European Commission Proposal To Free Up Notified Body Time And Extend Reassessment Deadlines
The EU is in urgent need of more notified bodies to test medtech products under the Medical Device and IVD Regulations. The commission is taking steps to free up everyone’s time.
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This new listing is the tenth Italian notified body under the Medical Device Regulation, bringing the total number of notified bodies to 36.
Amending the MDR to stem the flow of medtech products being withdrawn from the market has long been seen as urgent. It looks like the EU is keeping its foot on the accelerator to adopt its latest proposal despite concerns raised about the text.
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.