EU MDR & AI Act: Bringing AI-Enabled Devices to Europe

Watch the webinar recording

In recent years, the incorporation of AI and Machine Learning (AI/ML) into medical devices has increased rapidly across startups and large MedTech companies. At the same time, Europe’s regulatory requirements have also undergone significant changes. 

Join TÜV SÜD’s Global Portfolio Manager, Malte Knowles Schmidt, for an expert-led on-demand webinar to learn about the general requirements for AI/ML-enabled medical devices, key timelines, and how to achieve compliance for entry into the European market. 

This on-demand webinar will also cover the current regulatory environment for AI/ML-enabled medical devices under the EU Medical Device Regulation (MDR) and provide an outlook on how the EU AI Act will change the status quo. 

Key Takeaways: 

• AI Product assessment under EU MDR 
• General requirements for devices incorporating Artificial Intelligence and Machine Learning (AI/ML). 
• EU AI Act Timeline and relevant Players 
• Conformity Assessment under the EU AI Act  
  Practical steps to achieve compliance and market entry. 

Who Should watch the on demand webinar: 

• Small and medium-sized MedTech companies, startups, and innovators developing AI/ML-enabled medical devices. 
• Regulatory professionals seeking clarity on EU MDR & AI Act requirements. 
• Product developers and compliance teams preparing for European market entry. 

About the expert: 

Malte Knowles Schmidt 
Global Portfolio Manager SaMD, AI and Cybersecurity, TÜV SÜD 

Malte has worked in various roles across the healthcare industry, working with implantable cardiac devices and later moving into user-centric SaMD development within corporate venture labs. Since April 2024, he has been with TÜV SÜD, shaping the service portfolio for SaMD, AI, and Cybersecurity, ensuring these offerings are guided by real customer needs and deliver practical value to manufacturers.