Registration is now open for the SHAIPED Stakeholder Forum: Advancing AI Medical Devices in the European Health Data Space (EHDS), taking place on 5 October 2026 at ParisSanté Campus in Paris, with the possibility to join online.
How can Europe create a more effective ecosystem for developing, validating and deploying AI Medical Devices?
The SHAIPED Stakeholder Forum will bring together regulators, Health Data Access Bodies (HDABs), HTA organisations, Notified Bodies, healthcare professionals, researchers, industry representatives, European initiatives and other stakeholders to explore this question from different perspectives.
The Forum is designed as an interactive space for dialogue and exchange. Rather than a series of traditional presentations, the afternoon will focus on practical experiences, different stakeholder perspectives and open discussion on the challenges encountered when developing and bringing AI Medical Devices into real-world healthcare settings.
Participants will be encouraged to share their experiences, respond to perspectives from other stakeholder groups and contribute directly to the discussion through live audience polling, open Q&A and interactive exchanges.
Two sessions, one shared discussion
The programme will feature two complementary sessions.
Ecosystem Dialogue – Making Europe Developer-Friendly for Medical AI
The first session will bring different parts of the European medical AI ecosystem into direct conversation. Industry, regulators, Notified Bodies, HTA organisations, HDABs and healthcare representatives will exchange views on the practical realities of developing and bringing AI Medical Devices to the European market.
The discussion will explore where stakeholders currently encounter barriers, how different regulatory and organisational requirements interact in practice, and where greater alignment or support could help innovation move forward.
Data Readiness Reality Check: Is the Data Actually AI-Ready?
The second session will shift the discussion from regulatory pathways to the data needed to develop, validate and evaluate AI.
Short Lightning Pitches from European initiatives will introduce real implementation experiences, followed by a multi-stakeholder roundtable on what it actually takes to make health data usable for AI. The conversation will address practical experiences with data quality, interoperability, secondary use of health data, Real-World Data and Real-World Evidence, privacy and data utility.
Audience participation will be an important part of both sessions, helping to identify shared challenges, different perspectives and priorities for future action.
Join the conversation
Whether you work in regulation, healthcare, research, health data, technology or the development and evaluation of AI Medical Devices, the Forum offers an opportunity to exchange experiences with stakeholders from across Europe, contribute your perspective and connect with others working on similar challenges.The discussions will also help inform the ongoing work of the SHAIPED project and its efforts to develop practical pathways for AI Medical Devices within the evolving European health data ecosystem.
Time: 14:30–18:00 (registration and coffee from 14:00)
Participation: On-site or online
The afternoon will conclude with a plenary wrap-up followed by drinks and networking, providing further opportunity to continue the conversations and connect with other participants.
The preliminary agenda is available here.
Registration is now open
We invite you to join us in Paris or online and add your experience and perspective to the conversation.
Please note that on-site participation is limited due to venue capacity. If on-site capacity is reached, participants may be offered the possibility to join online.