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Structured Dialogue Cover Letter

Regulatory communication template

Structured Dialogue Cover Letter for medical device regulatory correspondence

Use this editable Structured Dialogue Cover Letter to structure formal communication with regulators, notified bodies and other stakeholders.

Structure submissionsPresent requests and responses clearly and consistently.
Maintain traceabilityKeep a record of regulatory dialogue and decisions.
Support complianceAlign correspondence with MDR/IVDR procedural expectations.

  • Best for: regulatory correspondence, structured dialogue, submission cover letters and stakeholder communication.
  • Includes: editable sections for recipient, subject, background, request and supporting references.
  • Format: editable template available through the standard WooCommerce download flow.
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Lexqara supports manufacturers in managing regulatory communication with clarity and traceability. Explore the Resource Center or review our Regulatory Strategy Services.

Description:
This form supports a formal request to a Notified Body to initiate a structured dialogue and document the scope, inputs, and questions.

  • Capture the request basis per MDCG 2019-6 rev.5 and define Pre-application/Post-application context.

  • Identify the device with Device Name, Basic UDI-DI, and Device Classification (Class/Rule).

  • Define the dialogue objective and expected outcome for the conformity assessment procedure.

  • List Supporting Documentation (document number, revision, title) to enable an efficient review.

  • Record Device description and key elements for discussion (e.g., mode of action, materials).

  • Structure Intended use, Indication, Targeted patient population, and Contra-indications.

  • Formalize non-open-ended questions linked to an attached position paper and confirm “no consulting / no pre-approval”.

Your needs:

  • Structured dialogue request

  • Structured dialogue request for MDR decision-making

  • Reduce rework, delays, and deficiency cycles with the Notified Body

Use this template when you need a controlled, repeatable way to request and prepare an EU structured dialogue with your Notified Body before or during conformity assessment.

It ensures your request is audit-friendly and actionable. Structured dialogue is a defined exchange to clarify regulatory expectations without seeking consultancy. A position paper is your documented rationale that anchors each question and supporting evidence.

  • Identify application stage and intended timeline (submission/response round)

  • Provide device identifiers and proposed classification details

  • Submit a complete supporting documentation list

  • Describe device critical elements relevant to the topic

  • Define intended use and clinical context boundaries

  • Ask clear, closed questions tied to your justification

  • Propose format (written/call/review) and time slots

Within Lexqara, we help you prepare defensible dialogue packs (position papers, technical documentation alignment, QMS readiness, and submission strategy) while keeping roles clear with the Notified Body. Visit our Resource Center and our Regulatory Strategy support, and align your request with MDCG 2019-6 Rev.5. Download the template and request a short gap assessment.

Template preview

Template preview: Structured Dialogue Cover Letter

Review the key sections included in the Structured Dialogue Cover Letter template before downloading it. This preview shows the structure and content you will receive in the editable file.

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[Company Name]

[Address]

[Phone]

[Email]

[Website]

To:

[Notified Body Name]

[NB Address]

Subject: Request of structured dialogue

Dear,

We are submitting this request in accordance with the MDCG 2019-6 rev.5 guidance document to initiate a Structured Dialogue regarding our upcoming/lodged conformity assessment procedure for the following device:

Device Name: XXX

Basic UDI-DI: XXX

Device Classification: Class XX under Rule XX

Type of Application: Pre-application/Post-application

Planned NB Submission/ NB Response (Round X) Date: XXX QY; DD/MM/YYYY

Suggestions:

  • Pre-application

We wish to initiate this structured dialogue in order to XXX shorly explain the objective of the structured dialogue. This proactive exchange aims to consolidate our overall regulatory approach for CE marking / clarify the process to formally lodged an application /estimate the current timelines and steps of the conformity assessment procedure.

  • Post-application (before submission)

Following the lodging of our application, we are requesting a structured dialogue this structured dialogue in order to XXX shorly explain the objective of the structured dialogue. This proactive exchange aims to address our concern promptly, consolidate our position and avoid unnecessary delays or deficiencies during the conformity assessment procedure.

  • Post-application (during submission)

Following the submission of our Technical Documentation (TD) / the audit of our Quality Management System (QMS) as part of the conformity assessment procedure, certain non-conformities have been raised. We are requesting a structured dialogue to address these issues promptly, strengthen our position, and prevent unnecessary delays or additional findings.

Regards,

Name: XXX

Date: DD/MM/YYYY

Function: XXX

signature

Supporting Documentation

For the effective implementation of the structured dialogue, we have enclosed the following supporting documents.

Document number

Revision

Document Title

Device Description

XXX Include the description of the product, including the critical elements for the dialogue (e.g. representative pictures, mode of action, raw materials)

Device intended use

3.1. Intended use

Include the intended use statement or propose a relevant intended use for which the dialogue will be based on.

3.2. Indication

Include the indications for use statement or propose relevant indications for which the dialogue will be based on.

3.3. Targeted patient population

Remove if not relevant for the evaluation. Include the targeted patient population or propose relevant patient populations for which the dialogue will be based on.

3.4. Contra-indications

Remove if not relevant

Questions for the structured dialogue

We are seeking your confirmation of alignment with our documented position and any feedback regarding its acceptability in the context of the conformity assessment. Our request focuses on the following specific points (detailed in the attached position paper):

  1. XXX Details of the issue with manufacturer position and justification

Question 1: Clearly formulated, non-open-ended question Does [Notified Body name] agree with our proposed justification for XXXX.

  1. XXX Details of the issue with manufacturer position and justification

Question 2: Clearly formulated, non-open-ended question Does [Notified Body name] agree with our proposed justification for XXXX.

  1. XXX Details of the issue with manufacturer position and justification

Question 3: Clearly formulated, non-open-ended question Does [Notified Body name] agree with our proposed justification for XXXX.

We confirm that this dialogue is intended to clarify regulatory expectations, not to obtain consulting advice or pre-approval.

Additionally, we remain open to any further observations, comments, or clarification requests that may arise from your review, with the aim of reinforcing alignment and facilitating a smooth structured dialogue.

Proposed format and dates

To address the questions outlined above, we propose the following format for the structured dialogue:

Written only exchange

1-hour video call

1-hour online call

Document based review with written comments

Other:

Our preferred dates and time slots are as follows. We remain flexible and open to any alternative suggestions that better suit your availability:

Recommend including at least 3 proposed slots

  • DD/MM/YYYY from XX:XX to YY:YY
  • DD/MM/YYYY from XX:XX to YY:YY
  • DD/MM/YYYY from XX:XX to YY:YY

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