Structured Dialogue for (IVD) Medical Devices in Europe: Now Will Finally Get Some Answers

Description: The session will be a panel discussion from different stakeholders on "structured dialogue" as is presented in MDCG 2022-14 document. The MDCG encourages notified bodies and manufacturers to organise structured dialogues before and during the conformity assessment process aimed at regulatory procedures where this is useful to enhance the efficiency and predictability of the conformity assessment process, while respecting the independence and impartiality of the notified body. Nevertheless, this should not be conceived as "consultancy" or scientific advise. A structured dialogue between applicant and NBs should be voluntary. It should help the applicant to submit a compliant application in the first place (the aims being to save time during conformity assessment and prevent rework on the part of the manufacturer), ultimately avoiding additional loops, delay and workload within medical device and IVD conformity assessment procedures and to achieve regulatory compliance in a timely, efficient and predictable manner.

At the moment of writing, some notified bodies have taken the initiative to offer structured dialogues with device manufacturers. The panel discussions focuses on the process of structured dialogue; what should and what should it not cover in practice. In addition, (good and bad) experiences with structured dialogue will be shared with the audience. If possible, the discussions could result in positions for industry, notified bodies and regulators on the effectiveness of the structured dialogue process.