Partner, James Tumbridge and Associate, David Pountney explore the latest proposal from the European Commission to delay Medical Device Regulation.
The European Commission has announced that it is preparing a proposal to delay the implementation of Regulation (EU) 2017/245 on Medical Devices, (the ‘MDR’) by one year due to the coronavirus pandemic. The move follows recent lobbying by the trade association MedTech Europe and an open letter to the Commission from six members of the European Parliament.
If approved, the delay will come as welcome news to medical device manufacturers who have been stretched by the current crisis, and who are experiencing unprecedented demands for certain equipment during the crisis at the same time as logistical problems with their supply chains. The delay will also relieve pressure on national health and regulatory authorities and Notified Bodies, responsible for regulating clinical studies and auditing of devices.
The MDR entered into force on May 25th 2017 and provides for a staggered transitional period. The new Regulation is due to be fully applicable by May 26th 2020 and introduces wide sweeping and significant new requirements concerning clinical evaluation of devices and post-market obligations. While not mentioned in the Commission’s announcement, a corresponding delay is expected for the In-vitro Diagnostic Devices Regulation (Regulation (EU) 2017/746, the ‘IVDR’), which is due to take effect from May 26th 2022.
Despite the coronavirus crisis, there were already concerns that the MDR would have to be delayed due to the limited number of Notified Bodies that have received accreditation, and the delay in implementation of the European database on medical devices (Eudamed). It is understood that the proposals for delay will be submitted in early April, with the European Parliament and Council urged to adopt the proposal as soon as possible before the deadline for implementation in May 2020.
As final implementation of both the MDR and IVDR will almost definitely now occur after the expiration of the Brexit transition period, the UK government will need to consider whether to adopt identical or divergent regulations in due course.
The Commission’s announcement can be viewed here.