In October 2022, Team-NB published several position papers. The first position paper concerns the technical documentation to provide to Notified Bodies, whereas a second one addresses the Transfer Agreement in case of voluntary change of a Notified Body.
Team-NB is the European Association for Medical devices of Notified Bodies.
BPG (Best Practice Guidance) Technical Documentation
In this position paper published at the beginning of October 2022, the NB-Team focused on Technical Documentation. Particularly, the document, namely “Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical Device Regulation (EU) 2017/745″, includes important information that manufacturers should supply when applying to a Notified Body. In April 2023, Team NB published an updated version of “Best Practice Guidance for the Submission of Technical Documentation under MDR”.
The document aims at improving the timing and the quality of the documents that manufacturers provide for the conformity assessment of medical devices. Especially, this can be achieved by developing a unified approach on the expectations of such documentation.
In the position paper on Transfer Agreement, the NB-Team published their proposal for the agreement. In detail, the agreement concerns the terms of voluntary change of notified body under (MDR and IVDR).
Specifically, the sections covered by the template are the following:
- Agreement conclusion and amendments
- Validity of certification subject to transfer
- Assessment prior to transfer
- Confidentiality and obligation to provide information
- Continued certification
- Settlement and property rights
Find all most recent position papers in our Library of Documents.