New IVDR Notified Body Named After A Nine-Month Gap
A new EU notified body has been designated under the IVD Regulation after nine months of an absence of news; but another hiatus is likely now until October.
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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 highest risk IVDs are due to receive an extra layer of regulatory scrutiny in the EU. But it is taking a long time to set up the structures needed.
While each new designation of a notified bodies in the medtech space is good news, many more organizations are needed rapidly to help manage growing demand. Capacity warnings continue.