Day Four – 19 June 2025 - CEST Time Zone
- Elizabeth Gfoeller - Corporate Director, Regulatory Affairs, MED-EL
What are the newest pieces of legislation which have been released relating to software and AI/ML in Europe?
What have the biggest impact on industry?
What's in the pipeline?
Regulatory priorities for the next year
- Malte Knowles Schmidt - Manager Global Service Portfolio SW, AI and Cybersec. for Medical Devices, TÜV SÜD
- Alexander von Janowski - AI Certification Manager, TÜV AI.Lab
- UK’s position on AI innovation
- How the UK’s approach to AI devices is shaping up
- The role of international reliance in deploying AI globally
- EU’s position on AI innovation
- The impact of the EU AI Act on new devices
- A global look ahead
- Emerging regulatory trends in AI regulation and their ramifications
- James Dewar - Co-founder & CEO, Scarlet
Latest regulatory updates from the US
How different are they from European updates?
Are there places of alignment between the 2 regions?
Where can manufacturers streamline documentation or workload?
The future
US priorities for software and AI/ML in the coming year
- Paula Antunes - Portfolio Lead, Regulatory in Digital Health and IVD, Novo Nordisk
Manufacturer obligations for medical AI systems
MDR and AI Act requirements regarding explainability and transparency
Operator obligations for medical AI systems
German and European operator law
Implementation of obligations in inactive processes of manufacturers and operators
- Thorsten Prinz - Senior Medical Devices & Software Manager, VDE Verband der Elektrotechnik Elektronik Informationstechnik e.V.
In this opening half an hour, take the time to reflect on your current software and AI journey and discuss with colleagues
Use the post-it notes provided to write down your top comment, question or concern
These will then be addressed by our expert panel during tomorrow’s final session
Comparison of cybersecurity legislation from both Europe and the US
How do they compare?
Are there places in which one can learn from the other?
How can manufacturers adhere to both sets of regulations, if operating in both regions?
- Tips for best practices
Risk and mitigation techniques for cybersecurity
Dealing with breaches
- Stephen Gilbert - Professor of Medical Device Regulatory Science, Else Kröner Fresenius Center for Digital Health, Technische Universität Dresden
- Sravani Sreeram Nagasai - Technical Program Manager, Google
- Oscar Freyer - Research Associate at the Professorship for Medical Device Regulatory Science, Else Kröner Fresenius Center for Digital Health, Technische Universität Dresden
- Elizabeth Gfoeller - Corporate Director, Regulatory Affairs, MED-EL
- AI in MedTech: legal and regulatory pathways
An overview of the legal landscape shaping AI and software in medical technologies, with a focus on key EU frameworks such as the AI Act, MDR/IVDR, and GDPR. The session will explore how evolving regulation is influencing innovation, market access, and clinical integration. - Cybersecurity and digital sovereignty
Key considerations for building legally compliant and trusted digital health infrastructure in Europe, including governance of sensitive health data, cross-border interoperability, and alignment with national digital strategies. - Delivering compliant innovation globally
A look at how legal, privacy, and ethical requirements are being embedded in the development and deployment of AI-driven healthcare solutions, and the practical implications for stakeholders across the digital health ecosystem with a global approach.
- Gunnar Sachs - Partner, Healthcare & Life Sciences, Clifford Chance
- Patrice Navarro - Partner, Tech/Digital, Clifford Chance
- Quoc-Viet Nguyen - Senior Associate, GovTech Campus Deutschland
- Karl Sydow - Head of Digital Health Committee, Pharma Deutschland
Locking down risk management strategies
Which regulations and guidance reference risk management for AI?
When to start thinking about and implementing risk management
How do you apply risk management principles for AI-enabled devices?
Case study: risk management in action
- Arun Mathew - Associate Director, Quality Systems (Risk Management), AbbVie
- What are EU AI regulatory sandboxes and what are they used for?
- What information do we have on how these will be established in
member states?
implementation of AI Regulatory Sandboxes - How do these compare to the UK Airlock and the AI/GenAI approaches explored there?
- What opportunities do sandboxes provide and how can they help shape
the future of device and diagnostic development?
What do manufacturers and notified bodies need to be aware of? - Can you develop AI without the use of sandboxes?
- Stephen Gilbert - Professor of Medical Device Regulatory Science, Else Kröner Fresenius Center for Digital Health, Technische Universität Dresden
- Alexander von Janowski - AI Certification Manager, TÜV AI.Lab
- James Dewar - Co-founder & CEO, Scarlet