What is Structured Dialogue?
Clearer conversations. Greater predictability.
A Structured Dialogue is a recognized meeting between a manufacturer and its Notified Body. The Medical Device Coordination Group (MDCG) encourages these dialogues before and during conformity assessment. It gives medical device and IVD manufacturers direct access to our technical, clinical and regulatory experts, so you understand how we assess conformity before you submit, not after.
How a Structured Dialogue supports your certification journey
- Efficiency. You clarify submission requirements and application documentation expectations before you submit.
- Predictability. You discuss realistic timescales, so your regulatory milestones stay aligned with your launch planning.
- Expertise. You hear directly from our technical, clinical and regulatory team on how we interpret a regulation requirement, a standard or a guidance document.
Our approach to Structured Dialogue is simple. A dedicated meeting, focused on procedural aspects, submission processes and conformity assessment challenges.
Its purpose is for you to prepare questions that matter to you most, without compromising our independence or impartiality as a Notified Body; and allowing you to move forward with clarity and confidence.
"The 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."
MDCG 2022-14 Position Paper, Medical Device Coordination Group, August 2022
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Start with an event and meet our knowledgeable team to help you take the first step on your certification journey.
