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Stack Of New And Revised EU MDR and IVDR Guidances In The Pipeline

 
• By Amanda Maxwell

The EU has published a lengthy list of new guidances to be drafted as well as existing guidance documents that need updating in the context of its MDR and IVD medtech regulations, including covering the interpretation of the Medical Device Regulation wording on “significant changes.”

guidance advances
• Source: Shutterstock

The public list of ongoing guidance development and deliverables for the European Commission’s Medical Device Coordination Group (MDCG) subgroups has been greatly expanded.

As well as featuring many new documents in the context of both the Medical Device Regulation and the IVD Regulation,...

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