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

European Commission, “Availability and capacity of notified bodies to carry out conformity assessments for Covid-19 related medical devices and in vitro diagnostic medical devices”: https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_survey-conformity-assess-covid-19.pdf

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