The Medical Device Coordination Group issued a new guidance document:
MDCG 2022-4 – ‘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 AIMDD’
What does the MDCG title mean in plain language?
MDR, Article 120 is for ‘Transitional provisions’. It covers:
which devices are eligible, referred to as ‘legacy’ devices
which aspects of the MDR will apply to legacy devices
how long the transition period lasts
MDCG 2022-4 outlines the requirements for Notified Body surveillance audits for these legacy devices. Therefore, it is a worthwhile read for manufacturers with MDD/AIMDD CE Marking certificates, as this directly impacts you during your next audit.