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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