Medical Devices
(BRUSSELS) – The EU Council adopted a regulation Tuesday which extends the deadline for the certification of medical devices, thereby mitigating the risk of shortages for European patients.
The legislative proposal, which follows a positive vote by the European Parliament last month, provides a longer transition period to adapt to new rules foreseen under the Medical Devices Regulation, ensuring continued access to medical devices for patients in need.
Producers of medical devices will now have until 31 December 2027 for higher risk devices and until 31 December 2028 for medium and lower risk devices to meet the legal requirements.
The extension of the transition period will be granted under certain conditions. These ensure that only devices that are safe and for which manufacturers have already started the certification procedure will benefit from the additional time.
The regulation adopted also reduces the risk of medical devices shortages by removing the “sell-off” date rule. The “sell-off” date is the end date after which devices already on the market but not yet with the final user should be withdrawn. Only devices that comply with the previous EU law on medical devices will benefit from this rule. Removing the “sell-off” date will allow safe medical devices to remain longer on the market.
Following today’s adoption by the Council, the proposed amendment to the Medical Devices Regulation is expected to be formally adopted by both the European Parliament and the Council on 15 March. Shortly after, it will be published in the Official Journal and enter into force on the day of its publication.
Commission proposes extension of transitional periods for application of the Medical Devices Regulation - guide
Results of Education, Youth, Culture and Sport Council (Education), 7 March 2023
