Technical Documentation for medical devices under the new EU MDR Regulations.
Under EU MDR Regulations manufacturers need to establish and maintain a EU MDR Technical Documentation as an evidence of conformity with the relevant legislation.
Although medical devices can still be placed on the market under the provisions of the MDD/AIMDD as indicated in Article 120 MDR after 26 May 2021 under certain circumstances, manufacturers should prepare to update their Technical Documentation to MDR as per the EU MDR Regulation. This is also true for manufacturers of class I devices that are not provided sterile, have no measuring function and are not reusable surgical instruments even though no involvement of a Notified Body is required.
Though the relevant annex for the Technical Documentation according MDR is Annex II and Annex III, you should be aware that other articles and annex need to be taken into consideration.
The Technical Documentation is for example heavily interwoven with Annex I (GSPR), and also the conformity assessment according to Annex IX to XI include requirements applicable to the Technical Documentation.
Annex II of the EU MDR Regulation shows that the requirements for the Technical Documentation have been increased compared to the MDD, but they are now also outlined in a clearer way. One change that might affect your Technical Documentation is the post-market surveillance (PMS): While products on the market have already PMCF data, user feedback, complaints and/or competitor analysis data available, new devices first need to establish these PMS data. Nevertheless, it needs to be shown how this data will be generated. The data may consist of the manufacturers post-market surveillance plan (which might include a planned PMCF study), but should also include vigilance data from competitors already.
Structure of Technical Documentation
The regulatory requirements do not specify how manufacturers should structure the technical documentation.
One of the best known proposals for structuring technical documentation comes from the IMDRF (formerly the GHTF). A lot of authorities and notified bodies use the STED (Summary Technical Documentation) as a guide.
Annex II of the new EU MDR prescribes more than forty specific elements for the content of the (primary) “EU MDR Technical Documentation”. Plus Annex III of the EU MDR requires more than fifteen additional elements in the “Technical Documentation on Post Market Surveillance”.
Article 10 of the EU MDR makes the creation and maintenance of both parts of the EU MDR Technical Documentation an obligation of all Manufacturers. The Technical Documentation is to be supplied to Competent Authorities when requested. A copy is also to be kept by Authorized Representatives (EU MDR Article 11). It is also one of the items the “Person responsible for regulatory compliance (PRRC)” has to ensure is kept up to date (EU MDR Article 15) and it is to be assessed by the Notified Body (EU MDR Annex IX chapter II). In contrast to the MDD, the new EU MDR Regulations are consistent throughout on the subject of the EU MDR Technical Documentation.
The (primary) Technical Documentation of Annex II of new EU MDR Regulations clearly based on the so called summary technical documentation or STED, developed by the former Global Harmonization Task Force (GHTF)
Content of technical documentation as outlined in Annexes II and III of the MDR
|Annex II||Technical Documentation|
|1||Device description and specification, including variants and accessories|
|1.1||Device description and specification|
|1.2||Reference to previous and similar generations of the device|
|2||Information to be supplied by the manufacturer|
|3||Design and manufacturing information|
|4||General safety and performance requirements|
|5||Benefit–risk analysis and risk management|
|6||Product verification and validation|
|6.1||Pre-clinical and clinical data|
|6.2||Additional information required in specific cases|
|Annex III||Technical Documentation on Post Market Surveillance|
|1||The post-market surveillance plan|
|2||The PSUR (Periodic Safety Update Report)|
In all conformity assessment procedures involving a NB, a review of the EU MDR technical documentation is mandatory. Article 52 of the EU MDR provides details on the conformity assessment procedures, which are further set out in Annexes IX–XI, depending on the device.
The sampling rate applied during audit by your NB is dependent upon the device classification, as detailed in the following list:
For class I devices, which are not provided sterile, have no measurement function and are not reusable surgical instruments, NBs are not involved in conformity assessment. For such devices, manufacturers shall ‘declare the conformity of their products, by issuing the EU declaration of conformity referred to in Article 19 after drawing up the technical documentation set out in Annexes II and III’ (Article 52, point 7).
Requirement as per EU MDR Regulations
Information to be supplied
Design & Manufacturing Information
General Safety & Perfomance Requirements
Benefit-Risk Analysis and Risk Management
Product Verification and Validation
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