[CE, EU] Revision 2 of MDCG 2022-4 on MDR Appropriate surveillance

 

1. Introduction

Article 120 of the Medical Device Regulation (EU) 2017/745 (MDR), as amended by Regulation (EU) 2023/607, 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 market or put into service 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 abovementioned 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 devices which are subject to the surveillance requirements according to Article 120(3e). Therefore, it is important for manufacturers, notified bodies and national authorities to get clarity on activities to be part of the appropriate surveillance referred to in Article 120(3e) of the MDR.

 

To appropriately address application of transitional provisions to devices covered by certificates according to the MDD or the AIMDD, this guidance should be read in conjunction with guidance MDCG 2020-3 Rev. 1 on significant changes.

 

This revision of the document is in line with the MDCG position reported in MDCG 2022-14, action n.3.

 

For the purpose of this document, ‘legacy devices’ should be understood as devices, which, in accordance with the transitional provisions established in Article 120 of the MDR, are placed on the market after the MDR date of application (26 May 2021) and no longer than the dates reported in the first paragraph above if certain conditions are fulfilled.

 

 

Revision 2 of MDCG 2022-4 on MDR Appropriate surveillance - European Commission (europa.eu)

Revision 2 of MDCG 2022-4 on MDR Appropriate surveillance

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