6/7 February 2024
One of the most important documents in the context of medical device regulation is the technical documentation. The requirements for this technical documentation are described on just over 3 pages in Annex II of the Medical Devices Regulation 2017/745. Further, Annex III describes the requirements for a technical Documentation for post-market surveillance (1 page).
For the technical documentation as described in the above mentioned Annex II and III, there is a helpful position paper of the Team Notified Body as a best practice guide. This provides a coordinated approach to the expectations of Notified Bodies with regard to technical documentation. The document was reissued in April as version 2.
The document interestingly starts with the most common deficiencies Notified Bodies found in technical documentation. These are:
To remedy this situation, the position paper has been prepared and provides practical tips:
Following the document, which comprises a total of 47 pages, provides very specific guidelines for the implementation of a technical documentation with regard to
Conclusion: The Best Practice Guide provides coordinated assistance for the preparation of technical documentation for medical devices.