- The European Commission has made Eudamed database modules on UDI/device registration and Certificates and Notified Bodies available for voluntary use.
- Launching the second and third modules continues the roll-out of the database, which was supposed to be ready by the original Medical Device Regulation date of application in 2020 but is now subject to a delayed, staggered launch.
- The Commission has yet to share a timeline for the availability of the rest of the modules, stating only that they will be released when Eudamed is fully functional. European officials have previously targeted a May 2022 launch for the medical device database.
The addition of two new database modules marks a step forward for Eudamed but also continues the long history of delays on the project. Back in July 2020, the Commission was aiming to have the two modules ready by May 2021. That target later slipped to September 2021. Ultimately, the two modules arrived early in October 2021 but without all their features.
MDR envisages Eudamed being used to exchange data related to the Clinical Evaluation Consultation Procedure (CECP), the process through which experts evaluate notified body assessment reports. Yet, the modules have gone live without "the mechanism for scrutiny and the CECP functionalities," the Commission said. The Commission plans to add the features alongside the remaining three modules when Eudamed is fully functional.
Even so, the new modules significantly expand Eudamed. The Commission brought the actor registration module online in December. Now, companies will also be able to use the database to register medical devices and enter their unique device identifiers. The database can also store certificates issued by notified bodies. The use of the modules is currently voluntary.
The update means half of the modules are now available. The three remaining modules cover clinical investigations and performance studies, market surveillance and vigilance. Having previously planned to make the final three modules available as soon as they are functional, the remaining features are now scheduled for launch when Eudamed is fully functional.
In the absence of a fully functional database, the medtech industry has been relying on temporary processes to meet MDR obligations. The Medical Device Coordination Group set out the practices it wants affected organizations to follow for now in guidance that it released and updated ahead of the MDR date of application earlier this year.