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/

References

”Medical devices and Brexit”, Danish Medicines Agency, 05-12-2019. https://laegemiddelstyrelsen.dk/en/licensing/brexit/medical-devices-and-brexit/

“Brexit Transition Period”, Institute for Government (UK), 19-02-2020. https://www.instituteforgovernment.org.uk/explainers/brexit-transition-period

"Getting ready for the end of the transition period", European Commission, 09-07-2020:  https://ec.europa.eu/info/european-union-and-united-kingdom-forging-new-partnership/future-partnership/getting-ready-end-transition-period_en

References

Medical Device Directive (MDD): https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:EN:PDF

Medical Device Regulation (MDR): https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32017R0745&from=EN#d1e32-140-1