ARTICLE SUMMARY:
The new guidance addresses structured dialogue and leveraging prior evidence, among other things. Excerpted from Pathways’ Picks February 12: EU Notified Body Guide, FDA Panel Postponed, UK Drops "Cost Saving" Factor, and More.
The European Union provided its first official guidance on what is legally appropriate for notified bodies (NBs) to address in the context of “structured dialogue” interactions with manufacturers in an update published February 7. Structured dialogue has surfaced in recent years as a means for NBs to convey helpful insights related to Medical Device Regulation conformity assessment without running afoul of structure prohibitions against consultancy. In an expanded version of a seminal MDR guidance, “Questions and Answers: Requirements Relating to Notified Bodies,” the EU Medical Device Coordination group added direct discussion of what constitutes prohibited consultancy activities and what is appropriate in a structured dialogue. A new section on structured dialogue features a table that outlines what can be discussed in the pre-application phase and post-application conformity assessment phase. Substantive discussions on things like sufficiency of clinical data, whether a company can claim equivalence to another device, and whether certain exceptions to data-collection requirements might be applicable are only allowed in the post-application period. However, MDCG states, “In general, all structured dialogue should be focused on “what needs to be fulfilled” rather than “how to fulfill.” NBs started offering official structured dialogue programs in 2023, but have repeatedly called for more official guidance to lessen legal ambiguities. (See “Can We Talk? Breaking Down Barriers to Notified Body-Manufacturer Dialogue,”Market Pathways,December 4, 2023.)
The updated notified body guidance also includes another important new section, addressing the concept of “leveraging evidence.” The section states explicitly that in some cases it is appropriate for NBs to rely on previous analysis of evidence rather than expecting a resubmission and review to meet MDR requirements. This gets at one of the core challenges of the EU’s transition to the new regulations: that all existing devices need to be recertified under higher standards to remain on the market. As a result, NBs will often review devices they previously assessed under the legacy EU device directives, but have not been sure if they need to repeat the full analysis. “Notified bodies should avoid unnecessary duplication of work when performing their conformity assessment activities,” the guidance states. They should “make (partial) use of the assessments previously performed on such evidence,” it notes, as long as applicable assessment requirements remain unchanged and other conditions are met. Manufacturers and NBs should discuss when leveraging previous evidence is appropriate during pre-application structured dialogue, MDCG says.