TEAM-NB’s interpretation of “Structured Dialogue” between Manufacturer and Notified Body, clarifies little

TEAM-NB has published a new version (v5.0) of its Code of Conduct for Notified Bodies. While we don’t normally comment on this Code, there is one interesting change, namely some guidance on permissible Structured Dialogue between Manufacturers and Notified Bodies.

Historically, Notified Bodies have been prohibited from consulting with medical device Manufacturers in advance of the Conformity Assessment process. This was to avoid any real or perceived conflict of interest. As Notified Bodies act as a quasi-regulator, they should not prejudice that role by providing guidance or assurances to Manufacturers on how to comply with their regulatory obligations. However, this has created an inefficient process whereby Manufacturers do not know about obvious deficiencies in their technical files until they fail the Conformity Assessment. Even then, Manufacturers often have no clarity as to how to resolve any gaps.

The introduction of the EU MDR¹ and IVDR²  dramatically increased the number of medical devices needing to undergo a new Conformity Assessment in the EU. The EU MDR and IVDR also provided relatively little time for these Conformity Assessments to take place, which placed severe strain on Notified Body capacity. These capacity constraints have now largely been resolved as a result of the European Commission introducing legislation to dramatically extend the transition periods for EU MDR and IVDR. However, before this legislation was introduced, the MDCG produced a position paper  proposing various measures intended to alleviate Notified Bodies’ capacity limitations.

One such measure was to encourage Notified Bodies to engage in “Structured Dialogue” with Manufacturers before and during the Conformity Assessment process in order to improve the efficiency and predictability of the process by setting expectations for the Notified Body and the Manufacturer. Such discussions would not be considered impermissible consultation between Notified Body and Manufacturer. However, the MDCG did not explain what “Structured Dialogue” should actually consist of and when it might stray over the line into being impermissible consultation.

TEAM-NB’s Code of Conduct now aims to fill this gap. Page 22 of the Code v5.0 is intended to clarify what Notified Bodies can and cannot discuss with Manufacturers before and during Conformity Assessments:

“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 (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”

While any attempt to expand the scope of permissible interactions with Notified Bodies should be welcomed, this does not move the dial very much. To begin with, this is a short and non-exhaustive list with no interpretive explanation provided for each line item. It is hard to tell what each example actually refers to and how they interact with one another. For instance, it is all well and good that Notified Bodies can discuss “Use of guidance, standards and common specifications” and “Project plans”– but when does this stray into a review of “clinical development strategy”? If these categories are too strictly interpreted, then how useful can Structured Dialogue really be?

In any event, the new TEAM-NB Code of Conduct will be useful for encouraging discussions between medical device Manufacturers and their Notified Bodies.

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[1] Medical Devices Regulation 2017/745
[2] In Vitro Diagnostic Regulation 2017/746
[3] MDCG 2022-14