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The notified body list for the Medical Device Regulation (MDR) has been updated, as HTCert, Cyprus, 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. EMC, Italy
  13. Eurofins Expert Services, 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. 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 Rheinland, Italy
  38. TÜV Rheinland, Germany
  39. UDEM Adriatic, Croatia

 

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


Blog Borderline Cosmetic devices 28-01-2021PNG

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

Blog UK new regulations 28-01-2021PNG

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


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