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.
The EU Batteries Regulation is yet another legal instrument medical device manufacturers must address over the coming years alongside the core Medical Device and IVD Regulations.
IVD manufacturers look set to be granted up to 18 more months to comply with the EU IVD Regulation very soon.