AI medical device post-market surveillance regulations: consensus recommendations by the European Society of Radiology.

Abstract

The increasing integration of artificial intelligence as medical devices (AIaMDs) within diagnostic imaging necessitates a robust understanding of associated regulatory frameworks among clinical practitioners. Despite the growing commercial availability and adoption of AIaMD, a significant awareness gap persists among radiologists regarding pertinent European Union regulations, including the Medical Device Regulation (MDR) and the novel EU AI Act, both of which lack explicit provisions tailored