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.