5th revision of the MDCG 2019-6: Q&A on the requirements relating to NBs 

The Medical Device Coordination Group (MDCG) has published an update to its Q&A related to notified bodies’ requirements under MDR and IVDR.

The main changes are:

• Details on the structured dialogue (see section I.6);
• Clarification on the surveillance audits frequency (see section IV.10);
• Precisions on certification renewal (see section IV.12);
• Introduction of the “leveraging evidence” in section IV.13 and in the rest of the document.

DOWNLOAD THE MDCG 2019-6 Rev.5