EUDAMED DELAYED UNTIL MAY 2022

The European Commission has confirmed these days that EUDAMED will not start in May 2020, but will be operational from May 2022.

Since EUDAMED will contain different modules on actors, notified bodies, UDI, surveillance, clinical trials and market surveillance, the Commission concluded that the database will be operational only when the entire system and therefore all its different modules will be fully functional and will have been subjected to an independent audit. For this reason, the launch of the EUDAMED database has been postponed and will be done together for medical and in vitro medical devices, at the original date foreseen for in vitro medical devices, i.e. May 2022.

The date of application of the MDR remains May 2020.

https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/eudamed_it