 391392.
Heneghan, C, D Langton, et al (2012). Ongoing problems with metal-on-metal hip implants. BMJ 344.
Heneghan, C, M Thompson, et al (2011). Medical-device recalls in the UK and the device-regulation process:
retrospective review of safety notices and alerts. BMJ Open 1(1).
Joyce, T J, D J Langton, et al (2009). Tribological analysis of failed resurfacing hip prostheses and comparison
with clinical data. Proceedings of the Institution of Mechanical Engineers, Part J: Journal of Engineering
Tribology 223(3): 317323.
Langton, D J, S S Jameson, et al (2010). Early failure of metal-on-metal bearings in hip resurfacing and largediameter total hip replacement: a consequence of excess wear. J Bone Joint Surg Br 92-B(1): 3846.
Langton, D J, S S Jameson, et al (2008). The effect of component size and orientation on the concentrations
of metal ions after resurfacing arthroplasty of the hip. J Bone Joint Surg Br 90-B(9): 11431151.
Langton, D J, A P Sprowson, et al (2009). Blood metal ion concentrations after hip resurfacing arthroplasty:
A comparative study of Articular Surface Replacement and Birmingham Hip Resurfacing arthroplasties. J
Bone Joint Surg Br 91-B(10): 12871295.
Lundh, A, L T Krogsbll, et al (2011). Access to data in industry-sponsored trials. The Lancet 378(9808):
19951996.
Matthew, T, H Carl, et al (2011). Medical device recalls and transparency in the UK. BMJ 342.
Ross, J S, R Lehman, et al (2012). The Importance of Clinical Trial Data Sharing. Circulation: Cardiovascular
Quality and Outcomes 5(2): 238240.
Schott, G, H Pachl, et al (2010). The Financing of Drug Trials by Pharmaceutical Companies and Its
Consequences Part 2: A Qualitative, Systematic Review of the Literature on Possible Influences on Authorship,
Access to Trial Data, and Trial Registration and Publication. Deutsches Arzteblatt International 107(17):
295-U213.
Wellcome Trust (2012). Data sharing. Retrieved 25 April 2012, from http://www.wellcome.ac.uk/About-us/
Policy/Spotlight-issues/Data-sharing/.
April 2012

Written evidence submitted by Professor Stephen Westaby

The breast implant and metal hip joint issues have diverted attention away from other serious problems. I
would like to reiterate that more patients die from limits in access to medical technology than from faulty
equipment. In some cases restrictions based on cost containment contravene NICE and GMC guidelines and
may infringe human rights (please see enclosures). If the UK is to meet the aspirations of world class
healthcare outcomes proposed in the recent White Paper, Equity and Excellence: Liberating the NHS, then
systems of care must keep pace with advances in technology. The single most important issue is timely access
to new life saving drugs and equipment. This is an area where the NHS in some cases remains well behind the
rest of Europe and North America. We need access to modern imaging for early diagnosis, to telemedicine, to
technology based cancer and cardiac care and many other advances which remain restricted for cost
containment reasons. It is unreasonable to publish outcomes for hospitals and medical professionals based on
simple Hospital Episode Statistics without providing modern equipment to save lives. There are weekly NHS
scandals and considerable litigation costs due to current limitations. More complicated and protracted device
regulation and licensing will not solve these problems.
13 June 2012
Written evidence submitted by Jacqueline Minor, European Commission

I would like to thank the Members of the House of Commons Science & Technology Committee for having
given me the opportunity to provide the European Commissions views with regard to medical device regulation
in the EU.
As I mentioned at the session on 13 June 2012, enhancing transparency of the regulatory system is one key
element of the revision of the existing medical devices directives. The European databank on medical devices
(Eudamed) should be further developed and become the central piece of an EU portal storing information
regarding medical on the EU market and giving access to such information.
In future, Eudamed should be composed of the following electronic systems:
an electronic system on Unique Device Identification (to allow traceability of medical devices),
an electronic system on registration of devices and economic,
an electronic system on information on certificates issued by notified bodies,
an electronic system on clinical investigations in relation to medical devices,
an electronic system on medical device incidents (vigilance), and
an electronic system for sharing information on market surveillance activities of the Member
States.
In the impact assessment carried out to prepare the draft legislative proposals, we estimated the approximate
costs for setting up the future Eudamed databank with its various integrated electronic systems at EUR 2mio/
year for a period of four years, followed by annual maintenance and development costs of EUR 1.8mio/year
(including software for statistical analysis of reported incidents for signal detection).
Unfortunately, I cannot share with the Committee the draft legislative proposals which the Commission plans
to adopt by the end of September 2012.
But I have compiled some draft provisions which relate to the subject-matter of my oral witness statement
and which aim at enhancing the transparency of the system, ensuring traceability of medical devices, achieving
a high level of commonality in the designation of notified bodies and making the vigilance system more
effective.
Those provisions are part of the draft proposals which are currently subject to the consultation of the various
Commission departments and remain internal documents. I would therefore ask you to keep this enclosed
document strictly confidential.25
As part of Commissioner John Dallis plan for immediate action to restore trust in the regulatory system
after the PIP incident, the European Commission is currently working, in cooperation with the Member States,
on measures to strengthen the implementation of the existing medical devices directives. One measure aims at
bridging the gaps in the practices of the Member States in relation to the designation and monitoring of notified
bodies. The other measure aims at setting uniform criteria to be followed by notified bodies during the audits
they perform under the medical devices directives. I enclose the two measures in their draft versions which are
currently subject to stakeholder consultation and are therefore not confidential.
25
Not printed

Enclosure26
1. Selected draft provisions from the proposal for a Regulation on medical devices.
2. Draft Commission Regulation on the designation and the supervision of notified bodies under Directives 90/
385/EEC on active implantable medical devices and 93/42/EEC on medical devices.
3. Draft Commission Recommendation on the audits performed by notified bodies in the field of medical
devices.
Written evidence submitted by BSI Healthcare

Introduction
On 26 March 2012, the House of Commons Select Committee on Science and Technology announced its
plans to examine the regulation of medical implants and invited written submissions from interested parties.
This document contains BSI Healthcares submission to the Select Committee.
In the UK BSI operates a full scope Notified Body (NB number 0086) that certifies products under the
Medical Devices Directive, Active Implantable Medical Devices Directive and the In Vitro Diagnostic Devices
Directive. It is designated to do so by the MHRA. The German competent authority designates BSI Germanys
Notified Body (NB number 00535) to certify medical devices and in vitro diagnostic devices. The notified
bodies operate separately from BSIs National Standards Body.
Between 8 May and 2 July 2008, the European Commission consulted stakeholders on the revision of the
legal framework for medical devices. Many of the issues the Commission raised are pertinent to the Select
Committees enquiry.27,28
1. Are current legislation and regulations on safety and efficacy of medical implants fit for purpose?
Since 1993 (mandatory from 1998) the Medical Device Directive 93/42/EC has provided the framework for
medical devices to achieve EU market access, during this period (as accepted by the recent EC report prior to
revision 2007/47/EC) this framework has largely been recognized as appropriate for the regulation of medical
devices within Europe.
The framework has demonstrated flexibility and adequacy in providing appropriate regulatory paths for
10,000s of types of medical devices with only limited need for adjustment or reclassification to address specific
concerns. The major stakeholders have in the main been satisfied with its functioning.
Over time opportunities for improvement have been identified and the latest review 2007/47/EC, along with
the new regular meetings of NBOG and the Borderline and Classification Work Group, has addressed
outstanding issues as they have been identified. In fact the preamble to 2007/47/EC indicates there is a lot of
support from all stakeholders for the existing framework. The EU Medical Devices Directive based on the
New Approach has achieved significant consensus and consistency in understanding and implementation. The
current status of agreement and common understanding is the outcome of significant stakeholder investment
and many man years of effort and work, the value and cost of this understanding and consensus should be
weighed carefully when considering the benefits of any substantial change to the current framework.
The current framework provides key benefits that include:
(a) A comparable record of device safety with other mature regulation frameworks (eg, US FDA),
which is demonstrated by the relatively low occurrence of recalls and clinical issues.
(b) Timely product evaluations compared to other approval based regulatory schemes, such as
drugs and plant protection products, and to devices under other regulatory frameworks outside
the EU.
(c) Available regulatory review resources and competences that have already been established and
demonstrated to support safe, timely product evaluations.
(d) A system that is adaptable and does not stifle innovation.
Timely efficient review of medical devices is important to Europe from several perspectives:
(i) Patients benefit from access to the most advanced, safe and effective state of the art
technology;
(ii) Healthcare systems and payers benefit from a competitive supply environment that drives device
manufacturers to continuously improve devices and that ensures an available selection of
competitive devices to drive competitive pricing; and
26
27
28
Not printed
BSI submission to the European Commissions Consultation into the revision of the Directives http://ec.europa.eu/enterprise/
newsroom/cf/_getdocument.cfm?doc_id=4901, and is attached to this submission for convenience.
Other stakeholders responses to the Commission http://ec.europa.eu/health/medicaldevices/
documents/revision/index_en.htm.

(iii) A strong, vibrant, innovative medical device sector is beneficial for European economic stability
and development.
In general BSI considers the current regulatory framework for medical devices in the EU as satisfactory
but has concerns over the consistent implementation and that addressing these aspects would deliver further
improvement in the quality, integrity and consistency of evaluations.
2. How effectively does the MHRA implement the Directive in the UK?
The MHRA is one of the leading and most respected Competent Authorities in Europe. It is responsible for
the designation of Notified Bodies under the Medical Directives and has designated BSI under the MDD,
AIMD and the IVDD. The MHRA regularly audits BSI in respect of its procedures and processes in
implementing conformity assessments under this designation. BSI considers the audits to be thorough which
are conducted by technical and clinical experts.
3. How could the legislation and regulations be improved?
As mentioned before, BSI believes the basic regulatory framework is robust and protects patients
appropriately; it is likely the forthcoming EU Commission revision will propose improvements that will help
with consistency and implementation of the rules, in a number of areas which BSI would welcome.
Notified Bodies
Notified Bodies like BSI are independent third party organizations designated by Member State authorities,
such as the MHRA. Their control and oversight is by National Authorities who often have different approaches
to the role, and there are inconsistencies between National Authorities in terms of the rigour with which Notified
Bodies have been designated and controlled. Any new regulation should focus on consistent, mandatory EU
level rules and standards, and the development of better control mechanisms. Policy makers should focus on
oversight of Notified Bodies performance, rather than introduce further steps in the regulatory process.
Vigilance and post market surveillance
Member states need a robust and transparent system of sharing data efficiently between national Competent
Authorities. BSI feels that the system can be improved, starting with improved reporting of incidents within the
healthcare authorities. BSI provided the following statement in 2008 at the time of the European Commissions
Consultation into the revision of the Medical Directives:
One or more proposals to improve the vigilance system could be foreseen to be appropriate. In each case
can you give an estimate of the socio-economic impact of the particular proposal?
Proposal 1: Establish an obligation for the medical institutions and healthcare professionals to report
incidents and to invite patients to do the same, to introduce timelines for reporting and corrective actions, to
give certain publicity to the corrective actions of the manufacturer:
An obligation on users of devices to report incidents seems to have merit, such a systems must
ensure that all reports are made available to the appropriate medical device manufacturers so that
manufacturers can fulfill their vigilance reporting and incident investigation obligations.
Proposal 2: Create an obligation for the Notified Body to periodically review the manufacturers vigilance
system:
This is already required by the Directive and should be applied by the Notified Bodies. Today the
vigilance system should be a routine part of each Notified Body audit of medical device
manufacturers. If this is not the case enforcement is the responsibility of the DA.
4. How could the European Commission ensure that potential changes to the Medical Devices Directive do
not hinder the introduction of innovations in medical implants to the market?
Overall, BSI considers that the EU medical device regulatory system as it stands provides an adequate
framework to deliver safe devices to the market that are fit for purpose but it is recognized that all stakeholders
need to make full use of the powers available to them under the Directives and for the designation and
monitoring of the implementation of those measure to be consistently applied across the EU.
After 20 years, however, notwithstanding the various updates to the regulations there is always scope to
improve some aspects. The improvements in medical implants in that time have improved the quality of life
of millions of patients and this has been possible because the sectors regulatory system has enabled the speedy
introduction of safe innovative product. There have been criticisms that the system is not stringent enough and
suggestions that devices need a regulatory regime like that applied to pharmaceuticals, with pre market approval
by a centralized authority and randomized controlled trials.
However, medical devices are different to pharmaceuticals. The extremely diverse range of technologies is
subject to more frequent design changes and a rapidly evolving state of the art. Unlike pharmaceutical products,

implantable medical devices have significant reliance upon surgeon skill and accessory products to achieve
successful outcomes. This makes the pharmaceutical approach to regulation unsuitable for medical devices.
The Medical Devices Directives and many of the associated European regulatory guidance documents have
been updated in the last few years; we are not yet seeing the full benefits of these changes. European policy
makers should implement changes that reinforce standards and consistency within the current framework to
continue to support a thriving industry that develops and introduces innovative medical devices that improve
millions of peoples lives.
April 2012
Supplemenatry written evidence submitted by BSI Healthcare

During the Select Committee Session on 13 June 2012 and during the questioning regarding the potential
for manufacturers to shop around and find a Notified Body (NB) which would accept lesser standards, I was
asked to provide further information following the meeting. These aspects were covered within Q55 and Q56
of the meeting transcript.
BSI issues more than 300 new certificates to medical device manufacturers under the Medical Devices
Directive each year. Those certificates are comprised firstly of Conformity Assessment certificates covering the
Quality System and additionally, in the case of the higher risk devices a product related Design or Type
Examination certificate.
In respect of the QMS certificates, BSI does not consider there to be a great deal of forum shopping
although there is an amount of turnover where manufacturers, for one reason or another, would chose to switch
Notified Bodies. BSI does not view this to be a widespread or high risk practice, although in a number of
cases, there may be some correlation between those manufacturers moving to another Notified Body and the
number of issues identified over previous audits. Due to the many factors involved it is difficult to evaluate
the exact reason for manufacturer deciding to change to a different NB. When this does occur there is an
expectation, although not currently mandated, that the new NB would communicate with the original NB to
determine whether any specific problems existed. This process of exchange of information and communication
is generally adopted by most of the recognised NBs but it is in no way universally implemented.
The main concern that BSI sees with forum shopping is in respect of the higher risk devices for which a
product related Design or Type Examination certificate is required from a Notified Body prior to the
manufacturer being able to declare compliance with the directive and place product on the market. In these
situations there is the potential for a manufacturer, faced with demands from the Notified Body to submit more
comprehensive information, particularly clinical data to support device safety, to withdraw an application and
seek another NB. BSI has been aware of situations where a manufacturer has withdrawn an application and
has been successful just a few months later, clearly without any further clinical data, to gain certification
through another NB.
A review of our records has shown that BSI is aware of seven clear cases over the last five years where a
manufacturer has successfully had a device certified through another NB following an application whereby it
had been deemed by BSI that the available clinical data was not adequate in meeting the requirements of
Annex X of the MDD.
Of the seven cases identified, there were four US manufacturers, one Canadian, one European and one from
Japan. The devices concerned have included orthopaedic joints, spinal implants, bone graft substitutes, coronary
implants, vascular stents and an intra-ocular lens.
It should be emphasised that the instances of this nature are relatively rare but the consequences of each
individual case could be very significant in respect of patient safety.
June 2012
Supplementary written evidence submitted by the Association of British Healthcare Industries

I am writing to you following the oral evidence session on 13 June 2012. First of all I would like to thank
the Committee for giving ABHI the opportunity to discuss the important issue of medical implant regulation
with the Committee.
I will address the points raised during the session. On the issue of Notified Bodies (NB), I would like to
express industrys support for the principles of the current system. Unfortunately, there are areas where the NB
system has shown signs of weakness. Industry believes the following measures will help improve the system:
Precise and mandatory requirements for the designation of Notified Bodies;
EU-wide mandatory accreditation standards for Notified Bodies, which include standards for
competence, training, staffing, transparency and expertise of Notified Bodies;

Precise, binding, transparent measures for Competent Authorities to control and monitor the activities
and performance of Notified Bodies;
Audits of Notified Bodies by joint teams composed of different national Competent Authorities and
the European Commission;
EU-level oversight of the way Member States designate and monitor their Notified Bodies.
In regards to manufacturers shopping round for less rigorous NBs, ABHI does not believe this to be
common practice. Medical device manufacturers work closely with their NB throughout the process of
developing a compliance dossier for a medical device. It is not the case that they simply choose a NB at the
end of the process and submit their evidence. Moreover, the process of changing from one NB to another is
expensive and time consuming. It involves the need to carry out new conformity assessments, other checks on
manufacturing facilities and costly re-labelling programmes.
Also discussed during the session was the issue of evidence sharing and transparency of information. At
present, the current arrangements for the control of data are seen by many as too restrictive. Industry believes
that information regarding devices on the market, vigilance, market surveillance, clinical investigation and CE
certificates should be widely available to patients, consumers, healthcare professionals and manufacturers, NBs,
national Competent Authorities and the European Commission. Obviously the level of information available
could vary according to the intended recipient as was suggested in the evidence submitted by Mrs. Minor from
the EU Commission.
At present the oversight of medical devices is highly decentralised and largely controlled by Member States.
This approach makes it possible to manage the 400,000 products on the market and the thousands of new
products introduced each year. The current system does, however suffer from disparate national approaches.
There is therefore a need for some added coordination at EU level to iron out some of the discrepancies
between EU Member States. This could be facilitated by a central body would have a key role in overseeing
the auditing of NBs and coordination of vigilance reporting systems.
However industry does not believe that establishing a single organisation that carries out CE marking
centrally is a workable system for medical devices. The establishment of such a body would be very expensive
and fraught with difficulties. We do not believe that a more centralised system would make a real difference
to patient safety. In our opinion it would be an expensive way to slow down patient access to innovative
treatment and would indeed be a heavy burden on the public purse.
A final area of improvement is around the coordinated and rapid sharing of information in relation to products
on the market. Industry supports a better defined legal framework on vigilance and greater harmonisation of
Member States market surveillance activities are needed to ensure rapid and consistent EU-wide risk
identification and response. This would require a centralised reporting system based on an EU portal for
reporting of key data and situation assessment by Member States and the European Commission.
I hope you found our evidence useful. Patient safety is of paramount importance to our industry. We work
alongside the NHS in a relationship of mutual dependency. If this relationship is to continue to be a success
and deliver innovative new treatments to patients, then we will need a regulatory regime that industry, clinicians
and patients have faith in. Like any system dealing with innovative technologies, the regulatory regime for
medical devices will have to constantly evolve and keep pace with the technologies it regulates. The medical
device industry believes the ideas listed above, and those from our original submission will help deliver a
regulatory system that gets innovation to patients whilst maintaining the highest standards of patient safety.
June 2012
Printed in the United Kingdom by The Stationery Office Limited

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Science and Technology

Science and Technology Committee

Regulation of medical implants in the EU and UK

Regulation of medical implants

Conclusions and recommendations

List of printed written evidence

List of additional written evidence

List of Reports from the Committee during the current Parliament

Regulation of medical implants in the EU and UK

Regulation of medical implants in the EU and UK

Regulation of medical implants in the EU and UK

Regulation of medical implants in the EU and UK

What we regulate, MHRA, www.mhra.gov.uk

Medical devices: Regulatory Framework, European Commission, ec.europa.eu

Regulation of medical implants in the EU and UK

Regulation of medical implants in the EU and UK

What we regulate, MHRA, http://www.mhra.gov.uk/

Council Directive 93/42/EEC; Ev 7, para A3

This covers all medical devices

For use outside the body

The Notified Body: Bulletin No. 6, MHRA, January 2006

Notified Bodies, Department of Business, Innovation and Skills, www.bis.gov.uk

Regulation of medical implants in the EU and UK

The Notified Body: Bulletin No. 6, MHRA, January 2006

UK Notified Bodies under the Medical Devices Directives, MHRA, www.mhra.gov.uk

The Notified Body: Bulletin No. 6, MHRA, January 2006

The Notified Body: Bulletin No. 6, MHRA, January 2006

Regulation of medical implants in the EU and UK

the competent authorities of all countries in which the device is used;

the competent authority in their own country; and

Notified bodies are explained further in paragraph 10

About us, MHRA, www.mhra.gov.uk

Regulation of medical implants in the EU and UK

High profile medical device recalls

Regulation of medical implants in the EU and UK

Metal-on-metal hip implants

Hip resurfacing, American Academy of Orthopaedic Surgeons, orthoinfo.aaos.org

Hip replacement: introduction, NHS Choices, www.nhs.uk

Inflammatory arthritis of the hip, American Academy of Orthopaedic Surgeons, orthoinfo.aaos.org

Metal-on-metal hip implants, US Food and Drug Administration, www.fda.gov

Hip resurfacing, American Academy of Orthopaedic Surgeons, orthoinfo.aaos.org

Hip implants, American Academy of Orthopaedic Surgeons, orthoinfo.aaos.org

ASR hip replacement guide, DePuy, www.depuy.com

Metal-on-metal hip implants, MHRA, www.mhra.gov.uk

Articular surface replacement

Regulation of medical implants in the EU and UK

What we regulate, MHRA, www.mhra.gov.uk

Regulation of medical implants in the EU and UK

provided by manufacturers, notified bodies then assess a devices short-term compliance

published clinical investigations or other studies of similar devices in the scientific

clinical experience of the medical device or a similar device; or

Ev 33, paras 1314

Regulation of medical implants in the EU and UK

Regulation of medical implants in the EU and UK

Regulation of medical implants in the EU and UK

Before applying, National Research Ethics Service, www.nres.nhs.uk

Regulation of medical implants in the EU and UK