The first module of the EU medical device database, EUDAMED, is up and running. However, because actor registration is voluntary until 26 May 2022, when the complete database is planned to be ready, member states can call for actor registration on a national basis under Regulation (EU) 2017/745 on medical devices (MDR).
The launch means that since 1 December, 2020, manufacturers and other economic operators can obtain a Single Registration Number (SRN) and register on a voluntary basis in the database. Distributors are not obliged to register.
It is, however, feared that for increased market surveillance, some countries could demand manufacturers to register themselves locally under the MDR from 26 May 2021 – when the Regulation fully applies – until 26 May 2022 or longer, when EUDAMED becomes fully operational. After that time, information would have to be legally included in the EUDAMED database and made available to all authorities around the EU.
This, of course, is an unwanted scenario, which is why the European Commission has asked EU competent authorities to advertise the process as compliant and try to prevent double registration at a national level. All economic operators are advised to register with EUDAMED promptly to avoid any possible holdups in confirming their EUDAMED registration by their national competent authority. Still, certain member states seem to see potential issues in that regard. Germany, for example, has put the assignment of SRNs on hold for the time being.
The EUDAMED actor registration module went live on 1 December 2020 and is the first of the EUDAMED to be made available. The modules below are yet to be published:
- UDI/Devices registration (is planned to be available from May 2021);
- Notified bodies and certificates;
- Clinical investigations and performance studies;
- Vigilance and post-market surveillance; and
- Marker surveillance
Sources: Medtech Insight (an Informa product), European Commission