ARTICLE SUMMARY:
The European Commission makes good on its promise to give legacy devices a few more years to transition to the MDR. Excerpted from Pathways' Picks January 11: Pathways’ Picks January 11: Codifying CED, Moving MDR Dates, and More from US, Europe, and Asia.
A proposal to give makers of so-called “legacy” devices an extra three-to-four years to transition to the EU Medical Device Regulation came through as promised from the European Commission January 6. As EU Health Commissioner Stella Kyriakides previewed during a December 9 EU Council hearing, the proposal—which still requires approval by the Council and EU Parliament—would allow devices relying on CE marks granted under the pre-May 2021 EU Directives to stay on the market without MDR certificates through 2027 for high-risk devices and through 2028 for medium- and low-risk devices. The previous cut-off was May 2024. Notably, the proposal spells out that the validity of legacy certificates will be extended to match the new transition time and even certificates that expire before the proposed amendments become law will be able to benefit from the extensions as long as the manufacturer has signed a conformity assessment contract with a notified body. For more background and details about the lead-up to the proposal, see: Year-End Flurry Means Big Changes for MDR in 2023: 4 Areas to Watch.
The proposal retains current MDR transition-period conditions, such as a bar on “significant changes” to legacy devices, and adds some new ones. Devices benefiting from the extended transitions, for instance, must not present an “unacceptable risk” to health or safety. But the Commission notes that this does not require any additional oversight beyond standard notified body surveillance. In addition, for a device to qualify, manufacturers must have an MDR-compliant quality management system and have an MDR application submitted to a notified body by May 2024, and have signed an assessment agreement with a notified body by September 2024. There are no allowances for a company to attempt but not be able to secure notified body services due to resource availability.
Fear of major device shortages is what ultimately convinced policymakers to seek the extensions. The proposal would also remove the one-year sell-off deadlines so that unused products that have entered the supply chain don’t need to be disposed of. The sell-off provision is the only one that targets both the MDR and the IVD Regulation (IVDR), which already was amended with transition extensions.
EU lawmakers have generally signaled strong support for the plan and the Commission the proposal will benefit from an “accelerated co-decision procedure” between the Parliament and the Council. In the meantime, the Commission has opened up to the proposal for public comment through March 8.
Trial MyStrategist.com and unlock 7-days of exclusive subscriber-only access to the medical device industry's most trusted strategic publications: MedTech Strategist & Market Pathways. For more information on our demographics and current readership click here.