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

October 14, 2020
EU MDR & IVDR Updates

UPDATED October 23, 2020

With the MDR deadline approaching, many medical device manufacturers do not know for certain whether their Notified Body (NB) will be designated and when! There is no current list of Notified Bodies seeking designation. However, the European Commission has stated that 44 MDR and 11 IVDR applications have been received. That represents a surprising 86% of current MDD NBs and 50% of IVDD NBs.

The organizations on the list below account for more than 80% of all MDD/IVDD CE certificates. As Notified Bodies are designated under the MDR or IVDR, we will add them here. Help us keep this table 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. BSI (UK) – 0086 (MDR scope)
  4. CE Certiso (Hungary) – 2409 (MDR scope)
  5. DARE!!! Services (Netherlands) – 1912 (MDR scope)
  6. DEKRA Certification (Germany) – 0124 (MDR scope)
  7. DEKRA Certification (Netherlands) – 0344 (MDR scope)
  8. DNV GL Presafe (Norway) – 2460 (MDR scope)
  9. DQS Medizinprodukte – 0297  – (MDR scope)
  10. GMED (France) – 0459 (MDR scope)
  11. IMQ (Italy) – 0051 (MDR scope)
  12. Intertek IMNB (Sweden) – 2862 (MDR scope)
  13. MDC Medical Device Certification (Germany) – 0483 (MDR scope)
  14. MEDCERT (Germany) – 0482 (MDR scope)
  15. NSAI (Ireland) – 0050 – (MDR scope)
  16. TÜV Rheinland LGA (Germany) – 0197 (MDR scope)
  17. TÜV SÜD (Germany) – 0123 (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. BSI (UK) – 0086 (IVDR scope)
  3. DEKRA Certification – 0124 (IVDR scope)
  4. 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)
  • 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)
  • SGS Fimko 0598 – Direct confirmation from SGS – MDR (IVDR unknown)
  • SGS UK – 0120 (what they said) – 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 are NOT seeking designation

We know this list is underrepresented. These Notified Bodies have publicly stated that they will not seek designation to the MDR or IVDR. See this NANDO list.

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

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