Spanish AEMPS Latest To Gain Notified Body Designation Under EU Medical Device Regulation
At last, Spain has its first notified body under the MDR.
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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.
The first seven months of 2022 have seen significant progress on documents, tools and new structures needed for the MDR and IVDR implementation. But with major hurdles ahead, in July it was still the problems and not the successes taking centre stage