From Uncertainty to Clarity: The Impact of Structured Dialogue in MDR Assessments

At Kiwa Medical, we see every day how valuable these dialogues are in creating a predictable, transparent, and efficient conformity assessment process, while strictly maintaining our independence and impartiality. Especially for our clients, who are a small or medium-sized enterprise (SME)

Structured dialogues are a formalized exchange focused on what regulatory requirements must be fulfilled, not how to fulfil them. MDCG 2019-6 Rev.5 describes it as a communication mechanism to clarify processes, timelines, required documentation, and expectations throughout the pre-application and post-application phases. 

Key Benefits for Manufacturers:

• A clear overview of the certification process 
• Early insight into timelines, sampling, audits, and documentation needs Predictability through clarification on clinical evidence, equivalence claims, or PMCF expectations
• Transparency on pricing, procedural steps, and involved personnel
• The opportunity to understand how previous assessments or existing data may be leveraged

Our Experience in Practice 

At Kiwa Medical (NB 1912) we are supporting our clients with the MDR Start-up Support Program MDR Start-up support program, which also includes after each pre-application and application a structured dialogue. Since January 2025, we have launched this approach, with great success. These meetings, which typically take 30 to 45 minutes, help us and our clients to align early, clarify expectations, and improve communication throughout the process. 

Pre- and Post-Application Structured Dialogues

Besides pre-application structured dialogues, we also scheduled several post-application structured dialogues in which we align with our customers on clarity of non-conformities and early discussion on a planned substantial change of a product and the consequences for the certification process. Clients appreciate the responsiveness, transparency, and predictability. We gain early insight into submission quality and readiness and together, we create a more efficient, constructive and pleasant certification process.