MDCG 2022-4 Rev.2 : Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD

Legacy devices with valid EC certificates issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC may continue to be placed on the market or put into service beyond the implementation date of Regulation 2017/745 and until 26 May 2024 at the latest, in accordance with Article 120 (Transitional provisions) of the Regulation.

Article 120 (3) 2nd paragraph of the Regulation specifies that “the notified body that issued the certificate […] shall continue to be responsible for the appropriate surveillance in respect of all of the applicable requirements relating to the devices it has certified.”

MDCG 2022-4 provides clarifications on these specific surveillance activities for legacy devices to be carried out by Notified Bodies.