Device/Drug Borderline: Gray Areas Remain Despite New EU Guidance
The regulation of products on the drug/device borderline has always been complex. New EU guidance aims to provide clarification, but some difficult and nuanced decision-making is still left to the manufacturer.
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MDR And IVDR – Similar Step Ups, Varying Commercial Impacts
Medtech Insight spoke to the CEOs of two companies that recently had very different experiences with the new European IVDR and MDR regulations to gauge their thoughts on any potential commercial impacts.
Why Adding A Legacy Device To Eudamed Now, Before It is Mandatory, Is A Shrewd Move
The EU MDR amending regulation does not impact Eudamed directly, but it may make medtech manufacturers reconsider when to register legacy devices in Eudamed. Richard Houlihan of EirMed explains.