80% Of MDR Device-Related Codes Are Offered By Over 20 Notified Bodies
An update is now available from the European Commission on notified body testing capacity according to product type codes.
You may also be interested in...
The entire medtech sector is all too aware of the lack of capacity among notified bodies to support the EU medical device and IVD regulations. But what really matters is how much notified body capacity there is in a given product area as this will have the most influence on conformity assessment timelines for individual products.
The European Commission’s proposal to extend transition timelines for legacy devices in the context of the Medical Device Regulation is already on the move. There are still questions, however, about whether a fast-track adoption is in the best interests of the medtech sector.
A review of expert panel opinions related to high-risk medical devices shows no challenges yet by notified bodies to their findings.