Page Last Updated: 7 September 2023
EUDAMED is the European Database on Medical Devices. It is similar to other public government databases, such as the US FDA’s database, which contains all registered Establishments, 510(k)s and pre-market approvals, device listings, adverse events/recalls, clinical investigation data, and more.
EUDAMED is referenced throughout the Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR). EUDAMED is designed to house information such as:
- registration of economic operators (specifically: manufacturers, authorized representatives, importers);
- registration of devices;
- CE marking certificates;
- clinical investigations;
- vigilance and market surveillance.
The information is public and it is obligatory that all responsible parties comply and populate the database with the appropriate information.
Registration in EUDAMED is separate from marketing approval/conformity assessment. Companies must first obtain marketing authorization for the device, i.e., CE Marking. Then they can register that device into EUDAMED.
EUDAMED aims to consolidate medical device and IVD registration information into a central databank. It can seem complicated, when in fact the steps for EUDAMED compliance are straight-forward.