(AI-generated summary)
In this A&A session by Ismail Gögenur, Carsten Utoft Niemann and Christoffer E. Hother,  the impact of AI models on medical device regulation (MDR) is discussed, and whether adaptive AI requires more frequent approval.

The EPIC system's lack of MDR is discussed, and how the well-known use of paracetamol challenges the need for model explainability. The importance of clinician involvement in modeling is highlighted, and research and understanding of AI are crucial for both reliability and robustness.

The debate clarifies how practice changes are implemented without evidence from randomized trials and the desire for a real-time monitoring model.