List of notified bodies updated

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

The notified body list for the Medical Device Regulation (MDR) remains unchanged:

  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