MDCG 2019-6, ‘Questions and answers: Requirements relating to notified bodies’, updated

MDCG 2019-6 has been revised and reissued as Rev.5, with changes related to ‘structured dialogue’ and ‘leveraging evidence’ being included.

The main change has been to add section IV.13, ‘What is considered “Leveraging evidence”?’, which explains that: “notified bodies should avoid unnecessary duplication of work when performing their conformity assessment activities. In this respect, a differentiation between evidence provided by the manufacturer and assessment of such evidence already performed by notified bodies needs to be made.”

The guidance continues:

“As part of the structured dialogue (see Q&A I.6.3), for (a) specific device(s), manufacturers and notified bodies should discuss and agree in the pre-application phase if / which evidence provided with previous applications by the manufacturer can be referred to. In principle, this is possible as long as the evidence provided still meets the “state of the art”.”

In addition, in new sub-section I.6.3, ‘What is “structured dialogue”?’, the guidance now advises that: “during a structured dialogue in the post-application phase, manufacturer and notified body may exchange views on the sufficiency of clinical data on which the clinical evaluation is based, including possible applicability of Article 61(10) of MDR, equivalence of the device under assessment with another device as well as the appropriateness of the post-market clinical follow-up plan. Such kind of structured dialogue in the early phase after submission of the application can significantly increase the predictability of the conformity assessment process without jeopardising the notified body’s independence or impartiality.”

This is a very welcome change from previous guidance that implied that discussion of clinical strategy was not an appropriate subject for structure dialogue.