Post-market

surveillance
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Background to changes
The Medical Devices Regulation (MDR) (Regulation (EU) 2017/745) and In Vitro Medical Device
Regulation (IVDR) (Regulation (EU) 2017/746) are significant changes to European legislation for
medical devices. Understanding the requirements is essential to your ability to provide the European
Union market with safe medical devices that perform as intended and comply with the Regulations.
One of the areas that has been changed substantially in the new Regulations relates to the ongoing
oversight by the manufacturer of devices once they are on the market. This is consistent with the
gathering of information from the post-production phase referred to in  EN ISO 14971:2012,  the
international and European standard for risk management.  EN ISO 13485:2016, the standard for
quality management systems (QMS) for medical devices, also references using data from
post-production activities in feedback processes as well as requiring that post-market surveillance
(PMS) is used to maintain the safety and performance of medical devices.

PMS is undertaken as a responsibility of the manufacturer – it is different from ‘market surveillance’,

which is used to describe activities to monitor compliance with the Regulations undertaken by, and
coordinated between, national competent authorities.

The current Active Implantable Medical Devices Directive (AIMDD) (90/385/EEC), Medical Devices
Directives (MDD) (93/42/EEC) and In Vitro Diagnostic Medical Devices Directive (IVDD) (98/79/EC) are
repealed on the date of application of the MDR and IVDR, unless any provisions are specifically
identified otherwise. Article 120 of the MDR and Article 110 of the IVDR, Transitional provisions, allow
that a device with a valid certificate that was issued in accordance with the MDD, AIMD or IVDDD can
be placed on the market or put into service for a defined period after the date of application of the
Regulations, provided the device continues to comply with those Directives and there are no significant
changes in the design and intended purpose. However, the requirements of the Regulations relating to
(1) post-market surveillance, (2) market surveillance, (3) vigilance, (4) registration of economic

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operators1 and (5) registration of devices1, apply in place of the corresponding requirements in the Directives
from the date of application.

For the MDR, the transition period is three years. The transition period of the MDR ends on the date of
application, 26th May 2020.

For the IVDR, the transition period is five years and so the date of application for the IVDR, and the end
of its transition period, is 26th May 2022.

Therefore, the vigilance and PMS requirements in the MDR and IVDR apply to:

1 all devices from the date that they are CE marked under the MDR or IVDR, whether applied during the
transition period or after the entry into force; and

2 any devices CE marked and legally marketed under the Medical Devices Directive or In Vitro Diagnostic
Medical Devices Directive after the date of application of the Regulations.

In many aspects, the requirements of the IVDR parallel the MDR; this guidance is intended to be as generic
as possible and apply to both Regulations unless specifically indicated as applicable to medical devices or
in vitro diagnostic (IVD) devices specifically.

An overview of the requirements for vigilance and PMS is summarized in Table 1.

This will not apply until Eudamed becomes available which may not be on the date of application of the Regulation.
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 Element of the
Description MDR IVDR
Regulation

Post-market
surveillance
system Proactive and systematic

MDR Article 83: Allows cooperation on vigilance and market surveillance

Post-market Comprehensive
surveillance system to Connects with corrective action or preventive action
system of the gather processes
manufacturer experience
from the use Allows update of technical documentation, including the
MDR Article 15: of devices risk-benefit determination and clinical evaluation/per-
Person formance evaluation.
responsible for
regulatory Part of the manufacturer’s QMS
compliance

IVDR Article 78:
Post-market Fulfils minimum conditions of qualification
surveillance
system of the Person Within the manufacturer’s organization, except small
manufacturer responsible manufacturers
for regulatory
IVDR Article 15: compliance Permanently and continuously available to the authorized
Person representative
responsible for
regulatory Ensures the requirements for PMS and vigilance are met
compliance

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Element of the
Description MDR IVDR
Regulation

Post-market Part of the QMS and technical documentation

surveillance
Defines indicators and thresholds for
plan
continuousreassessment of risk management and the
risk-benefit analysis
MDR Article 84:
Describes the
Post-market Incorporates information from complaint investigation
implementation
surveillance and market experience
of the PMS
plan
system for Describes methods to monitor trends, identify statistically
collecting significant increases in frequency or severity of incidents
MDR Annex III:
information and and provides trend reports
Technical
characterizing
documentation
the safety and Defines methods of communication with competent
on post-market authorities and notified bodies
performance of
surveillance
the device, or
family of Defines methods of communication with authorized
IVDR Article 79: representatives, importers, distributors, users and patients
devices, and the
Post-market
methods and Describes means of tracing and identifying devices
surveillance
processes to
plan
assess the References the documented procedures for the –
collected
IVDR Annex III: PMS system;
information
Technical
creation of the PMS plan;
documentation
on post-market generation of the PSUR or PMS report, as
surveillance applicable; and
processes for corrections, corrective actions or
preventive actions.

Post-market
surveillance Includes rationale for, and description of, any preventive
report action or corrective actions taken
Summarizes the
MDR Article 85: results and
Updated when necessary and made available to the
Post-market conclusions of
competent authority upon request
surveillance analysis of the
report PMS data

IVDR Article 80:
Post-market Applicable to class I devices Applicable to class A
surveillance and B devices
report

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Element of the
Description MDR IVDR
Regulation

Kept up to date throughout the lifetime of the device

Part of the technical documentation

Includes –

conclusions to be used in risk–benefit

determination;

main findings of any PMCF/PMPF

evaluation report;

volume of sales of devices with an estimate of

Period safety the size of the population using the device; and
update report
Summarizes rationale for, and description of, any preventive
the results and action or and corrective actions taken.
MDR Article conclusions of
86: Periodic the analysis of
safety update PMS data with
report usage data
Class IIa devices

IVDR Article Updated when

81: Periodic necessary and at
safety update least every two years
report

Class IIb devices Class C devices

Updated when necessary Updated when necessary
and at least annually and at least annually

Made available to Made available to

notified body and, upon notified body and, upon
request, to competent request, to competent
authorities authorities

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 Element of the
Description MDR IVDR
Regulation

For implantable devices

Submitted electronically
by means of Eudamed2 to
notified body

Notified body evaluation

added with details of any
action taken

PSUR and the notified

body evaluation available
to competent authorities
through Eudamed2

Class III devices Class D devices

To update when Updated when necessary

necessary and at least and at least annually
annually
Submitted electronically
Submitted electronically by means of Eudamed2
by means of Eudamed2 to notified body
to notified body
Notified body evaluation
Notified body evaluation added with details of any
added with details of any action taken
action taken
PSUR and the notified
PSUR and the notified body evaluation available
body evaluation available to competent authorities
to competent authorities through Eudamed2
through Eudamed2

2
This will not apply until Eudamed becomes available which may not be on the date of application of the Regulation.

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Element of the
Description MDR IVDR
Regulation

Vigilance

MDR Article 87:
Reporting of
serious
incidents and
field safety
corrective
actions
Exemption rules reduced
MDR Article 88:
Trend reporting Temporary serious deterioration in health reportable

MDR Article 89: Establishes trend reporting

Analysis of
serious Manufacturers must report immediately after they have
incidents and established a causal relationship between that incident
field safety and their device or that such a causal relationship is
corrective reasonably possible, and not later than –
actions
2 days in the case of serious public health
IVDR Article 82:
threats;
Reporting of
serious
10 days in the case of death or unanticipated
incidents and
serious deterioration in health which has
field safety
remained unchanged; and
corrective
actions
15 days for all other events.
IVDR Article 83:
Trend reporting

IVDR Article 84:
Analysis of
serious
incidents and
field safety
corrective
actions

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Actions
All the above points mean that you need to review your existing processes and improve their efficiency
and effectiveness, as well as look at resource needs to implement the changes and then sustain
compliance. You need to develop an effective implementation plan for these changes that are integrated
within your overall programme to move to compliance with all the aspects of the Regulations.

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Get in Touch
Smart Support is designed to outline the impact of the new regulatory changes, in order for your
business to prepare to navigate the transition and implement the new requirements.

Each Smart Support topic is written by an industry expert and reviewed by a topic expert and advisory
panel, providing you with:

An executive summary suitable for senior management

Detailed practical guidance on what has changed and what this means for your organization

Actions to take now and a summary of what is still to change

To access the full text of the MDR/IVDR Smart Support and find
out more about Compliance Navigator, contact us today.

T: +44 (0)20 8996 7029

E: cservices@bsigroup.com
bsigroup.com/complinav

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