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
“Commission guidance for the medical devices expert panels on the consistent interpretation of the decision criteria in the clinical evaluation consultation procedure”, Official Journal of the European Union: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=OJ:C:2020:259:FULL&from=EN
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
Medical Device Regulation (EU) 2017/745, Official Journal of the European Union: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745
In Vitro Diagnostics Regulation (IVDR): https://eur-lex.europa.eu/eli/reg/2017/746/oj
MDCG 2019-16, ”Guidance on Cybersecurity for medical devices”: https://ec.europa.eu/docsroom/documents/41863
References
Medical Device Regulation (EU) 2017/745, Official Journal of the European Union: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745
Annual Report 2019, European Medicines Agency: https://www.ema.europa.eu/en/annual-report-2019/new-eu-legislation-applicable-ema.html
References
Medical Device Regulation (EU) 2017/745, Official Journal of the European Union: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745
Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices, Official Journal of the European Union: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2020.130.01.0018.01.ENG&toc=OJ:L:2020:130:TOC
MDCG guidance documentation overview, European Commission: https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en
Ongoing Guidance development within MDCG Subgroups, European Commission: https://ec.europa.eu/docsroom/documents/38862