Overview
Regulatory basis - MDR Art. 28–33 / IVDR Art. 25–30. EUDAMED is the European database on medical devices — the central information infrastructure underpinning MDR and IVDR. Manufacturers, EU REPs, importers, and distributors must all register as economic operators.
Economic operator registration (SRN)
Regulatory basis - MDR Art. 30 / IVDR Art. 27. All manufacturers, EU authorised representatives, importers, and (in some cases) distributors must register as economic operators in EUDAMED and receive a Single Registration Number (SRN).
Device registration & UDI upload
Regulatory basis - MDR Art. 28–29 / IVDR Art. 25–26. Manufacturers must register all devices placed on the EU market in EUDAMED, linked to the Basic UDI-DI. Registration is a prerequisite for placing the device on the market within the applicable class timelines.