The Medical Device Coordination Group (MDCG) has revised its “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”.
The document intended for notified bodies, but is nevertheless is valuable to read for other interested parties as it provides additional clarification on important aspects for the extended transition period of legacy devices.
Manufacturers may only make use of the extended transition period under certain conditions. For example, manufacturers must have formally applied for MDR conformity assessment until May 26, 2024 and signed an agreement with an MDR designated notified body for the conformity assessment until September 26, 2024.
In this context, notified bodies must maintain surveillance of the legacy devices. Confusion may come up if a manufacturer changes the notified body in the transition to the MDR. In this case, the guidance makes clear: “If the notified body that issued the MDD or AIMDD certificate is not designated under the MDR, its responsibility for the appropriate surveillance will end on 25 September 2024, at the latest. No later than 26 September 2024, the notified body with which the manufacturer has signed the written agreement for MDR certification will be responsible to carry out this appropriate surveillance […].”
These and other points are laid out and further explained in the document. Manufacturers are recommended to read the paper as it provides clarity on certain aspects of the transition period.
Should you require the document or additional advice, please don’t hesitate to get in touch.
Source: European Commission