Europe – MDCG 2020-3 : Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD

Article 120(2) and 120(3) of the Medical Device Regulation (EU) 2017/745 (MDR) states that devices which have a valid certificate 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 and no later than 26 May 2024.
Questions 8 and 9 of the CAMD Transition Sub Group guidance: “FAQ – MDR Transitional
provisions, V1.0 of 17. January 2018” state that the certificates covered by MDR Article 120(3) include “all certificates which are commonly issued by notified bodies with reference to the Council Directives MDD and AIMDD”.

Conditions referred to in the first paragraph require that no significant changes in design or
intended purpose of a device be performed after the date of application of the MDR. Therefore, it is important for manufacturers and notified bodies to get clarity on the significant changes to be considered under MDR Article 120(3).

It is also important that the AIMDD and MDD certificates remain valid following changes that are not significant with regard to design or intended purpose, provided that the required surveillance is carried out by the notified body that issued the certificate. See also Question 17 of the above mentioned CAMD guidance…