Last update Feb 6, 2020

With the MDR deadline quickly approaching , many medical device manufacturers still don’t know for certain whether their Notified Body will be designated and when!

A handful of large Notified Bodies (NB) have been approved, but for the others we can only guess when (or if) their designation will happen. Frustratingly, there is no published list of Notified Bodies seeking designation, so we created one based on information published online. The organizations on the list below account for more than 80% of all MDD CE certificates. Because there are so many small, local players on the current MDD version section of the NANDO database, we have not included many of them because it is expected that many will not seek designation. Notified Bodies are just beginning to get designated under the IVDR. As Notified Bodies are designated under the MDR or IVDR, we will add them here but you can also confirm this using the NANDO MDR or NANDO IVDR databases. Please help us keep this table up to date. Email us with corrections or additions.


YES TO MDR! – Notified Bodies Designated Under the EU MDR (2017/745)

YES TO IVDR! – Notified Bodies Designated Under the EU IVDR (2017/746)

NO THANKS – Notified Bodies That Have Stated They Will NOT Seek Designation

  • LRQA – 0088
  • QS Zurich – 1254

PENDING – Notified Bodies That Have Confirmed They Are Awaiting Designation to the MDR or IVDR

  • Berlin Cert – 0633 (what they said) – MDR (IVDR unknown)
  • DQS – 0297 (what they said) – MDR (IVDR unknown)
  • ECM/ENTE – 1282 (what they said) – MDR (IVDR unknown)
  • IMNB (Intertek) – 0413 (what they said) – MDR (IVDR unknown)
  • PCBC – 1434 (what they said) – MDR and IVDR
  • QMD Services (what they said) – MDR and IVDR
  • NSAI – 0050 – Direct confirmation from NSAI – MDR (IVDR unknown)
  • SGS Belgium 1639  – (what they said about MDR and IVDR)
  • SGS Fimko 0598 – Direct confirmation from SGS Belgium – MDR (IVDR unknown)
  • SGS UK – 0120 (what they said) – MDR and IVDR
  • TÜV NORD – 0044 (what they said) – MDR (IVDR unknown)


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