What can manufacturers expect through ‘structured dialogue’?

Perhaps the answer lies in the latest edition of TEAM-NB’s Code of Conduct which devotes a section to ‘structured dialogue’ for the first time, following the MDCG’s inclusion of the term in guidance documents MDCG 2022-14 and MDCG 2022-11 Rev. 1. As a reminder:

MDCG 2022-11 Rev.1 states:

“A proper assistance to manufacturers with regulatory guidance and technical information on how to apply for the conformity assessment procedure10 is key for a smoother and faster process and to avoid incomplete applications, which have been identified as an important cause of the delays. Such assistance is particularly relevant for SMEs. The MDCG reminds notified bodies to organise structured dialogues with manufacturers [ref 11], which is expected to be part of the normal pre-application and conformity assessment activities and therefore not to be a separated service to be charged for.”

Ref 11 refers to MDCG 2022-14 action 15, which explains that:

“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. Such dialogues should not be considered consultancy service.”

The TEAM-NB Code of Conduct now includes the following explanation on the subject:

“MDCG 2022 14 published in August 2022 encouraged NBs to organise structured dialogue with manufacturers before and during conformity assessment. The aim was to enhance the efficiency and predictability of conformity assessment, while not consulting.

NBs can discuss (non-exhaustive examples):
− Project plans
− Submission requirements
− Requirements for reporting change
− Use of guidance, standards and common specifications
− Costs and timelines

NBs cannot [discuss] (non-exhaustive examples):
− Complete gap analyses
− Check for MDR/IVDR readiness
− Review mock files for MDR/IVDR conformity
− Review clinical development strategy
− Provide technical solutions
− Explain how the manufacturer should meet specific regulatory requirements

There may not be a need for Structured Dialogue if information is provided in Best Practice Guidance Documents.”

Unfortunately, discussion of a clinical development strategy would probably be the most useful activity a Notified Body could undertake in the early stages of conformity assessment, potentially saving manufacturers significant time and cost if, at the time of technical documentation review, the Notified Body disagreed with the adopted strategy, so many will feel that this is a transparency opportunity wasted.