The CSMD-Horizon Special Conference for MedTech AI and Digital Health: Regulation, Market Access and Clinical Evidence will take place on 4 and 5 November 2025 in Brussels, Belgium. This combined event brings together the established CSMD and Horizon conferences to focus on artificial intelligence, digital health technologies and software in the context of medical devices and in vitro diagnostics. The event offers practical insight into clinical evidence, evolving regulation and market access strategies, making it relevant for professionals in regulatory affairs, clinical affairs, R&D and related fields.
When and where is the conference?
The conference will run over two days, 4 and 5 November 2025, at a Brussels venue. Delegates will gather for keynote sessions, expert panels and practical workshops covering pressing regulatory and clinical issues for MedTech AI and digital health solutions.
What will the agenda cover?
The programme focuses on the clinical and regulatory challenges arising from AI and digital technologies in healthcare. Planned topics include:
- Clinical evidence requirements for digital health products from the perspectives of patients, payers and regulators.
- Navigating regulatory pathways for AI in medical devices while balancing innovation, risk management and patient access.
- Improving clinical study design for software-driven devices, with emphasis on engagement and data quality.
- Ethics and bias in AI-supported medical devices, addressing fairness and transparency.
- Real-world evidence and post-market surveillance, including the impact of software updates.
- Regulatory best practices and exploration of AI tools to streamline clinical investigations.
Who are the speakers?
Experts from multiple countries and sectors will join the podium. Confirmed speakers include Alberto Bardaji, Bethany Chung, Carlos Galamba, Sharmila Gardner, Danielle Giroud, Hugh Harvey, Simon Lidgate, Tom Melvin, Salvinia Mletzko, Natasha Motsi, Elisabeth Oltmanns, James Pink, Hatem Rabeh, Sally Sennitt, Nebojsa Serafimovic, Amie Smirthwaite, Monica Tocchi, Cécile van der Heijden, Anusha Venkatesan, Tom Willshare, and Sarina Zillikens.
These professionals bring experience from regulatory bodies, industry, academia and consultancy, covering diverse perspectives on MedTech AI and digital health regulation.
Who should attend?
The event is intended for regulatory and clinical leaders in the medical device and IVD sector. It will be especially relevant to specialists in clinical trials, reimbursement policy, regulatory compliance, quality management and product development. Networking opportunities will connect attendees with peers, regulators and innovators working in AI and digital health solutions for healthcare.
FAQ
- What is CSMD-Horizon?
It is a joint meeting combining the Conference on Clinical Studies with Medical Devices and IVDs (CSMD) and the International Conference on Clinical Investigations, Regulation, and Market Access for Medical Devices and IVDs (Horizon). - Is the event focused only on AI?
No. While AI is a major focus, the event also addresses digital health and software-based medical technologies in relation to regulation and clinical evidence. - Can non-EU participants attend?
Yes. The event welcomes delegates from all regions with an interest in MedTech regulation, clinical studies and digital health innovation. - Will there be networking sessions?
Yes. Attendees will have opportunities to meet colleagues and experts during the two-day programme. - Where can I register?
Registration is available via the conference website.
Key takeaways
The November 2025 CSMD-Horizon Special Conference offers a concentrated look at regulatory, market and clinical issues shaping AI and digital health products in the medical device sector. With two days of sessions in Brussels, and contributions from leading experts, the event provides both knowledge and networking value for professionals across the healthcare technology field.
Disclaimer
This article is for informational purposes only and holds no affiliation with the event organisers.
For more information or to book, visit: https://csmd-horizon.com/