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 cases where the experience has been gained within a CAB under Section 3.2.5 of Annex VII?
- What is the meaning of “permanent availability of personnel with relevant clinical expertise” in accordance with Sections 3.2.4 and 1.1 of Annex VII?
- What is the meaning of allocation of resources under Section 4.4 of Annex VII?
- What is the frequency of surveillance audits according to the Regulations?
- What are the applicable requirements for re-certification?
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