What is a structured dialogue?
A structured dialogue is a conversation between a notified body and a manufacturer applying for conformity assessment that relates to technical information and regulatory guidance. The Medical Devices Conformity Group (MDCG) guidance encourages Structured Dialogues, provided that they are conducted in a way that respects independence, impartiality, and compliance.
At Scarlet, structured dialogues are conducted online via video conferencing.
They are generally conducted on the basis of:
A Scarlet document template that a manufacturer has populated before the call, providing a representative sample of data to demonstrate their understanding of regulatory concepts
Supporting material Scarlet has made available to all manufacturers covering key regulatory concepts
What is the purpose of a structured dialogue?
The purpose of structured dialogues is to ensure efficient assessment.
Structured dialogues:
Offer a clear framework for discussing regulatory requirements in an organised manner.
Provide opportunities to discuss regulatory approval processes and expectations before an application is submitted.
Facilitate the submission of well-prepared applications for efficient conformity assessments.
Structured Dialogues are NOT a consultation service and are part of Scarlet’s application and conformity assessment process.
What is discussed in a structured dialogue?
The guiding principle for structured dialogues is that Scarlet will not provide specific advice. Conversations will be focussed on “what needs to be fulfilled” rather than “how to fulfil”.
Below is a non-exhaustive list of topics that can be covered in a structured dialogue:
Comprehensive overview of certification process.
Leveraging evidence from previous assessments.
Clarification of the data / documentation to be provided with the application.
Information on all necessary conformity assessment activities.
General requirements regarding and acceptance of (third party) test reports / certificates.
Requirements for sampling of devices for technical documentation assessments.
Best practice guidance for technical documentation including preferred structure.
Sufficiency of clinical data on which a clinical evaluation is based, including:
possible applicability of Art 61(10) MDR;
equivalence of the device under assessment with another device;
appropriateness of the post-market clinical follow-up plan.
Clarification of missing data.
Next steps regarding the submission of new test data.
Timelines for providing additional missing data.
What are the benefits of structured dialogues?
The key benefit of structured dialogues is that it enhances efficiency in the submission and assessment process.
It introduces regular touch-points in the application and assessment process to ensure ongoing alignment between the expectations of the manufacturer and the notified body.
Speed comes from being prepared, not cutting corners. We ensure manufacturers have the relevant regulatory information at the right time so they don’t waste time fixing preventable mistakes.
They help manufacturers to focus on the right level of detail. Too little information leads to delays, and too much irrelevant data creates unnecessary complexity. Discussions help strike the right balance.
Making the most of your structured dialogues with Scarlet
Before your structured dialogue, you will be provided with a template to enter data regarding your product in.
The content of the template should contain a representative sample of your data for any given regulatory topic, not a complete list. The detail provided may vary depending on your progress through the application process. This is to maintain Scarlet’s commitment to impartiality and avoid gap analysis or conformity assessment activities prior to submission completion.
Complete the template as described above and send it to Scarlet ahead of your structured dialogue. This allows our team the opportunity to review the information ahead of time so that we can make the call as productive as possible.
The information you provide for a structured dialogue is not part of your application. You may re-use and re-purpose some of the information, but the initial information provided by customers will not be considered in your assessment.
Summary - key points
Structured dialogues provide a structured way for customers to interact with and ask questions of Scarlet assessors.
Structured dialogues are discussions, not consultations.
Structured dialogues promote efficiency and predictability by helping customers to understand and be prepared for the process of submission and assessment.