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Blog UDI facts 02-02-2021PNG

References

“Unique Device Identification (UDI) System – FAQs”, European Commission: https://ec.europa.eu/docsroom/documents/42641?locale=en

“Eudamed – requirements for all medical device manufacturers”, CEPK: https://cepk.dk/blog/eudamed-requirements-for-all-medical-device-manufacturers

Medical Device Regulation (EU) 2017/745, Official Journal of the European Union: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745

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

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

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

European Commission, “Management of Legacy Devices – MDR Eudamed”: https://ec.europa.eu/health/sites/health/files/md_eudamed/docs/legacy_dvc_management_en.pdf

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

Medical Device Coordination Group, “MDCG 2021-1 - Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional”: https://ec.europa.eu/health/sites/health/files/md_sector/docs/2021-1_guidance-administrative-practices_en.pdf

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

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