The notified body list for the In Vitro Diagnostic Device Regulation (IVDR) has been updated, as Istituto Superiore Di Sanita, Italy, becomes the latest notified body:

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
11. Eurofins Electric & Electronics, Finland
12. Sertio Oy, Finland
13. Istituto Superiore Di Sanita, Italy
    
    

1. 3EC International, Slovakia
2. AEMPS, Spain
3. BSI, Netherlands
4. Bureau Veritas, Italy
5. Berlin Cert, Germany
6. CE Certiso Orvos, Hungary
7. Certiquality, Italy
8. Dekra Certification, Netherlands
9. Dekra Certification, Germany
10. DNV Product Assurance, Norway
11. DQS Medizinprodukte, Germany
12. ECM, Italy
13. Eurofins Electric & Electronics, Finland
14. Eurofins Product Testing, Italy
15. GMED, France
16. HTCert, Cyprus
17. ICIM, Italy
18. IMQ, Italy
19. Institute for Testing and Certification, Czech Republic
20. Istituto Superiore Di Sanita, Italy
21. Italcert, Italy
22. Intertek, Sweden
23. Kiwa Cermet, Italy
24. Kiwa Dare, Netherlands
25. Kiwa Belgelendirme, Turkey
26. MDC Medical Device Certification, Germany
27. DNV Medcert, Germany
28. National Standards Authority of Ireland (NSAI)
29. PCBC, Poland
30. SGS, Belgium
31. SGS, Finland
32. SLG, Germany
33. SIQ, Slovenia
34. SZUTEST, Germany
35. TÜV NORD, Poland
36. TÜV SÜD, Germany
37. TÜV NORD, Germany
38. TÜV SÜD, Denmark
39. TÜV Rheinland, Italy
40. TÜV Rheinland, Germany
41. AFNOR Certification, France
42. UDEM Adriatic, Croatia
43. Notice Belgelendirme, Turkey
44. UDEM, Turkey
45. Scarlet NB, Netherlands
46. Cesky Metrologicky Institut, Czech Republic
47. RISE MNB, Sweden
48. QMD Services, Austria
49. MTIC InterCert, Italy

References

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

Notified Bodies (MDR), European Commission: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notified-body-list?filter=legislationId:34,notificationStatusId:1

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