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Which EU Notified Bodies Have Been “Designated” Under the MDR 2017/745 and IVDR 2017/746?

Shown below is a list of European Notified Bodies that have been designated under the EU MDR or IVDR. As Notified Bodies are officially designated, we will add them here. Help us keep this information up to date. Email us with corrections or additions.

 

EU Notified Bodies designated under the EU MDR (2017/745)

Click the links below or view the entire list on the NANDO MDR database.

 

  1. 3EC International (Slovakia) – 2265 (MDR scope)
  2. Berlin Cert (Germany) – 0633 (MDR scope)
  3. BSI Group (The Netherlands) – 2797 (MDR scope)
  4. Bureau Veritas Italia (Italy) – 1370 (MDR Scope)
  5. CE Certiso Orvos (Hungary) – 2409 (MDR scope)
  6. Cesky Metrologicky Institut (Czechia) – 1383 (MDR scope)
  7. CNCPS (Spain) – 0318 (MDR scope)
  8. CERTIQUALITY (Italy) – 0546 (MDR scope)
  9. DEKRA Certification (Germany) – 0124 (MDR scope)
  10. DEKRA Certification (The Netherlands) – 0344 (MDR scope)
  11. DNV MEDCERT (Germany) – 0482 (MDR scope)
  12. DNV Product Assurance (Norway) – 2460 (MDR scope)
  13. DQS Medizinprodukte (Germany) – 0297– (MDR scope)
  14. ENTE Certificazione Macchine (Italy) – 1282 (MDR scope)
  15. Eurofins Expert Services (Finland) – 0537 (MDR scope)
  16. Eurofins Product Testing (Italy) – 0477 (MDR scope)
  17. GMED (France) – 0459 (MDR scope)
  18. HTCert (Cyprus) – 2803 (MDR scope)
  19. ICIM (Italy) – 0425 (MDR scope)
  20. IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALIT (Italy) – 0051 (MDR scope)
  21. INSTITUTE FOR TESTING AND CERTIFICATION (Czechia) – 1023 (MDR scope)
  22. Intertek (Sweden) – 2862 (MDR scope)
  23. Istituto Superiore di Sanita (Italy) – 0373 (MDR scope)
  24. ITALCERT (Italy) – 0426 (MDR scope)
  25. Kiwa Cermet (Italy) – 0476 (MDR scope)
  26. Kiva Dare (The Netherlands) – 1912 (MDR scope)
  27. MDC Medical Device Certification (Germany) – 0483 (MDR scope)
  28. National Standards Authority of Ireland / NSAI (Ireland) – 0050 (MDR scope)
  29. Notice Belgelendirme, Muayene ve Denetim Hizmetleri Anonim Şirketi (Türkiye) – 2764 – (MDR scope)
  30. POLSKIE CENTRUM BADAN I CERTYFIKACJI (Poland) – 1434 (MDR scope)
  31. SGS Belgium (Belgium) – 1639 (MDR scope)
  32. SGS FIMKO (Finland) – 0598 (MDR scope)
  33. SLG PRUF UND ZERTIFIZIERUNGS (Germany) – 0494 (MDR scope)
  34. Slovenian Institute of Quality and Metrology / SIQ (Slovenia) – 1304 (MDR scope)
  35. SZUTEST (Germany) – 2975 (MDR scope)
  36. TUV NORD CERT (Germany) – 0044 (MDR scope)
  37. TUV NORD Polska (Poland) – 2274 (MDR scope)
  38. TUV Rheinland Italia (Italy) – 1936 (MDR scope)
  39. TUV Rheinland LGA (Germany) – 0197 (MDR scope)
  40. TUV SUD Product Service (Germany) – 0123 (MDR scope)
  41. UDEM Adriatic (Croatia) – 2696 (MDR scope)
  42. UDEM (Türkiye) – 2292 (MDR scope)

 

EU Notified Bodies designated under the EU IVDR (2017/746)

Click the links below or view the entire list on the NANDO IVDR database.

 

  1. 3EC International (Slovakia) – 2265 (IVDR Scope)
  2. BSI (The Netherlands) – 2797 (IVDR scope)
  3. DEKRA Certification (Germany) – 0124 (IVDR scope)
  4. DEKRA Certification (The Netherlands) – 0344 (IVDR scope)
  5. Eurofins (Finland) – 0537 (IVDR scope)
  6. GMED (France) – 0459 (IVDR scope)
  7. MDC MEDICAL DEVICE CERTIFICATION (Germany) – 0483 (IVDR Scope)
  8. National Standards Authority of Ireland / NSAI (Ireland) – 0050 (IVDR scope)
  9. QMD Services GmbH (Austria) – 2962 (IVDR scope)
  10. Sertio (Finland) – 3018 (IVDR scope)
  11. TUV Rheinland LGA (Germany) – 0197 (IVDR scope)
  12. TUV SUD (Germany) – 0123 (IVDR scope)
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