The transition from the MDD Directive to the MDR Regulation (EU) 2017/745 redefined the compliance criteria for medical devices, increasing documentation complexity and evaluation times. In this scenario, the European guidelines (MDCG 2022-14) introduced the ‘Structured Dialogue’, a fundamental pillar for optimizing certification processes and reducing time-to-market, without compromising evaluative rigor.

WHAT IS THE STRUCTURED DIALOGUE

It is a formal and planned communication channel between the Manufacturer and the Notified Body. Its primary purpose is to clarify the evaluation process, timelines, and expected regulatory requirements. This exchange strictly excludes any consultancy activities: the Notified Body clarifies what the regulation states and how the process is structured, leaving the exclusive responsibility of how to comply to the manufacturer.

ADVANTAGES FOR MANUFACTURERS

Structured dialogue translates into a drastic reduction in uncertainty. It allows companies to plan product development and launch with greater precision, reducing the cycles of questions and answers (the so-called ‘clock-stops’) during the review of technical documentation. Knowing the Notified Body’s expectations in advance makes it possible to submit more complete and robust dossiers.

PHASES AND FIELD APPLICATION

The process unfolds at key moments: during the pre-application phase, to verify dossier readiness and the correct classification of the device; and in the post-application phase, to clarify the nature of any identified non-compliances. Targeted sessions and shared deadlines transform the regulatory process into a linear, secure, and transparent path for the entire healthcare ecosystem.