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EU MDR Panel Discussion: Why An Extra Year Is Not Really A Delay For The MDR – How To Survive Changing And Confusing Times

 
• By Amanda Maxwell

26 May 2020, the date that the Medical Device Regulation was originally due to apply in the EU, was a good time to take stock of where the medtech sector finds itself. Three of the most renowned and outspoken experts on the EU medical device regulatory system gave their views in this exclusive interview.

Exclusive interview Q&A KOI

The one-year delay in the application of the EU Medical Devices Regulation (MDR), until 26 May 2021, does not offer as many flexibilities as it seemed to promise, and neither does it span a whole year. Some who play an important role in the sector still seem unaware that a postponement has even been formally agreed.

With so many recent changes and a backdrop of uncertainty, confusion and shifting requirements, Bassil Akra of TÜV-SÜD notified body, Gert Bos of Qserve consultancy and Erik Vollebregt, of Axon Lawyers, all agreed that “a year extra is not a

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