On 9 April 2025, the Association of Notified Bodies adopted the updated 3rd version of the notified bodies BPG harmonized approach to clarify information to be submitted by the manufacturer in their technical documentation.
The 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” 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:
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.
You can download the full document here.
