Whether the new proposal from the European Commission to delay the EU Medical Device Regulation (MDR) transition period works out will depend on the development of new guidances, according to experts who spoke to Focus. They also said that manufacturers need to take advantage of the extension and not wait till the last minute to submit their applications.
Over the past year, stakeholders have voiced grave concerns that the deadline for manufacturers to transition from the previous medical device directives to the MDR will force tens of thousands of products off the European market and endanger patients. One of their chief concerns has been the lack of notified body capacity to review all the products that need to transition to the new regulations.
Heeding those concerns, the European Commission on 6 January adopted a proposal to extend the MDR’s transition period to 2027 or 2028, depending on the risk level of the device. The Commission also proposed repealing the “sell-off” date provision under MDR and the In Vitro Diagnostic Medical Devices Regulation (IVDR). (RELATED: European Commission moves to delay MDR transition, Regulatory Focus 6 January 2023)…
