MDCG Q&A for Notified Bodies

The MDCG has just published useful Questions & Answers document, especially relevant for the Notified Bodies. It focuses on the Notified Bodies’ requirements under MDR and IVDR, and addresses questions as:

  • Are CABs obliged to follow guidance endorsed by the Medical Devices Coordination Group (MDCG)?
  • Is a 3-year competitor clause for consultants covered in the MDR / IVDR requirements?
  • May CAB provide pre-certification services?

Check the full Q&A here!

The Q&A will be updated by the MDCG when new issues arise.

Follow our Library of documents, all MDR&IVDR related documents, including those endorsed by the MDCG for all updates!

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