Europe – MDCG 2022-4 Rev.1 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 (Revised)

Article 120(2) and 120(3) of the Medical Device Regulation (EU) 2017/745 (MDR) state that
devices which are covered by valid certificates issued by a notified body under the Active
Implantable Medical Devices Directive 90/385/EEC (AIMDD) or the Medical Devices Directive 93/42/EEC (MDD) may be placed on the market1 or put into service2 after the date of application of the MDR and no later than 26 May 2024 under certain conditions.
The abovementioned conditions require that the notified body that issued the certificate under the MDD or the AIMDD continues carrying out appropriate surveillance in respect of all of the applicable requirements relating to the devices it has certified. Therefore, it is important for manufacturers, notified bodies and national authorities to get clarity on activities to be part of the appropriate surveillance referred to in Article 120(3) of the MDR…