AI medical device post-market surveillance regulations: consensus recommendations by the European Society of Radiology.
Authors
Affiliations (20)
Affiliations (20)
- Department of Medicine, Surgery, and Dentistry, University of Salerno, Baronissi, Italy. [email protected].
- European Society of Radiology (ESR), Vienna, Austria.
- Department of Radiology, University Medical Center, Mainz, Germany.
- Artificial Intelligence and Translational Imaging (ATI) Lab, Department of Radiology, School of Medicine, University of Crete, Heraklion, Crete, Greece.
- Department of Diagnostic and Interventional Neuroradiology, University Hospital Basel, Basel, Switzerland.
- Department of Pediatric Radiology, University Children's Hospital Basel, Basel, Switzerland.
- Local Health Unit-Aveiro Region; Faculty of Medicine, University of Coimbra, Coimbra, Portugal.
- Odisee UoAS, Brussels, Belgium.
- Radboud University Medical Center, Department of Radiology and Nuclear Medicine, Nijmegen, The Netherlands.
- Department of Diagnostic and Interventional Radiology, Medical Center-University of Freiburg, Freiburg, Germany.
- Medical Imaging Department and Biomedical Imaging Research Group at Hospital Universitario y Politécnico La Fe and Health Research Institute, Valencia, Spain.
- University of Medicine "Carol Davila", Bucharest, Romania.
- Department of Translational Research, University of Pisa, Pisa, Italy.
- Department of Diagnostic and Interventional Radiology, University Hospital of Tuebingen, Tuebingen, Germany.
- Radiology Department, Riga Stradins University, Riga, Latvia.
- Dipartimento di Scienze Radiologiche ed Ematologiche, Universita Cattolica del Sacro Cuore and Dipartimento Diagnostica per Immagini e Radioterapia Oncologica, Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
- Great Ormond Street Hospital, London, UK.
- University College London (UCL), London, UK.
- Department of Radiology, Netherlands Cancer Institute, Amsterdam, Netherlands.
- British Heart Foundation Centre for Research Excellence, University of Edinburgh, Edinburgh, United Kingdom.
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. CRITICAL RELEVANCE STATEMENT: Radiologists need to familiarize themselves with AIaMD EU regulations due to shared PMS responsibilities and current ambiguities. ESR recommendations aim to bridge this awareness gap, standardizing safe AI deployment and enhancing clinical feedback within medical imaging. KEY POINTS: Radiologists need a clear understanding of EU regulations for AIaMDs, as current laws lack imaging-specific guidance. There is a shared responsibility for AIaMD safety, with radiologists contributing to PMS and clinical feedback systems. The ESR provides crucial recommendations to standardize AI deployment and improve clinical feedback in imaging.