Guidance on appropriate surveillance regarding the transitional provisions under MDR Art.120 revised
12 January 2023
The Medical Device Coordination Group (MDCG) has issued a revision of the 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 the AIMDD”. Adjustments were made all over the document to align it to MDCG 2022-15 “Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD” and to reflect the views of MDCG as expressed in action n.3 of MDCG 2022-14 “MDCG Position Paper- Transition to the MDR and IVDR – Notified body capacity and availability of medical devices and IVDs”. In action n.3 the MDCG calls on notified bodies to make full use of the flexibility described already in MDCG 2022-4 on ‘appropriate surveillance under Article 120(3) MDR’ with regard to ‘appropriate surveillance’ of legacy devices.
Article 120(2) and 120(3) of the Medical Device Regulation (EU) 2017/745 (MDR) state 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 and no later than 26 May 2024 under certain conditions.
The abovementioned conditions require that the notified body that issued the certificate under the MDD or the AIMDD continues to carry out appropriate surveillance in respect of all of the applicable requirements relating to the devices it has certified. 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(3) of the MDR.
The MDCG 2022-04 Rev.1 guidance document outlines the activities to be performed by notified bodies as part of the appropriate surveillance defined in Article 120(3) second subparagraph MDR. In order to clarify elements to be verified by notified bodies, the guidance document also covers requirements concerning certain manufacturers’ obligations, especially in respect to their quality management system.
The document applies to notified bodies that have lawfully issued certificates under the MDD or the AIMDD, regardless of whether or not those notified bodies have applied for designation or are designated under the MDR (see MDCG 2019-10 rev.1) as long as the respective authority responsible for notified bodies has the right to and does monitor notified body’s activities under Article 120(3) MDR.