The notified body list for the Medical Device Regulation (MDR) has been updated, as HTCert, Cyprus, becomes the latest notified body:

The notified body list for the In Vitro Diagnostic Device Regulation (IVDR) remains unchanged:

1. 3EC International, Slovakia
2. BSI, Netherlands
3. Dekra Certification, Netherlands
4. Dekra Certification, Germany
5. QMD Services, Austria
6. GMED, France
7. MDC Medical Device Certification, Germany
8. National Standards Authority of Ireland (NSAI)
9. TÜV SÜD, Germany
10. TÜV Rheinland, Germany

References

Notified Bodies (IVDR), European Commission: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notified-body-list?filter=legislationId:35,bodyTypeId:3,notificationStatusId:1  

Notified Bodies (MDR), European Commission: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notified-body-list?filter=bodyTypeId:3,legislationId: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