French Notified Body Anticipates UK Designation By Summer 2022
After the shake-up of notified bodies based in the UK in the wake of Brexit, GMED is one EU notified body that is hoping for its UK subsidiary to be designated as a UK approved body − within the next six to nine months.
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Updates and speculation surrounding the Eudamed medtech database has attracted significant attention in November. It was also an impactful month for IVDR news too, and for moves strengthening the medtech and pharma interface.
The European Commission has published an Implementing Regulation explaining some of the fundamental practices that need to be carried out by different actors from the beginning for Eudamed to operate successfully.
Every new notified body designation under the Medical Device Regulation is being welcomed by medtech companies as the countdown continues for the grace period to end in May 2024.