May 07, 2022

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

EU MDR & IVDR Updates

UPDATED October 21, 2022

Shown below is a list of European Notified Bodies that have been designated under the EU MDR or IVDR. There is no current list of Notified Bodies seeking designation but some have indicated their intent on their website and we have added them in the pending list below. 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.

YES! 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 a.s. (Slovakia) – 2265 (MDR scope)
  2. Berlin Cert Prüf- und Zertifizierstelle für Medizinprodukte GmbH (Germany) – 0633 (MDR scope)
  3. BSI Group The Netherlands B.V. (Netherlands) – 2797 (MDR scope)
  4. BUREAU VERITAS ITALIA S.P.A. (Italy) – 1370 (MDR Scope)
  5. CE Certiso és Kórháztechnikai Ellenőrző és Tanúsító Kft. (Hungary) – 2409 (MDR scope)
  6. CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS / AEMPS (Spain) – 0318 (MDR scope)
  7. CERTIQUALITY S.r.l. (Italy) – 0546 (MDR scope)
  8. DEKRA Certification GmbH (Germany) – 0124 (MDR scope)
  9. DEKRA Certification B.V. (Netherlands) – 0344 (MDR scope)
  10. DNV Product Assurance AS (Norway) – 2460 (MDR scope)
  11. DQS Medizinprodukte GmbH (Germany) – 0297  – (MDR scope)
  12. ENTE CERTIFICAZIONE MACCHINE SRL (Italy) – 1282 (MDR scope)
  13. Eurofins Expert Services Oy (Finland) – 0537 (MDR scope)
  14. Eurofins Product Testing S.r.l. (Italy) – 0477 (MDR scope)
  15. GMED SAS (France) – 0459 (MDR scope)
  16. IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A. (Italy) – 0051 (MDR scope)
  17. Intertek Medical Notified Body AB (Sweden) – 2862 (MDR scope)
  18. Istituto Superiore di Sanita (Italy) – 0373 (MDR scope)
  19. ITALCERT SRL (Italy) – 0426 (MDR scope)
  20. Kiwa Cermet Italia S.P.A. (Italy) – 0476 (MDR scope)
  21. Kiva Dare B.V. (Netherlands) – 1912 (MDR scope)
  22. MDC Medical Device Certification GmbH (Germany) – 0483 (MDR scope)
  23. MEDCERT Zertifizierungs-und Prüfungsgesellschaft für die Medizin GmbH (Germany) – 0482 (MDR scope)
  24. National Standards Authority of Ireland / NSAI (Ireland) – 0050 (MDR scope)
  25. POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. (Poland) – 1434 (MDR scope)
  26. SGS Belgium NV (Belgium) – 1639 (MDR scope)
  27. SGS FIMKO OY (Finland) – 0598 (ex-0403) – (MDR scope)
  28. Slovenian Institute of Quality and Metrology / SIQ (Slovenia) – 1304 (MDR scope)
  29. TÜV NORD CERT GmbH (Germany) – 0044 (MDR scope)
  30. TÜV NORD Polska Sp. z o.o (Poland) – 2274 (MDR scope)
  31. TÜV Rheinland Italia SRL (Italy) – 1936 (MDR scope)
  32. TÜV Rheinland LGA Products GmbH (Germany) – 0197 (MDR scope)
  33. TÜV SÜD Product Service GmbH (Germany) – 0123 (MDR scope)
  34. UDEM Adriatic d.o.o. (Croatia) – 2696 (MDR scope)

YES! 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 (Netherlands) – 2797 (IVDR scope)
  3. DEKRA Certification (Germany) – 0124 (IVDR scope)
  4. DEKRA Certification (Netherlands) – 0344 (IVDR scope)
  5. GMED SAS (France) – 0459 (IVDR scope)
  6. TÜV Rheinland LGA (Germany) 0197 – (IVDR scope)
  7. TÜV SÜD (Germany) – 0123 (IVDR scope)

PENDING – Notified Bodies awaiting designation to the MDR or IVDR

Because there are many small regional Notified Bodies with relatively few medical device clients, we have not included most of them below. If your Notified Body is seeking designation but is not listed, email us.

NO! EU Notified Bodies that have chosen NOT to seek designation

These Notified Bodies have publicly stated that will not seek designation to the MDR or IVDR.

  • DNV GL – 0434
  • DQS Polska – 2282
  • ECM Germany – 0481
  • LRQA – 0088
  • QS Zurich – 1254
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