Structured dialogue is the essential tool to optimise your medical device’s pathway towards the MDR certification.

By engaging in a transparent and impartial structured dialogue with our Notified Body No.1282, you can improve documentation readiness, align expectations, and streamline every phase of the MDR certification process.

In today’s regulatory landscape, navigating the EU Medical Device Regulation (MDR 2017/745) can be complex and demanding. One of the most effective tools available to manufacturers to streamline this process is structured dialogue — a formalized exchange that fosters transparency, clarity, and efficiency throughout the conformity assessment journey.

WHAT IS STRUCTURED DIALOGUE?

Structured dialogue is a proactive and organized communication process between the Notified Body and the manufacturer, taking place before and during the conformity assessment procedure. Its main goal is to provide clarity on what needs to be fulfilled – not how to fulfill it – ensuring the manufacturer is well-prepared while preserving the independence and impartiality of the Notified Body.

HOW STRUCTURED DIALOGUE WORKS

As clarified in MDCG 2019-6 Rev.5, structured dialogue typically includes:

1) Pre-application phase

A comprehensive overview of the certification process, including both the pre-application and application phases:

• Timelines for conformity assessment
• Acceptable languages, formats and required forms
• Documentation requirements and timing for submission
• Options on conformity assessment procedures
• Applicable standards and regulatory guidances
• Information related to the contractual relationship (pricing, fees and terms).

2) Post-application phase

A focused discussion on regulatory and technical aspects such as:

• Sufficiency of clinical evidence
• Timelines for providing missing or additional data
• Information on substantial changes and consequences
• Applicability of Article 61(10) MDR
• Claims of equivalence
• Clarification of non-conformities
• Appropriateness of PMCF (Post-Market Clinical Follow-up) plans.

All structured dialogue discussions must be documented by the Notified Body, in line with MDCG recommendations, to ensure transparency and traceability.

BENEFITS OF STRUCTURED DIALOGUE

Engaging in structured dialogue with a Notified Body, such as ECM – Ente Certificazione Macchine NB 1282, can bring significant advantages:

• Enhanced regulatory awareness
• Optimized submission strategy
• Early alignment on technical expectations
• Reduction in wasted time due to errors or requests for additional data.

Ultimately, structured dialogue supports a more predictable and efficient conformity assessment process, while fully respecting the role and impartiality of the Notified Body.

PARTNER WITH ECM FOR YOUR MDR CERTIFICATION JOURNEY

At ECM, we believe that clear and structured communication is the cornerstone of a successful certification. That’s why we offer a professional structured dialogue service to our clients — helping them to clarify critical elements before the formal submission and throughout the entire assessment process.

Start a structured dialogue with ECM today:

Diego Stevanella – diego.s@entecerma.it
Marzia Pellegrini – marzia.p@entecerma.it