1.    What is Structured Dialogue?

Structured dialogue is a collaborative process between a notified body and a manufacturer. It is a forum where the notified body explains the requirements of the regulation,  reviews mature plans by a manufacture for device submission, and where transparent insight into the application and conformity assessment process is outlined. Ultimately, the objective is to facilitate the submission of complete and compliant documentation for conformity assessment with a final aim to expedite the delivery of safe and effective medical devices to the EU market.

We offer this service to manufacturers to support their application and device certification. The activity is part of the routine services and is offered when a dialogue may be needed. The scope of a structured dialogue is to clarify timelines, certification procedures, regulatory aspects, and requirements on the submission of documents. It is important to note that as a notified body we have an obligation to remain impartial, and as a result we may not consult and will refuse any activities that we deem to be consulting.

 At QMD Services, we want our cleints to experience the best possible service in terms of our responsiveness and meeting timeliness, have access to easy-to-use tools, and simplicity in our processes. We aim be rated as “best in class” by our clients.

 2.    Who is this service for?

A structured dialogue is most beneficial for manufacturers:

 •              with no or little experience in conformity assessment

 •              with an extended product portfolio, aiming for synergies and sampling

 •              requiring special procedures (Consultation, EU-Reference Labs, etc.)

 •              SMEs and Start-ups

 •              Organisations with time/budget constraints, trying to prepare optimally for conformity assessment, to avoid several rounds of conformity assessment

 SMEs, even if not yet QMD Services clients, are expressly welcome!

  3.    Topics for Structured Dialogue

Application Procedure

 •        Pre-application process

 •        Application process and document requirements

 •        Device classification & code assignment

 •       QMS requirments

 •        Sites, suppliers & devices in the conformity assessment process

 •        Costs, fees & and payment aspects

 •        Contract and Terms and Conditions

 •        Transfer to QMD Services as Notified Body

 Conformity Assessment Procedure

 •        Project planning, time limits, and process to complete deficiencies/open questions

 •        TD Submission requirements

 •        QMD Conformity Assessment procedures

 •        Common Specifications, guidance documents & harmonized standards

 •        Handling of changes

 •        Special procedures (e.g. consultation, reference laboratories, batch releases, etc.)

  4.    How are the meetings structured?

A structured dialogues takes place typically in the form of (virtual) meetings. A clear agenda will be set prior to a meeting. Any questions the manufacturer would like to discuss should be raised in writing in advance . Manufacturers would be best served if they provide sufficient insight into their devices and operations in advance, as this will help to indicate the maturity of their preparations for conformity assessment.

  5.    How to request the service?

For existing clients, please make contract directly with your assigned Project Leader. For new clients, please submit a request for service through our web form.

  6.    References

1.    MDCG 2022-14. EU Medical Device Coordination Group Position Paper. Encourages structured dialogues before and during the conformity assessment process.

 2.    MDCG 2022-11 Revision 1. MDCG Position Paper on pre-application activities. Clarifies that structured dialogues should be part of normal pre-application and conformity assessment activities and not charged separately.

 3.    Team-NB Guidance. IVDR Technical Documentation Guidance by Team-NB. Provides best practices for preparing technical documentation and emphasizes early communication between manufacturers and notified bodies.