Blog/Category

EUDAMED

EUDAMED is the European database for medical devices, established under Articles 33-43 of the Medical Device Regulation (EU) 2017/745. From 28 May 2026, registration in the Actor, UDI/Devices and Notified-Body modules is mandatory for any economic operator placing devices on the EU market. Posts in this category cover the operational specifics: how to submit an actor request, what the competent authority checks before issuing an SRN, the structural hierarchy of Basic UDI-DI and UDI-DI records, bulk upload XML, and the most common rejection causes.