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

Office of information and regulatory affairs, “Harmonizing and modernizing regulation of medical device quality systems”: https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202004&RIN=0910-AH99

FDA, “Transition to ISO 13485:2016”: https://www.fda.gov/media/123488/download

FDA, Quality System Regulation, Code of Federal Regulations Title 21, Part 820: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820

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

European Committee for Standardization (CEN), “In the fight against Covid-19, CEN made new European standards for ventilators freely available”: https://www.cen.eu/news/brief-news/Pages/NEWS-2020-004.aspx

References

European Commission, “How to verify that medical devices and personal protective equipment can be lawfully placed on the EU market and thus purchased and use”: https://ec.europa.eu/docsroom/documents/41385