List of notified bodies updated

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

  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. MDC Medical Device Certification, Germany
  26. DNV Medcert, Germany
  27. National Standards Authority of Ireland (NSAI)
  28. PCBC, Poland
  29. SGS, Belgium
  30. SGS, Finland
  31. SLG, Germany
  32. SIQ, Slovenia
  33. SZUTEST, Germany
  34. TÜV NORD, Poland
  35. TÜV SÜD, Germany
  36. TÜV NORD, Germany
  37. TÜV SÜD, Denmark
  38. TÜV Rheinland, Italy
  39. TÜV Rheinland, Germany
  40. UDEM Adriatic, Croatia
  41. Notice Belgelendirme, Turkey
  42. UDEM, Turkey
  43. Scarlet NB, Netherlands
  44. Cesky Metrologicky Institut, Czech Republic
  45. RISE MNB, Sweden

 

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
  11. Eurofins Electric & Electronics, Finland
  12. Sertio Oy, Finland

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