15.11.2021
To the attention of Romanian manufacturers of medical devices
UDI/Device registration – in EUDAMED
The new EU regulations of MDR 2017/745 and IVDR 2017/746 introduce a medical device identification system based on a unique device identifier (UDI), which allows easier traceability. These regulations require medical device manufacturers to submit UDI/Device information for all medical devices they place on the market. The UDI-DI/Device module of EUDAMED is used for this purpose.
From October 2021, EUDAMED’s UDI-DI/Device module is available and manufacturers can already enter the UDI/Device information into the system voluntarily.
For more information, we recommend that you access the European Commission website: https://ec.europa.eu/health/md_eudamed/udi_devices_registration_ro
The guideline providing all the information required in order to register UDI/Devices into the Eudamed can be accessed here: https://ec.europa.eu/health/sites/default/files/md_eudamed/docs/md_eudamed_udi-devices-user-guide_en.pdf