The European Council adopted on 7 March 2023 the regulation extending the deadline for the certification of medical devices. The transition period will now close on 31 December 2027 for higher risk devices and on 31 December 2028 for medium and lower risk devices. The new regulation reflects the need to avoid the risk many medical devices would had not be certified in time with the initial cut-off date, and would had thus become unavailable on the European market. The extension of the transition period will be granted only to devices that are safe and for which manufacturers have already started the certification procedure.
The regulation also removed the “sell-off” date rule, thus preventing the risk of medical devices shortages due to the removal from the market of devices that have not already reached their the final users. The entry into force of the new provisions is the publication date of the regulation in the Official Journal of the EU.
The approval by the Council has been welcomed by EU Commissioner for Health and Food Safety, Stella Kyriakides: “I would like to express my gratitude to the European Parliament, the Council, and the Swedish Presidency in particular for swiftly agreeing on our proposal to extend the transitional periods of the Medical Devices Regulation. This is an important step that will help address the short-term difficulties Member States are facing and ensure a continued access to needed medical devices for patients in the EU. This revised timeline will provide more flexibility to industry for the ongoing certification of needed medical devices and reduce short-term risks of shortages. This will ensure access for patients most in need without jeopardising their safety”.
Source: European Council, European Commission