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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The EU must keep its medtech regulation under review as rapidly changing technology and external market factors may be challenging the operability of some aspects of the new medtech regulations, especially for less mature businesses and SMEs. Legal medtech expert, Shuna Mason, of CMS explains why.
Latest information from the European Commission suggest that future notified bodies designated under the MDR, and even the IVDR, may not be in a position to issue certificates until March 2023.
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