References

Notified Bodies (IVDR), European Commission: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=35

Notified Bodies (MDR), European Commission: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34

References

MDD notified bodies: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=13

MDR notified bodies: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34

IVDD notified bodies: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=20

IVDR notified bodies: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=35

Overview of notified body applications, European Commission: https://ec.europa.eu/health/sites/health/files/md_newregulations/docs/notifiedbodies_overview_en.pdf

References

“FDA clarifies types of evidence relevant to determining the intended use of FDA regulated products”, FDA.gov: https://www.fda.gov/news-events/press-announcements/fda-clarifies-types-evidence-relevant-determining-intended-use-fda-regulated-products

“Regulations regarding intended uses”, Federalregister.gov: https://www.federalregister.gov/documents/2020/09/23/2020-20437/regulations-regarding-intended-uses

References

European Commission, “Manual of the working group on cosmetic products (sub-group on borderline products) on the scope of application of the cosmetics regulation (EC) 1223/2009 (Art. 2(1)(A))”: https://ec.europa.eu/docsroom/documents/42850

European Commission, Medical Device Regulation (MDR): https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745

European Commission, Cosmetics Regulation: https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A32009R1223

References

GOV.UK, ” Regulating medical devices in the UK”: https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk

GOV.UK, “UK approved notified bodies”: https://www.gov.uk/government/publications/medical-devices-uk-approved-bodies/uk-approved-bodies-for-medical-devices

GOV.UK, “Register medical devices to place on the market”: https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market#when-register