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.
TÜV SÜD continues to strongly encourage manufacturers to act now, despite the new MDR timelines. The procedure of the EU MDR is known to be complex and sometimes requires longer processing times. TÜV SÜD has, at an early stage and steadily, built up capacities and is in constant close exchange with manufacturers on the changeover. However, manufacturers must also become active in the new situation and work at full speed on the planning, to avoid any delays at the end of the transition timelines.
The infographic below details the key changes and latest MDR timeline in a concise manner.