EU: Revised Device Surveillance Guidance

The Medical Device Coordination Group (MDCG) issued a second revision to its surveillance guidance for medical devices. The changes align the guidance with EU regulations on transitional provisions for certain medical devices and in vitro diagnostic devices (IVDs).

The document addresses the transition periods according to Article 120 of the Medical Device Regulation (MDR), covering devices certified under the old Medical Devices Directive (MDD) or the Active Implantable Medical Devices Directive (AIMDD). For all class III devices, and for certain class IIb implantable devices the transition period ends on 31 December 2027. For class IIb devices other than those covered by the previous point, for class IIa devices, and for class I devices placed on the market in sterile condition or having a measuring function the transition period ends on 31 December 2028.

The guidance specifies that appropriate surveillance applies only to "legacy devices" with MDD or AIMDD certificates. Devices not requiring a notified body under MDD are exempt from surveillance under Article 120, even if MDR requires it.

If the notified body that issued the MDD or AIMDD certificate is not MDR-designated, surveillance responsibility ends on 25 September 2024. After this date, the responsibility shifts to the notified body with which the manufacturer has an MDR certification agreement.

Source:

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