Medical device CE marking

MDCG revised guidance 2022-4

2022-12

The MDCG revised guidance 2022-4 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.

Revision 1:
Adjustments all over the document to align it to MDCG 2022-15 and to reflect the views of MDCG as expressed in action n.3 of MDCG 2022-14.

MDCG 2022-4 discusses:
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 market or put into service after the date of application of the MDR (26 May 2021) 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 with respect to all 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.

To appropriately address application of transitional provisions to devices covered by certificates according to MDD or the AIMDD, this guidance, drafted in line with MDCG 2021-25 on application of MDR requirements to ‘legacy devices’, should be read in conjunction with guidance MDCG 2020-3 on significant changes.

The document discusses following topics:
– Requirements in respect to the manufacturer’s quality management system and related obligations
– Surveillance according to Article 120(3) MDR
– Possible scenarios for the surveillance according to Article 120(3) MDR

The updated guidance can be downloaded from our library

Source: European Commission