MDCG Meeting Updates Expected To Break Implementation Silence On EU IVDR

With the impending 26 May deadline for implementing the EU IVD Regulation, it is surprising that there have been no new guidances published for nearly a month now. So what is going on?

Gap (cherezoff/Shutterstock.com)
Hiatus in publication of MDR and IVDR implementation material

After months, indeed years, of almost daily news from the European Commission of developments related to the implementation of the EU’s new Medical Device and IVD Regulations, there has been relative silence for nearly a month now.

Indeed, the last medtech guideline on how notified bodies should oversee legacy medical devices certified under the former Medical Devices Directive or Active Implantable Medical Devices Directive, MDCG 2022-4,...

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