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One More EU MDR Notified Body In The Pipeline And Then A Gap

 
• By Amanda Maxwell

With major concerns persisting over notified body capacity under both the EU medical device and IVD regulations, every new designation is important. The numbers continue to nudge up slowly.

A man looking through the binoculars
When can the medtech sector expect more notified body designations?

Latest notified body figures from the European Commission, published just ahead of the official designation of Berlin Cert under the Medical Device Regulation, suggest that there is one more designation in the immediate pipeline under the MDR, which has been in force for over a year, but none for some time under the IVD Regulation which applied as of 26 May.

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