In partnership with MDR Consultants, here are a few pointers on how to find the registration date for your products.
In accordance with the provisions of Article 120 of the EU MDR (2017/745), on May 26th of 2021 all manufacturers of legacy devices shall have had a quality management system and related outputs, as applicable, conformant to the following requirements of the regulation:
However, it fails to mention the requirements related to the UDI which are needed in order for a manufacturer to be able to register their devices into EUDAMED. Because of this inconsistency in the provisions of the regulation, the European Commission released two guidance documents to guide us through this issue. These two guidance documents include MDCG 2019-4 (Timelines for registration of device elements into EUDAMED) and MDCG 2019-5 (Registration of legacy devices in EUDAMED, class 1 footnote).
Registration of legacy devices would be due 18 months (about 1 and a half years) from the date of application of the EU MDR (2017/745) IF EUDAMED was fully functional. Class 1 devices that do not have a CE certificate and are self-declared should be registered as EU MDR devices by the date of the application. However, if EUDAMED is NOT fully functional, all registration is due 24 months (about 2 years) after the notification that EUDAMED is fully functional by this being published in the Official Journal of EU.
The deadline to transition to the EU MDR is May 26, 2024. Are you looking for information on how to start the transition or how to best structure your organization?