REGULATION (EU) 2023/607 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices
New transitional deadlines for Medical Devices under the Medical Devices Regulation (MDR) :
– Higher risk class III and class IIb devices to 2027 instead of May 2024 at the latest.
– Class 1 devices (which need a NB certificate under MDR) to 2028 instead of 2025
– Class IIa devices to 2028 instead of May 2024 at the latest.
– Removal of the “sell off” date of May 2025 under both MDR and the In Vitro Diagnostic Devices Regulation (IVDR).