Notified Body Coordination Group - Medical Devices

NBCG-Med

https://health.ec.europa.eu/medical-devices-dialogue-between-interested-parties/overview This group allows notified bodies to share experiences and exchange points of view on the application of conformity assessment procedures. Develops technical recommendations and builds consensus on issues related to conformity assessment. Advises the Commission, at its request, on medical device legislation. Prepares reports on ethical aspects of the activities of notified bodies. It ensures consistency with the standardization work carried out at European level.

Lobbying Activity

Meeting with Flora Giorgio (Head of Unit Health and Food Safety) and The European Association of Medical Devices – Notified Bodies

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.