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

For manufacturers seeking to navigate the certification process under Regulation (EU) 2017/745, structured dialogue with the Notified Body is a key tool. The European Commission itself, in the Position Paper MDCG 2022-14, highlighted the importance of organizing such dialogues to enhance the efficiency and predictability of the conformity assessment process. This recommendation underscores the value of a structured-based approach to optimize certification procedures, benefiting both manufacturers and Notified Bodies.

OPTIMIZE YOUR CERTIFICATION PROCESS

The structured dialogue is the formal process that allows manufacturers to clarify, in advance, procedural details, timelines, and regulatory aspects relevant to the certification process, based on the type, risk class, and specific characteristics of the medical device to be certified under the MDR.

The information exchange is generally based on meetings planned prior to the formal request for conformity assessment. While maintaining the independence and impartiality of the Notified Body, the structured dialogue has proven to be an effective methodology to optimize all planned steps of the certification process, maximizing its fluidity and avoiding incomplete submissions.

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.

DISCOVER THE BENEFITS FOR MANUFACTURERS

For manufacturers, being aware of the procedural and regulatory aspects of the certification process is crucial to confidently addressing complex issues, such as defining an effective clinical strategy. This awareness enables manufacturers not only to assess the validity of their strategy based on the device concerned, but also to define specific aspects related to clinical data, demonstration of equivalence, the possibility of demonstration of conformity to relevant GSPRs without clinical data (Art. 61 (10) of the MDR) as well as aspects related to surveillance (PMS) and post-marketing clinical follow up (PMCF).

CONTACT US TO START A STRUCTURED DIALOGUE

If you wish to engage in a structured dialogue with the aim of optimising 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