Time For Talking: MedTech Europe Wants Clarity And Transparency Over MDR Amendment

The MDR amending regulation is on the cusp of being enforced. Most feel it is long overdue to prevent further medtech regulatory chaos in the EU. But the new text raises many questions itself. Medtech Insight spoke to MedTech Europe’s Petra Zoellner to understand what is needed next.

Close-up Of Businessperson Checking Bills With Magnifying Glass

There is a need for pragmatism around the implementation of the MDR amending regulation, Petra Zoellner, newly appointed director of industrial policies IVDR-MDR at MedTech Europe said during an interview.

Speaking to Medtech Insight, she noted how it is vital that notified bodies and competent authorities are aligned when it comes to conditions for accessing the new 2027/2028 extended transition...

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