MDD

Standards

Are Harmonised Standards facing irrelevance?

There’s been considerable disquiet over the lack of availability of harmonised standards to support the new European Medical Device Regulations (MDR).  And rightly so. But harmonisation is already in disarray...
Transition

Make your transition from MDD to MDR – White Paper

With less than one year remaining for the transition to the Medical Device Regulation (MDR), this white paper takes a look at the key areas to be addressed for manufacturers...
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Europe’s pragmatic approach to clinical evidence for legacy devices – or why the devil is always in the detail…

Regulatory affairs demand attention to detail. So when the European Medical Devices Coordination Group released document MDCG 2019-3 - Interpretation of Article 54(2)b we regulatory geeks just knew we should...

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