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Sop Product Certification and Registration

This SOP describes the process for bringing a medical device to market in compliance with regulations. It involves classifying the device, obtaining conformity assessment from a notified body if required, compiling technical documentation including a declaration of conformity, and registering the device with a Unique Device Identifier (UDI).

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16 views

Sop Product Certification and Registration

This SOP describes the process for bringing a medical device to market in compliance with regulations. It involves classifying the device, obtaining conformity assessment from a notified body if required, compiling technical documentation including a declaration of conformity, and registering the device with a Unique Device Identifier (UDI).

Uploaded by

m.monir.sa
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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Docume

nt
Regulatory Requirement Section
MDR Annex I (General Safety and Performance Requirements), Annex IV (EU All
Declaration of Conformity), Art. 27, 29, 31 (UDI / Eudamed)
MPDG §8, §96, §97 All
ISO 13485:2015, Sections 4.2.3 All

Summary
This SOP describes how a medical device is brought to the market while observing
applicable regulatory requirements, including the compilation of a Technical
Documentation and issuing a EU Declaration of Conformity for the medical device.

Process Owner <enter role of process owner>


Key Performance Indicators <enter KPIs to be tracked for the Management Review>

Process Steps
1. Decision on New or Revised Medical Device
This process is initiated once the Management decides to place a new or updated medical
device on the market. Business input could be:
• Conversations with prospective customers
• Market opportunities
• Internal ideas
If applicable, a responsible Product Manager for a new device is appointed. Together with
the QMO, they determine the classification of a new device as part of the MDR Classification
document.

Participants Management, Product Manager,


QMO
Input Management decision on new
device
Output Completed medical device
classification

2. Application for Conformity Assessment by Notified Body


If necessary based on the medical device classification, a Notified Body is involved for the
conformity assessment for the new device.
NOTE: a Notified Body must be involved in the conformity assessment of all
medical devices except for class I.
Participants Product Manager
Input Medical device classification
Output Contract with Notified Body

3. Compilation of Technical Documentation and Declaration of Conformity


The technical documentation for the medical device is compiled by following respective
processes for development (e.g. software development, risk management, usability
testing). The Product Manager is responsible to coordinate this process step with all
relevant members of the organization. Documentation for different versions of the device is
kept separate.
The Product Manager maintains a Medical Devices List according to MDR Annex II Sec 1.2
that provides an overview of:
• Installed product versions per customer site (if applicable)
• Previous device versions, incl. release and decommissioning date
• Similar devices
Prior to submission to the Notified Body for conformity assessment (if applicable), the
QMO checks the documentation for completeness according to the stipulations listed
below. Compliance with EU legislation is documented in the MDR General Safety and
Performance Requirements Checklist.
• MDR General Safety and Performance Requirements (Annex I)
• MDR EU Declaration of Conformity (Annex IV)
After successful approval by the Notified Body, the Management signs the declaration of
conformity. A product (version) is considered released and placed on the market with the
release of its declaration of conformity.

Partici Product Manager, QMO


pants
Input Technical documentation
Output Approval by Notified BodySigned EU Declaration of ConformityUpdated List of
Medical Devices and Product Versions

4. Registration of Medical Device (UDI)


Country-specific requirements for registration are observed before making a new medical
device (version) available in a market. For the European market, the Product Manager
follows the requirements set out in Art. 29 and Annex VI MDR by registering the device’s
Unique Device Identifier (UDI) in the European Database for Medical Devices (Eudamed).
For the implementation of product changes, the Product Manager applies for a new UDI-DI
if the changes entail one of the following:
• A significant change based on the Change Evaluation List
• Changed intended use
• New product features
• Changes in product interoperability, new interface or connected systems
• Non-trivial change to the user interface
• New supported operating system
• New programming language
• New algorithm model
• Non-trivial change to the software or database architecture
The Product Manager assigns a new UDI-PI for modifications such as:
• Bug fixes
• Security patches
• User interfaces (limited to usability and excluding security improvements)
The UDI-PI is determined by the manufacturer. Typically, the device version number serves
as the UDI-PI (see SOP Software Development).
NOTE:
• The Basic UDI-DI (or: BUDI-DI) is assigned by UDI providers and identifies a group
of medical devices with the same purpose, risk class, comparable design and
manufacturing features.
• The UDI-DI is assigned by UDI providers for each medical device product type
and is revised for any major modifications (substantial updates) to the device.
• The UDI-PI you can assign yourself as a manufacturer for every single product and
is revised for minor modifications (non-substantial updates).
Example:
• Basic UDI-DI: Wrist-band health tracking device
• UDI-DI: different code based on color and packaging (white/blue/red;
single-/double-pack)
• UDI-PI: different code based on series/batch/version, expiration date, etc.
NOTE: As of early 2021, the European Commission has designated four entities to
issue UDI codes: GS1, HIBCC, ICCBBA and IFA. As long as Eudamed is not set up
for registration, national registration requirements apply. For Germany, consider
§96 and §97 of the MPDG. At OpenReg, we recommend obtaining a UDI already to
be prepared for the regulatory transition.
NOTE: As part of the registration process, authorities in non-EU countries may
require the documentation to be provided in other languages. Consider norms
and regulations for the translation of medical device documentation.
Participants Product Manager
Input Released Declaration of Conformity
Output Updated or new UDI Completed
device registration

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Please don’t remove this notice even if you’ve modified contents of this template.

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