The MDCG has updated the useful Questions & Answers document focusing on the Notified Bodies' requirements under MDR and IVDR. It widens the scope of the original version, released earlier in June 2019, and addresses new questions in Sections III and IV as:
- What is the meaning of “possess or have access to all equipment and facilities” needed to perform its tasks within the meaning of Section 3.1.1 of Annex VII of the MDR?
- What is the meaning of "two years' professional experience" in . . .
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