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?
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!