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