As a partner of the NoBoCap community, VPH actively participated in the Annual NoBoCap Summit held in Brussels on 15-16 October 2025.
The summit gathered diverse medical device stakeholders to address the evolving EU regulatory landscape, particularly focusing on the Medical Devices Regulation (MDR) and the new AI Act, with a specific emphasis on supporting micro-small enterprises. VPH contributed with feedback on crucial topics like certifying software and AI as medical devices and the upcoming breakthrough medical device pathway. Key discussions centered on the need to move beyond conventional clinical studies by utilizing alternative evidence sources, such as registry data, real-world data, and in silico modelling, to reduce regulatory uncertainty.
The summit highlighted several key areas of ongoing regulatory work, including the proposed revision of the EU MDR/IVDR and the upcoming MDCG guidance on "Break Through Device." This guidance is particularly significant for the VPH community as it aims to facilitate conditional approval for disruptive technologies, like those from in silico medicine, by balancing pre-market and post-market evidence. Other major discussion points covered the interplay between the MDR/IVDR and the AI Act, the enhancement of structured dialogue, and community efforts for capacity building.
The VPH team maximized the opportunity to engage with representatives from the European Commission, Industry, and National Competent Authorities to advance medical device innovation.
Would you like to know more about the Breakthrough Devices or the insights on the state of play? Feel free to reach out to our Scientific Officer (janaki@vph-institute.org)
LINKS:
https://nobocap.eu/2024/06/25/summit-by-nobocap-community/
