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

    Renato Cuocolo, Diana Bernardini, Daniel Pinto Dos Santos, Michail E Klontzas, Tugba Akinci D'Antonoli, Lu�s Curvo Semedo, Robin Decoster, Merel Huisman, Elmar Kotter, Luis Mart�-Bonmat�, Costin Minoiu, Emanuele Neri, Konstantin Nikolaou, Maija Radzina, Evis Sala, Susan C Shelmerdine, Laurens Topff, Michelle C Williams; European Society of Radiology (ESR)
    Insights Imaging. 2025 Dec 12;16(1):275. doi: 10.1186/s13244-025-02146-8.

    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 software providers, yet radiologists are expected to contribute to the ongoing monitoring of safety and performance. Recognizing the need to raise awareness and provide practical guidance, the European Society of Radiology (ESR) eHealth and Informatics Subcommittee, supported by the ESR AI Working Group, conducted a modified Delphi procedure involving 16 domain experts (of which 14 acted as panelists) to establish a set of shared recommendations. These aim to establish essential practices for AIaMD PMS and post-market clinical feedback (PMCF), as stipulated by the MDR and partially updated by the AI Act. This paper also provides an overview of relevant regulations to enhance awareness among all stakeholders, particularly deployers (e.g., radiologists) and providers (e.g., vendors). These recommendations represent a foundational step towards improving consistency in AIaMD deployment, providing a critical reference standard for physicians navigating the unique challenges posed by these novel technologies.