Reg Talk Medical Engineering: Compliance-by-Design of AI-based medical devices

The EU medical device market is highly regulated by sector-specific (e.g. the EU Medical Device Regulation) and cross-sector (e.g. the EU AI Act) legislation. As a result, manufacturers need to invest significant human and time resources in regulatory compliance before placing their products on the EU market. This problem can be solved by adopting a 'compliance by design' approach, which integrates regulatory requirements into the medical device design and development process from the outset. In addition to cost efficiency, key benefits include faster time-to-market, improved product quality and regulatory flexibility. 

In this event, the first presentation will deal with the most important legal and regulatory requirements for AI-based medical devices. As a solution, new processes and the adaptation of existing processes in the manufacturer's QMS will be presented, and finally, essential steps for a successful AI compliance project will be discussed. 

The second presentation focuses on the Notified Body perspective. Both common pitfalls in CE conformity assessment as well as procedures, challenges and timelines under the AI Act will be highlighted. 

We look forward to your participation!

Dr. Thorsten Prinz, VDE (Offenbach/Main)

Thomas Doerge, BSI (Frankfurt/Main)