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

April 1, 2021
EU MDR & IVDR Updates

UPDATED July 27, 2021

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 (Slovakia) – 2265 (MDR scope)
  2. BSI (Netherlands) – 2797 (MDR scope)
  3. CE Certiso (Hungary) – 2409 (MDR scope)
  4. DARE!!! Services (Netherlands) – 1912 (MDR scope)
  5. DEKRA Certification (Germany) – 0124 (MDR scope)
  6. DEKRA Certification (Netherlands) – 0344 (MDR scope)
  7. DNV GL Presafe (Norway) – 2460 (MDR scope)
  8. DQS Medizinprodukte (Germany) – 0297  – (MDR scope)
  9. Eurofins Expert Services (Finland) – 0537 (MDR scope)
  10. Eurofins Product Testing (Italy) – 0477 (MDR scope)
  11. GMED (France) – 0459 (MDR scope)
  12. IMQ (Italy) – 0051 (MDR scope)
  13. Intertek IMNB (Sweden) – 2862 (MDR scope)
  14. Istituto Superiore di Sanita (Italy) – 0373 (MDR scope)
  15. MDC Medical Device Certification (Germany) – 0483 (MDR scope)
  16. MEDCERT (Germany) – 0482 (MDR scope)
  17. NSAI (Ireland) – 0050 – (MDR scope)
  18. SGS FIMKO (Finland) – 0598 – (MDR scope)
  19. TÜV Rheinland LGA (Germany) – 0197 (MDR scope)
  20. TÜV SÜD (Germany) – 0123 (MDR scope)
  21. UDEM Adriatic (Croatia) – 2696 (MDR scope)
  22. Kiwa Cermet Italia S.P.A. (Italy) – 0476 (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. BSI (Netherlands) – 2797 (IVDR scope)
  2. DEKRA Certification (Germany) – 0124 (IVDR scope)
  3. DEKRA Certification (Netherlands) – 0344 (IVDR scope)
  4. TÜV Rheinland LGA (Germany) 0197 – (IVDR scope)
  5. 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.

  • Berlin Cert – 0633 (what they said) – MDR (IVDR unknown)
  • DNV GL Presafe – 2460 (what they said) – IVDR (already have MDR designation)
  • ECM Italy – 1282 (what they said) – MDR only
  • PCBC – 1434 (what they said) – MDR and IVDR
  • QMD Services (what they said) – MDR and IVDR
  • SGS Belgium 1639  – (what they said about MDR and IVDR)
  • TÜV NORD – 0044 (what they said) – MDR (IVDR unknown)
  • TÜV NORD Polska – 2274 – Direct confirmation from Head of Certification (MDR)

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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