THE MEDICAL DEVICE REGULATION (MDR)

The requirements of the MDR became applicable to all medical devices sold in the EU as of 26 May 2021. However, on 15 March 2023, the Regulation (EU) 2023/607 was formalised, which provides medical device manufacturers more time to certify medical devices to mitigate the risk of shortages. The amended regulation introduces a longer transition period to adapt to new rules under the MDR for products already on the market under the MDD/AIMDD.