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

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