The European Association of Medical Devices – Notified Bodies | Open Lobby EU

The European Association of Medical Devices – Notified Bodies

Team-NB

The Association, is a non-profit association, with the objective to represent the European Notified Bodies for Medical Devices in their dealings with all the stakeholders of the sector; namely the European Commission, Competent Authorities of Members States, associations of the medical devices industry and with the media.

Links

Website Transparency Register Profile

ID: 731188910513-57

Lobbying Activity

Response to Digital Omnibus revising several legislative acts in view of regulatory simplification

14 Oct 2025

Response to Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices as regards simplification and burden reduction

6 Oct 2025

Meeting with Lorena Boix Alonso (Deputy Director-General Health and Food Safety) and

31 Jul 2025 · Exchange of views on the state of play and next steps for the medical devices sector.

Response to COMMISSION IMPLEMENTING REGULATION (EU) …/... laying down, pursuant to Regulation (EU) 2021/2282 on health technology assessment, procedural rules for the interaction during, exchange of information on, and participation in, the preparation and update of joint clinical assessments of medical devices and in vitro diagnostic medical devices at Union level, as well as templates for those joint clinical assessments

25 Jun 2025

Response to Apply AI Strategy: strengthening the AI continent

4 Jun 2025

Meeting with Flora Giorgio (Head of Unit Health and Food Safety) and Notified Body Coordination Group - Medical Devices

17 Feb 2025 · Opportunities for the improvement of harmonisation and predictability of conformity assessment procedures under MDR / IVDR. Involvement of Commission representatives during the NBCG-Med plenary meeting planned in April 2025.