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

October 14, 2020
EU MDR & IVDR Updates

UPDATED February 18, 2021

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, as of December 2020 the European Commission has stated that 90% of current MDD NBs and 71% of IVDD NBs are seeking designation. The problem is that although many NB’s are in queue for designation, COVID has stalled progress because on-site audits are required to proceed to the final stage of designation. 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. 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 – 0297  – (MDR scope)
  9. GMED (France) – 0459 (MDR scope)
  10. IMQ (Italy) – 0051 (MDR scope)
  11. Intertek IMNB (Sweden) – 2862 (MDR scope)
  12. Istituto Superiore di Sanita (Italy) – 0373 (MDR scope)
  13. MDC Medical Device Certification (Germany) – 0483 (MDR scope)
  14. MEDCERT (Germany) – 0482 (MDR scope)
  15. NSAI (Ireland) – 0050 – (MDR scope)
  16. SGS FIMKO OY (Finland) – 0598 – (MDR scope)
  17. TÜV Rheinland LGA (Germany) – 0197 (MDR scope)
  18. TÜV SÜD (Germany) – 0123 (MDR scope)
  19. UDEM Adriatic (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. BSI (Netherlands) – 2797 (IVDR scope)
  2. DEKRA Certification – 0124 (IVDR scope)
  3. TÜV Rheinland LGA 0197 (Germany) – (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)
  • 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 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. Also, due to Brexit, some Notified Bodies have shifted from the UK to EU Member States. These include BSI, Intertek and SGS.

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

Our team is here to help. Call 1.800.472.6477 or contact us online ›