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
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
References
Medical Device Regulation, article 29, 30, 31, 87, 120: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32017R0745&from=EN
“New enhanced reporting requirement is to strengthen the surveillance of medical devices”, Danish Medicines Agency: https://laegemiddelstyrelsen.dk/en/news/2020/new-enhanced-reporting-requirement-is-to-strengthen-the-surveillance-of-medical-devices/