Introduction

Since the MDR and IVDR came into force, manufacturers have often described their interactions with Notified Bodies (NBs) as opaque, unpredictable, or even frustrating. What if you could talk to your NB earlier, with clearer expectations on both sides—without crossing the line into consulting?

That’s precisely what the latest MDCG 2019-6 Rev. 5 guidance introduces: the structured dialogue, a pragmatic communication tool that helps manufacturers and NBs engage more efficiently and transparently.

 

What is the structured dialogue?

Structured dialogue is not a shortcut or a backdoor to approval. It’s a formalized interaction framework designed to clarify what must be done, not how to do it.

According to section I.6.3 of MDCG 2019-6 Rev.5 (2025), structured dialogue is:

• – Structured: Defined topics, traceable format, documented exchanges.

• – Mutual: Initiated by either party.

• – Bounded: Focused on clarification, not advice.

• – Free: Included into the fees of the conformity assessement procedures.

🔒 NBs are not allowed to conduct activities that are part of or could fall under the definition of conformity assessment activities (e.g., review of clinical data or QMS) and provide the expected solutions (i.e., deliver consulting services)

Structured dialogue is not needed for every submission. However, it is highly valuable when:

• – You have complex clinical data or are building a strategy from multiple evidence types (e.g. literature, real-world data)

• – You are submitting a first-in-class or high-risk device

• – You’re unsure about the depth of post-market data required

• – You have questions about study design, sample size, endpoints, or acceptability of alternative methodologies

• – It can also be useful after a previous negative assessment, to ensure the revised strategy addresses the notified body’s concerns.

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Two essential steps to establish a structured dialogue

🔹 Before signature of the conformity assessment application

At this early stage, interactions are typically informal, non-binding, and exploratory. Notified Bodies are not yet contractually obligated to provide detailed feedback. Therefore, topics should remain general, helping the manufacturer validate their overall regulatory approach.

Common topics include:

• ✅ Timelines for conformity assessment or possible special procedures, e.g. drug-device combinations, companion diagnostics or orphan devices 

• ✅ Clarification on the data to be submitted for the application

• ✅ Options and details of conformity assessment procedures 

• • ✅ Fees

  • • ✅ identification of MDN/MDA codes

  • • ✅ Applicable standards or guidance documents

    • • ✅ Process to obtain recommendations from the Expert Panel

      • • ✅ How leveraging evidence from previous submissions

        • • ✅ Qualification of medical device, accessory, WET, orphan device, etc.

          • ✅ Device classification

          • • ✅ Sampling of TD and review strategy

• ✅ Preferred structure of TD

📌 These discussions help manufacturers avoid misalignment early in the planning process, but are not part of the formal review.

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🔹 After signature of the conformity assessment application

Once the contract is signed and the application is lodged, the NB is formally engaged in the assessment process. Structured dialogue becomes a pre-assessment tool and is treated with greater procedural rigor. Discussions focus on clarifying specific documentation or technical points that will appear in the submission.

Common topics include:

• ✅ Information on new test reports

• ✅ Management of significant changes during the certification process

• ✅ Appropriateness of equivalence, PMCF Plan

• • ✅ Sufficiency of quality / quantity of clinical data

  • ✅ Applicability of Article 61(10)

  • • ✅ Clarification on non-conformities raised

📌 The objective is to align expectations in advance of the formal review or to minimize preventable deficiencies during the assessment phase.

How do you request a structured dialogue?

While there’s no EU-wide template, most notified bodies accept requests that include:

1️⃣ A cover letter or request form that explains:

• – The reason for the dialogue

• – The type of device and intended submission

• – The device-specific information, including description, intended use, mode of actions, etc.

• – The specific questions you’d like to clarify

2️⃣ Supporting documents (as needed):

• – Draft of supporting documents such as draft clinical evaluation plan, clinical investigation protocol or PMCF plan

• – Assumptions and specific justification (e.g., endpoints, equivalence rationale)

• – Diagrams, summaries, draft of IFU or flowcharts that illustrate your current thinking

3️⃣ A proposed format for the interaction:

• – Written-only exchange?

• – 1-hour online call?

• – Document-based review with written comments?

• A written summary of the meeting should be prepare and shared with the NB to formally document the key points discussed and the responses received during the structured dialogue.

What can you expect?

Structured dialogue is still new and not standardized across notified bodies. Here’s what to realistically expect:

✔ A limited-scope exchange, often addressing only 1 to 3 key questions
✔ Informal feedback from technical or clinical assessors—not a formal position
✔ A focus on general expectations, risk areas, or methodological concerns

Limitations and degree of uncertainty

Structured dialogue is a new concept—still under implementation and interpretation. As such, be aware of its limits:

🚫 It does not guarantee approval of your future submission
🚫 Feedback is not binding
🚫 NBs may decline or defer the request based on workload or scope
🚫 There is no harmonized process or timeline (expect variation across NBs)

🚫 The learning curve is essential to ensure structured dialogues remain compliant while still adding value. The boundary between a Notified Body’s role and prohibited consultancy is subtle, and staying within the permissible scope requires careful judgment. Notified Bodies are still adapting to this balance, learning how to provide sufficiently relevant and helpful information to manufacturers without crossing into advisory territory.

 

However, even with these limitations, early interaction can prevent misalignment and help you better anticipate questions during the formal review.

Best practices for manufacturers

• ✅Prepare thoroughly: Structure your request to present formal positions, supported by solid rationales and clear documentation. Proper preparation encourages focused feedback and helps avoid entering the prohibited realm of consultancy.

• ✅Use it strategically: Time your request wisely—ideally before significant technical or clinical investments—to validate your direction and prevent costly rework.

• ✅Be specific: Limit your request to 1 to 3 well-defined questions that address critical points of uncertainty.

• ✅Avoid generic or broad topics: Do not ask for a global review of your CER, PMS plan, or documentation. Instead, request confirmation of a justified position regarding a specific, documented issue.

• ✅Document everything: Capture and summarize the key points and responses discussed. Use this summary to draft written meeting minutes, which should be shared with the Notified Body to confirm mutual understanding and create a clear reference for the next steps.

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Conclusion

While the Structured Dialogue may not yet offer the same depth as the FDA’s Q-Submission (QSub) program, it represents a significant first step in improving communication between Notified Bodies (NBs) and medical device manufacturers under the MDR. It complements existing interaction channels, such as expert panel consultations, which are reserved for Class III and certain Class IIb devices, by offering a broader and earlier engagement opportunity for all device classes.

Structured Dialogue introduces a framework for early, targeted discussions, helping manufacturers clarify expectations and increase the predictability of success for MDR conformity assessments. Though still new and not fully harmonized across NBs, it provides a valuable strategic tool to proactively align with regulatory expectations before investing significant resources into a technical documentation file that may otherwise fall short of CE marking requirements.

In conclusion, we strongly encourage manufacturers to take advantage of this no-cost opportunity to interact with their NBs. To support you, LEXQARA provides a FREE cover letter template to initiate a Structured Dialogue request—available now in our Resource Center.

 

                                                                                                                                                                                                                               Alexandre Pétiard

 

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