Eudamed – requirements for all medical device manufacturers

Blog Eudamed opdateret 01-12-2020PNG

References

European Commission, Eudamed (direct access to registration): https://webgate.ec.europa.eu/eudamed/landing-page#/

European Commission, Eudamed database (search for registered manufacturers, importers and authorized representatives): https://ec.europa.eu/tools/eudamed/#/screen/home

European Commission, Eudamed: Overview: https://ec.europa.eu/health/md_eudamed/overview_en

Medical Device Regulation (EU) 2017/745, article 33: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745#d1e3382-1-1

Medical Device Coordination Group, “MDCG 2020-15 - MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States”: https://ec.europa.eu/health/sites/health/files/md_sector/docs/2020-15-position-paper-actor-registration-module_en.pdf

CEPK, "Eudamed and UDI facts from the European Commission": https://cepk.dk/blog/eudamed-and-udi-facts-from-the-european-commission