Session

Overview: AI tools in radiation oncology are rapidly evolving, with growing clinical deployment across imaging, planning, and decision support. However, their use is now closely tied to compliance with increasingly strict regulatory frameworks such as the EU AI Act, EU Medical Device Regulation (MDR), as well as FDA guidelines further afield. This session will focus on the regulatory landscape for AI in radiotherapy, with emphasis on what clinical physicists need to know to ensure quality and compliance. Topics include risk classification, clinical evidence requirements, post-market surveillance, and the role of physicists in supporting conformity assessments. The goal is to provide attendees with a clear understanding of how QA intersects with legal and safety obligations, and what actions are needed to ensure that AI systems are fit-for-purpose in a regulated environment.