EU Now Boasts Of 30 Notified Bodies Under The Medical Device Regulation
The landmark figure of 30 notified bodies designated under the MDR has now been reached. But more are needed.
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Medtech Insight spoke to the CEOs of two companies that recently had very different experiences with the new European IVDR and MDR regulations to gauge their thoughts on any potential commercial impacts.
The latest designation of a notified body in the context of the MDR means that the EU only needs one more to make the landmark total of 30. It seems that this may be realized soon.
The revised timelines around products generally used for aesthetic purposes, a small subset of products falling under the Medical Device Regulation, create their own microsphere of complexity.