EC updates Guideline 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
28 May 2024
On 27 May 2024, the European Commission published a new update (Revision 2) of the MDCG 2022-4 Guideline. This guideline describes the activities required of notified bodies, as well as manufacturers, as part of the appropriate monitoring of the transitional provisions under Article 120(3) of the MDR, concerning devices covered by certificates under the MDD and IVDD.
The entire document has been adapted in revision 2 to Regulation (EU) 2023/607 of the European Parliament and of the Council of March 15, 2023, amending Regulations (EU) 2017/745 and (EU) 2017/746 regarding the transitional provisions for certain medical devices and in vitro diagnostic medical devices.
A short reminder:
According to Article 120 of the MDR, medical devices may continue to be placed on the market or put into service even after the date of entry into force of the MDR (transitional period until May 26, 2024) if they are certified and continuously being monitored by the notified body to ensure their compliance with the regulatory requirements in place and if no significant changes have been made to their design and intended use.
