ARTICLE SUMMARY:
In this week’s Pathways Picks: The EU updates its notified body guidance to address structured dialogue and leverage prior evidence, formalizes its “scientific advance” program, and pilots multinational study assessments; FDA postpones the only device panel on its calendar, reposts some documents, and faces more pressures to cull workforce; the UK tech assessor NICE proposes removing “cost saving” as a condition for device adoption; and updates from South Korea and Saudi Arabia.
EU Picks
Structured dialogue, levering evidence, clinical pilots, and more:
First guidance on structured dialogue... The EU 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.)
