The webinar on Clinical Evaluation in the MDR organised by RAPS Quebec LNG attracted wide participation, confirming the interest in key topics related to compliance with regulatory requirements.

On 24 February 2025, ECM participated as the sole speaker in the webinar “Clinical Evaluation under MDR explained by a Notified Body”, organized by RAPS Quebec Local Networking Group. The initiative generated strong interest among manufacturers and industry professionals, with over 120 registrants and active participation that remained consistent until the end of the event. The webinar also generated a large number of questions from the audience, confirming the high level of interest in the topics discussed.

TECHNICAL INSIGHTS ON CLINICAL EVALUATION UNDER MDR

The webinar delved into some key aspects related to the clinical evaluation process of MDR 2015/745. In particular, Riccardo Persia, Clinical Manager at ECM, explained the fundamentals and methodological principles underlying the clinical evaluation process:

• Article 61(10) of the MDR and the regulatory obligations for demonstrating compliance with general safety and performance requirements in the absence of clinical data;
• The provisions of the MDCG 2024-10 guideline regarding the clinical evaluation of ‘orphan’ medical devices.

ONGOING INTEREST IN COMPLEX ISSUES

The high number of registrants and the level of interest among participants demonstrate how essential it is to address the more complex issues related to clinical evaluation under MDR in a clear and professional way. ECM’s commitment as a Notified Body also involves providing, in addition to certification activities, accurate and updated information to ensure companies have a better understanding of regulatory complexities.

A REFERENCE EVENT FOR THE SECTOR

Events like this represent a key opportunity for medical device manufacturers and industry professionals, offering concrete tools to better understand and optimally apply regulatory requirements. The success of this initiative highlights the importance of continuing to promote moments of discussion and in-depth exploration of clinical evaluation and other MDR requirements.

To stay updated on upcoming events and topics of greatest interest in the certification sector, follow us on LinkedIn or contact our Sales team:

Diego Stevanella: diego.s@entecerma.it

Marzia Pellegrini: marzia.p@entecerma.it