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 to AI components. This regulatory ambiguity underscores a critical need for clarified guidelines concerning "high-risk" AI classification and best practices for safe deployment within the radiological workflow. Legal responsibility for AIaMD Post-Market Surveillance (PMS) primarily rests with softwa

SUBMITTER: Cuocolo R 

PROVIDER: S-EPMC12701188 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature