Optimize the MDR certification process through effective and transparent structured dialogue, while respecting the independence of the Notified Body.

For manufacturers seeking to navigate the certification process for their medical devices under Regulation (EU) 2017/745, structured dialogue with the Notified Body is a key tool. The European Commission itself, in document MDCG 2022-14, has highlighted the importance of organizing such dialogues to improve the efficiency and predictability of the conformity assessment process. This recommendation reflects the importance of a structured approach to optimizing certification procedures, benefiting both manufacturers and Notified Bodies.

STREAMLINE YOUR CERTIFICATION PROCESS

Structured dialogue represents the formal process that allows for the early clarification of procedural details, timelines, and relevant regulatory aspects of the certification route, based on the type, risk class, and specific characteristics of the medical device to be certified under the MDR.

Information exchange is generally based on meetings planned prior to the formal application for conformity assessment. While maintaining the independence and impartiality of the Notified Body, Structured Dialogue constitutes an effective methodology to optimize all phases of the certification process and maximize its fluidity, for instance by avoiding incomplete applications.

The purpose of these meetings is to prevent potential obstacles by facilitating a better understanding of all procedural aspects that affect the efficiency of the certification process.

EXPLORE THE ADVANTAGES FOR MANUFACTURERS

For manufacturers, being aware of the procedural and regulatory aspects of the certification route is crucial for confidently addressing complex issues, such as defining an effective clinical strategy. This awareness would allow manufacturers not only to assess the validity of their strategy based on the device under consideration, but also to master specific aspects related to clinical data, the demonstration of equivalence, and the possibility of demonstrating conformity to general safety and performance requirements without clinical data (Art. 61(10) of the MDR), as well as post-market surveillance (PMS) and post-market clinical follow-up (PMCF).

CONTACT US TO INITIATE A STRUCTURED DIALOGUE WITH OUR TEAM

If you wish to initiate a structured dialogue to optimize the MDR certification process for your medical device, please contact our Notified Body No. 1282 – Ente Certificazione Macchine, through our Sales Division: Diego Stevanella (diego.s@entecerma.it) and Marzia Pellegrini (marzia.p@entecerma.it).