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Repeat Solutions Circle
Evaluation ViewAttendees 31

Devices (includes Medical Devices & In Vitro Diagnostics)

Structured Dialogues: 10 Effective Topics to Engage With Your Notified Body

Thursday, October 9, 2025
1:00 PM - 2:00 PM EST
Location/Room: 406
To overcome the hurdle of not being able to anticipate some of the processes and views your notified body might have in their assessment of your CE dossier submission, Europe came up with the structured dialogues. Structure dialogues serve as a means to facilitate the discussions between notified bodies and their clients that were historically not permitted under the MDR as notified bodies are not allowed to 'consult' their clients. That means that there are some opportunities to engage, but the border of not consulting remains in place. This panel will present and discuss approaches to the structured dialogue, featuring 10 key topics you may fruitfully include in the agenda of your structured dialogue. The panel will feature speakers from 3 notified bodies.

Session Agenda:
  • Brief intro from moderators on topic (Gert) and speakers (Sabina)

  • Each panellist 5-6 minutes on critical points observed and something like a case or an example

    • Richard

    • Matthias

    • Bianca

    • Leo

  • One round of reflection on points from other panellists

  • Q&A with audience

  • Final round of 30 sec per speaker, in reverse order as above

  • Wrap up: Sabina and Gert

Learning Objectives:

  • You will have a better understanding of go's and no-go's for topics in structured dialogue with your Notified Body
  • You will have a better feel for how to approach a discussion in structured dialogue
  • you will be able to strategize your structured dialogue meeting to get the most out of it