EU Advice On How To Implement A UDI Plan Into A Quality Management System
The MDCG has illustrated how medtech manufacturers should implement UDI into their quality management systems in the context of the Medical Device and IVD Regulations.
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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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