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
Medical Device Coordanation Group, MDCG 2020-12: “Guidance on transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product and which has action ancillary to that of the device, as well as on devices manufactured using TSE susceptible animal tissues”: https://ec.europa.eu/docsroom/documents/41622
References
European Medicines Agency, “First Covid-19 treatment recommended for EU authorization: https://www.ema.europa.eu/en/news/first-covid-19-treatment-recommended-eu-authorisation
9 June 2020
References
European Medicines
Agency, “EMA receives application for conditional authorisation of first
COVID-19 treatment in the EU”: https://www.ema.europa.eu/en/news/ema-receives-application-conditional-authorisation-first-covid-19-treatment-eu
US Food and Drug Administration,
“FDA Issues Emergency Use Authorization for Potential COVID-19 Treatment”: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-emergency-use-authorization-potential-covid-19-treatment