Certificates Issued Under EU's Medical Device Regulation Leap By Nearly A Third In Just Three Months

The big question in the EU is whether there is sufficient bandwidth among notified bodies to complete the assessment of all necessary devices under the Medical Device Regulation before their legacy certificates expire. The European Commission is watching the situation carefully.

MT1808_Magnifying Glass_377282281_1200.jpg — Identifying Any Shortfalls Or Gaps In EU Testing Capacity • Source: Shutterstock

Nearly 4,000 conformity assessment certificates had been granted by notified bodies in the context of the EU’s Medical Device Regulation (MDR) as of the end of June 2023, an increase of 32% on those granted by end of March 2023.

That is according to latest figures from the European Commission.