UK PMS Regulations for Medical Devices - Part 3 UK PMS Regulations vs EU MDR

Structured Dialogue

Plan smart. Discuss early. Certify efficiently


Structured Dialogue for Medical Device Manufacturers

Enhancing Transparency – Supporting Your Regulatory Journey

At DQS, we understand that navigating the regulatory landscape under Regulation (EU) 2017/745 (CE Marking for Medical Devices in Europe or MDR), ISO 13485, or MDSAP can be complex and challenging. Our Structured Dialogue service provides a formal, impartial format for manufacturers to clarify procedural expectations and regulatory requirements, while maintaining full compliance with European legislation and notified body obligations.

 

What Is Structured Dialogue?

Structured Dialogue is a non-binding, formal interaction between DQS regulatory experts and manufacturers. It is designed to increase transparency, reduce delays, and ensure a shared understanding of conformity assessment expectations without offering consultancy or strategic advice. The format follows MDCG 2019-6 Rev.5 and fully complies with MDR Annex VII, 1.2.9, which prohibits notified bodies from providing consultancy.

The focus is:

🟢 What needs to be fulfilled 🔴 Not: How to fulfill it

When Is It Useful?

Structured Dialogue is suitable for both new and existing clients at various stages of the regulatory lifecycle. It can be conducted before (i.e., pre-application) and during the conformity assessment process (i.e., post-application). Typical topics may include administrative aspects, regulatory requirements, or technical questions such as:

Pre-Application

  • Verification of whether the product falls under the scope of the Regulation

  • Overview of the certification process and assessment activities

  • Clarification of which documentation must be submitted, and at which stage during the assessment

  • Best practice guidance for preparing technical documentation

  • Device classification and identification of relevant MD codes

Post-Application

  • Exchange of views on the sufficiency of clinical data and clarification of missing or insufficient data

  • Early discussion on a planned significant product (design) change and its impact on the certification process

  • Reuse of evidence from previous assessments (where applicable)

  • Evaluation of the appropriateness of the PMCF plan

  • Clarification of non-conformities raised during the assessment

Engaging in Structured Dialogue early in the process offers a valuable opportunity to increase transparency and predictability throughout the conformity assessment. It enables manufacturers to gain early insights and reduce uncertainty, without compromising the independence or impartiality of the notified body.

MED Blog ISO 13485 - Clauses excluded not applicable

What Can Be Discussed?

✔ Interpretation of applicable standards and regulatory requirements
✔ Clarification of DQS procedures, timelines, and documentation handling
✔ Expectations for structure and content of submissions
✔ Overview of conformity assessment pathways

What’s excluded:

✘ Strategic or product-specific advice
✘ Gap analyses or documentation reviews
✘ Draft assessments or technical evaluations
✘ Clinical, design, or risk strategy guidance

 

How It Works

Request Submission

Clients submit requests via our digital form

Topic Validation

DQS confirms eligibility and ensures impartiality.

Expert Assignment

Experts are assigned based on your request.

Session Execution

Held online or in person, based on a structured question set submitted in advance by you.

Documentation

Each session is recorded using a standarized protocol, including a summary.

Delivery & Archiving

You will receive a summary, and all records are archived for full traceability.

Commercial Terms

Each Structured Dialogue session has a minimum duration of one hour and is billed at €400 per hour, excluding applicable VAT and any additional costs for any additional external expert. DQS will assign the appropriate representatives for each session, which may include a Customer Service Representative and/or Regulatory Affairs Manager, and/or a Technical Reviewer or Clinical Expert.

A review and preparation fee of €150.- Euros applies for the assessment of the application and agenda of your Structured Dialogue. This fee covers the evaluation of the submitted materials by our experts and the preparation of the session framework. If the Structured Dialogue is confirmed, this amount will be fully deducted from the final invoice.

Cancellations made more than 48 hours before the scheduled session will incur a cancellation fee of €200. Cancellations made within 48 hours of the scheduled session will be charged at the full agreed session price.

Ready to book your Structured Dialogue session?

Use our online request form to get started, or contact your DQS representative for more information. After your submission, we will provide you with a list so that you can send us your goals and questions in order to arrange the agenda for your Structured Dialogue.