Notified bodies (NB) say that while extending the deadline to transition to EU Medical Device Regulation (MDR) has been a positive move, there is more regulators and industry can do to ensure manufacturers can recertify their products on time.
Over the past year, it became apparent to regulators, NBs, and other stakeholders that there was not enough time for many medical devices to transition from the Medical Device Directive (MDD) to MDR. As a result, transition deadlines were extended earlier this year, but NBs argue that more could be done to prevent potential device shortages in the coming years (RELATED: Council votes unanimously to extend MDR deadlines, Regulatory Focus 7 March 2023).
“Notified bodies welcome the generous extension of the transition timelines and are confident that they could transition all remaining certificates within the given timeframe,” Team-NB wrote in a white paper published 10 August. “However, it is not just up to notified bodies to facilitate a successful transition.”…
