Eudamed to Launch in 2022 for Both Devices and IVDs

Regulatory NewsRegulatory News | 30 October 2019 |  By 

The European Commission recently concluded that its database of medical device information (Eudamed) will only be operational once all modules are fully functional and an independent audit has been conducted, so the commission has decided to launch the database simultaneously for both medical devices and in-vitro diagnostics together in May 2022.

The two-year delay of the database for medical devices (the commission reiterated that date of application of the Medical Devices Regulation (MDR) remains May 2020) effectively means that device manufacturers can postpone their entering of data into Eudamed. According to the consultancy Emergo, during an 18-month period after the application of Eudamed, all data related to the devices that manufacturers are placing on the EU market must be entered. 

Unlike the current Eudamed2 database, which acts as a central repository for information on market surveillance exchanged between national competent authorities and the commission, the new database will contain different modules on actors, unique device identifiers (UDIs), notified bodies and certificates, vigilance, clinical investigations and performance studies and market surveillance.

The commission has previously issued guidance on what UDI data need to be included in Eudamed, a device data dictionary, how legacy devices can be registered in Eudamed without a UDI and how device companies will have to register device data elements into Eudamed. The commission has also released guidance on Eudamed data exchange services.

The Eudamed functional specifications (v4.1) also have been public since 7 February.

European database on medical devices (EUDAMED)


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy