Team-NB Position Paper: Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical Device Regulation (EU) 2017/745 (v3)

Team-NB published an updated version of its Position Paper “Best practice guidance for the submission of technical documentation under Annex II and III of Medical Device Regulation (EU) 2017/745”. It aims to provide a clear and harmonized framework for presenting the technical documentation for medical devices in line with the MDR, in order to facilitate assessment by notified bodies.

In particular, this document covers:

• Key requirements for each MDR annex (in particular Annexes II and III);
• Good practices for improving dossier legibility and traceability;
• Concrete examples to illustrate expectations.

This Position Paper helps manufacturers to efficiently structure their technical documentation according to the MDR, by clarifying the common expectations of notified bodies. Through this practical information, this document aims to streamline the technical documentation submission.

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