• Armağan

European database on medical devices (EUDAMED)

The new regulations on medical devices (MDR) and on in vitro diagnostic medical devices (IVDR) establish a much wider EUDAMED database than the existing one under the current directives (Eudamed2).

Currently, the EC database on medical devices, Eudamed2, is a secure web-based portal. It is a central repository for information on market surveillance exchanged between national competent authorities and the Commission. Its use is restricted to national competent authorities, it is not open for consultation and is not publicly accessible.

However, the new medical devices regulations contain important improvements including a much larger EUDAMED database. The new rules will only apply after a transitional period 

3 years after entry into force for the regulation on medical devices (spring 2020) 5 years after entry into force for the regulation on in vitro diagnostic medical devices (spring 2022)

We expect the new EUDAMED database to be in production and available to the public in 2020. It will contain different modules on actors, UDI & devices, notified bodies & certificates, vigilance, clinical investigations & performance studies and market surveillance. It will be multipurpose. It functions as a registration system, a collaborative system, a notification system, a dissemination system (open to the public), and will be interoperable.

The official web address of the EUDAMED public site will be: https://ec.europa.eu/tools/eudamed

For details: