14. joulukuuta 2022

European Council support to delay MDR deadlines

European Counsil supports European Commission's proposal to delay the transitional deadlines for medical devices under the Medical Devices Regulation (MDR). According to the proposal, the deadline for the transition period for high-risk class III and IIb products would be moved to 2027, and for lower-risk class I and IIa products to 2028. The justification for extending the transition periods is in particular the insufficient capacity of the notified bodies - the conformity assessment of thousands of products is still in progress, and not all of them have time to be approved in accordance with the current MDR requirements within the framework of transition schedules.