Europe – 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

Article 120 of the Medical Device Regulation (EU) 2017/745 (MDR), as amended by Regulation (EU) 2023/6071, states 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 market3 or put into service4 after the date of application of the MDR under certain conditions until :
(a) 31 December 2027, for all class III devices, and for class IIb implantable devices
except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges,
plates, wires, pins, clips and connectors;
(b) 31 December 2028, for class IIb devices other than those covered by point (a) of this
paragraph, for class IIa devices, and for class I devices placed on the market in sterile
condition or having a measuring function.

The above mentioned conditions require, among others, that a notified body, either the one that issued the certificate under the MDD or the AIMDD or the one with which the manufacturer has signed the written agreement for MDR certification (see section 4.1), continues carrying out appropriate surveillance in respect of all of the applicable requirements relating to the legacy devices7 which are subject to the surveillance requirements according to Article 120(3e)…