As the regulatory landscape for medical devices and in vitro diagnostics (IVDs) in the European Union becomes more stringent, the need for transparent and efficient communication between manufacturers and notified bodies has never been more critical. The structured dialogue process, introduced through MDCG guidance, promises to enhance this communication, providing manufacturers with an opportunity to engage meaningfully with their notified bodies across the product lifecycle.

But what exactly is structured dialogue, and how does it fit into the broader regulatory framework?

What is Structured Dialogue?

Structured dialogue is a formalized communication framework designed to streamline interactions between manufacturers and notified bodies at all stages of the certification lifecycle. This process encompasses four key stages:

  1. Pre-application
  2. Application
  3. Conformity assessment
  4. Post-certification

It is not a new concept; however, its formalization provides manufacturers with a clearer path for regulatory interactions, helping to align expectations and reduce ambiguity throughout the product lifecycle.

The process offers multiple touchpoints where manufacturers can raise questions and clarify regulatory requirements, ensuring that both parties are aligned on what is expected. This can significantly reduce the time and effort required to gain certification, particularly for newer manufacturers or those developing high-risk or innovative devices.

 

The Role of Notified Bodies

Notified bodies are crucial players in the structured dialogue process. They facilitate the dialogue but remain within their regulatory boundaries, offering insights into regulatory expectations without crossing into consultation. This distinction is critical, as notified bodies cannot provide specific guidance on how to achieve conformity but can clarify regulatory requirements and outline potential pathways to compliance.

Although interactions and communications between a manufacturer and a corresponding notified body are neither new nor uncommon, different notified bodies, such as BSI, TÜV SÜD, and GMED, have established structured dialogue frameworks tailored to their operations. These frameworks typically involve scheduled meetings where manufacturers can present their questions and receive feedback from the notified body. These dialogues often include discussions on technical, administrative, and regulatory matters, depending on the stage of the conformity assessment.


Hear directly from representatives of BSI, TÜV SÜD, and GMED and watch the on-demand presentation (including their frameworks mentioned above) and panel discussion, RQM+ Live! #83 – Structured Dialogue: How to Engage with Notified Bodies.

RQM+_Live_83_On_Demand

Watch Recording and Download Slides ️️


Benefits of Structured Dialogue

One of the main advantages of structured dialogue is the opportunity it provides for manufacturers to gain clarity on expectations early in the process. While there appear to be no KPIs to measure the success of such interactions, by engaging in pre-application discussions, manufacturers can ensure their submissions meet the regulatory requirements, potentially reducing the likelihood of non-conformities later in the review process. This is particularly valuable for small and medium-sized enterprises (SMEs) or those new to the EU regulatory system, as it helps them navigate the complexities of compliance more effectively.

Moreover, structured dialogue can also be beneficial during post-certification activities, such as periodic safety update reports (PSURs) or change modifications. By maintaining open communication with notified bodies, manufacturers can address these requirements proactively, minimizing delays in market access.

Challenges and Limitations of Structured Dialogue

Despite its benefits, structured dialogue is not without its challenges. One of the primary concerns is the inability of notified bodies to consult directly with manufacturers. While they can provide valuable feedback on regulatory requirements, they cannot advise on specific device-related decisions.

This limitation means that manufacturers must come prepared with a solid understanding of their product and the regulatory landscape.

Additionally, the process requires manufacturers to take an active role in documenting the outcomes of these discussions. Meeting minutes and other documentation must be carefully reviewed and agreed upon by both parties, ensuring that all interactions are traceable and transparent.

Looking Ahead

As the structured dialogue process continues to evolve, it is expected to play an increasingly important role in the EU regulatory framework. While it is currently an optional tool, perhaps, it may become a mandatory step for high-risk devices in the future. The ultimate goal of structured dialogue is to enhance regulatory efficiency, helping to bring innovative medical devices and IVDs to market more quickly without compromising safety or quality.

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