Revised MDCG 2022-4 on ‘Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR’

Revised MDCG 2022-4 on ‘Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR’

In May 2024, the Medical Device Coordination Group (MDCG) endorsed the revised version of the document MDCG 2022-4 rev.2. This provides guidance on appropriate surveillance regarding the transitional provisions under Article 120 of Regulation (EU) 2017/745 on medical devices (MDR) with regard to devices covered by certificates according to the previous Directives 93/42/EEC (MDD) or 90/385/EEC (AIMDD). The document was revised to take into account provisions introduced by Regulation (EU) 2023/607 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices.

For more, see the Commission’s webpage on Guidance.