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European Commission Sheds Light On MDR/IVDR Progress In Vital Update

Executive Summary

A new "rolling plan" provides deadlines for implementing actions, and other efforts, that are necessary to get the new EU Medical Device and IVD Regulations off the ground.

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Rolling On: EU Makes Good Progress On Structures For New Regs Implementation

The European Commission has updated its EU MDR and IVDR implementation Rolling Plan to reflect the latest developments on the much-needed structures for implementing the new Regulations. The most recent update addresses UDI, Eudamed and Common Specifications for high-risk class IVDs.   

Brexit No Certain Thing For European Medtech Groups Desperate To Plan Futures

Medtech stakeholders were reminded at the UK's largest regulatory forum that, for business in general, and medical technology manufacturers in particular, those willing to make the best of Brexit are still having to work in the dark. The lack of useful government outreach is frustrating most efforts to secure business continuity. And that is without factoring in the huge regulatory changes that the EU's twin medical device regulations – the MDR and IVDR – will bring.

Brexit + MDR Equals Little Certainty For UK And EU Medtech Groups

Medtech stakeholders were reminded recently at the UK's largest regulatory forum that even those willing to make the best of Brexit are still working in the dark. The lack of useful government outreach is frustrating most efforts to secure business continuity. And that is without factoring in the huge regulatory changes that the EU's twin medical device regulations – the MDR and IVDR – will bring.

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