Precision in Pleadings

Published 19 April 2023

The implementation of EU Regulation 2017/745 on Medical Devices (“the MDR”) has been the subject of some debate. The MDR currently provides for a transition period for the re-certification of medical devices until 26 May 2024, when prior European Conformity certificates will become void.

The European Commission has recently proposed to extend the transition period set out in the MDR for devices certified in accordance with the Medical Device Directive (“MDD”) and the Active Implantable Medical Device Directive (“AIMDD”) through legislative amendment of the transitional provisions of the MDR. It is suggested that the extension of the transition period would take a staggered approach based on the risk classification of relevant devices.

The European Commission has, at its meeting of the Employment, Social Policy, Health and Consumer Affairs Council on Friday, 9 December 2022, proposed a number of targeted legislative amendments. It has been suggested that there would be an extension of transitional provision set out in the MDR, based on the risk class of a relevant device. The Commission has suggested that the deadline for recertification for a Class III and Class IIb medical devices would be extended to 2027 and to 2028 in respect of Class IIa and Class I medical devices. It has also been proposed to remove the sell-off provision and deadline of 26 May 2025 for medical advices that are already available in the European Market to prevent the safe medical devices already on the market from being removed.

The Commission has noted in its proposals that applications for extensions would only be available to medical devices that do not pose an unacceptable risk to patients; that have not undergone significant changes in design or intended purpose; and, where manufacturers have already taken the necessary steps to launch certification under the MDR, submission and/or acceptance of manufacturer’s application for conformity assessment by a Notified Body before (for example) the current transition deadline.

The Medical Device Coordination Group has also published a position paper on the transition period, proposing that manufacturers could benefit from an exemption pursuant to Article 97 for a temporary period. However, the proposed exemption is only available in certain specified circumstances.

Moreover, no significant guidance has been provided, by either body, in respect of the In Vitro Diagnostic Regulation.

It has been suggested that the European Commission will undertake a full evaluation of the MDR by May 2027. This review will consider any structural issues which have arisen and the potential solutions to those issues. It is further suggested that the Commission will fund actions to support the implementation of the MDR under the EU4Health programme starting in early 2023.

Further clarity on the implementation and transition period of the MDR is to be welcomed, although it is far from clear that the issues arising have been resolved.