On 6 January 2023, the European Commission submitted a proposal to extend the transitional period for the recertification of medical devices referred to as legacy devices under Regulation 2017/745 (MDR). These devices were placed on the market on the basis of certificates issued under Council Directives 90/385/EEC and 93/42/EEC.
Last week, this proposal was adopted by the European Parliament and the Council of the EU. It is now awaiting approval by Member States.
However, only manufacturers who have already started to prepare for the new rules can take advantage of the newly extended transition period. The manufacturer must implement a new quality management system in accordance with the regulation by 26 May 2024 at the latest, and he or his authorized representative must submit a formal application for certification of the device to a notified body by the same date and sign a written certification agreement with the notified body by 26 September 2024 at the latest. Such a device must continue to meet the requirements under the existing rules. The provision with a one-year deadline (i.e. until 26.5.2025) for the resale of medical devices is also repealed.
More information can be found here: EUR-Lex - ST_6292_2023_INIT - EN - EUR-Lex (europa.eu)
