On March 7, 2023, the Council of the European Union voted in favour of the new transitional provisions for certain medical devices and in vitro diagnostic medical devices.
The decision passed with the unanimous approval of all 27 Member States.
The new law foresees more time to certify medical devices under the Regulations on Medical Devices (MDR) and In Vitro Diagnostic Medical Devices (IVDR). This decision affects legacy devices, i.e., devices certified under the previous Directives and meeting legacy requirements.
After the Council’s adoption, the European Parliament and the Council will formally adopt the proposed amendment of the Medical Devices Regulation on March 15, 2023. The official publication in the Official Journal and its entering into force will come shortly after.
You can find all Commission and other relevant documents in our Library of Documents.