Eudamed – requirements for all medical device manufacturers

01_Eudamed blog-indlg opdateret 05-03-2021PNG

02_Eudamed blog-indlg opdateret 05-03-2021PNG


European Commission, Eudamed (direct access to registration):

European Commission, Eudamed database (search for registered manufacturers, importers and authorized representatives):

European Commission, Eudamed: Overview:

Medical Device Regulation (EU) 2017/745, article 33:

European Commission, “Management of Legacy Devices – MDR Eudamed”:

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”:

Medical Device Coordination Group, “MDCG 2021-1 - Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional”:

CEPK, "Eudamed and UDI facts from the European Commission":