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.
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).
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.
Regulatory basis - MDR Art. 27(3)–(4) and Art. 28–29 / IVDR Art. 24(3)–(4) and Art. 25–26. Manufacturers must register their devices in EUDAMED using the UDI as the primary identifier before placing devices on the EU market.
Regulatory basis - MDR Art. 92 and Art. 100–105 / IVDR Art. 87 and Art. 97–102. EUDAMED is the central EU information system for medical devices, including the vigilance module for reporting serious incidents and FSCAs.
Both MDR 2017/745 and IVDR 2017/746. UDI requirements are set out primarily in MDR Art. 27 / IVDR Art. 24 and MDR Annex VI / IVDR Annex VI.