AI medical device post-market surveillance regulations: consensus recommendations by the European Society of Radiology
Year: 2025
Type: article
Language: en
Topic: Artificial Intelligence in Healthcare and Education
Authors and affiliations:
raw_author_name: Renato Cuocolo
raw_affiliation_strings: Department of Medicine, Surgery, and Dentistry, University of Salerno, Baronissi, Italy. rcuocolo@unisa.it
Department of Medicine, Surgery, and Dentistry, University of Salerno, Baronissi, Italy
raw_author_name: Diana Bernardini
raw_affiliation_strings: European Society of Radiology (ESR), Vienna, Austria
raw_author_name: Daniel Pinto dos Santos
raw_affiliation_strings: Department of Radiology, University Medical Center, Mainz, Germany
raw_author_name: Michail E. Klontzas
raw_affiliation_strings: Artificial Intelligence and Translational Imaging (ATI) Lab, Department of Radiology, School of Medicine, University of Crete, Heraklion, Crete, Greece
raw_author_name: Tugba Akinci D’Antonoli
raw_affiliation_strings: Department of Diagnostic and Interventional Neuroradiology, University Hospital Basel, Basel, Switzerland
Department of Pediatric Radiology, University Children’s Hospital Basel, Basel, Switzerland
Department of Pediatric Radiology, University Children's Hospital Basel, Basel, Switzerland
raw_author_name: Luís Curvo Semedo
raw_affiliation_strings: Local Health Unit-Aveiro Region; Faculty of Medicine, University of Coimbra, Coimbra, Portugal
Faculty of Medicine, University of Coimbra, Coimbra, Portugal
Local Health Unit—Aveiro Region
raw_author_name: Robin Decoster
raw_affiliation_strings: Odisee UoAS, Brussels, Belgium
raw_author_name: Merel Huisman
raw_affiliation_strings: Radboud University Medical Center, Department of Radiology and Nuclear Medicine, Nijmegen, The Netherlands
raw_author_name: Elmar Kotter
raw_affiliation_strings: Department of Diagnostic and Interventional Radiology, Medical Center-University of Freiburg, Freiburg, Germany
Department of Diagnostic and Interventional Radiology, Medical Center—University of Freiburg, Freiburg, Germany
raw_author_name: Luis Martí-Bonmatí
raw_affiliation_strings: Medical Imaging Department and Biomedical Imaging Research Group at Hospital Universitario y Politécnico La Fe and Health Research Institute, Valencia, Spain
raw_author_name: Costin Minoiu
raw_affiliation_strings: University of Medicine "Carol Davila", Bucharest, Romania
raw_author_name: Emanuele Neri
raw_affiliation_strings: Department of Translational Research, University of Pisa, Pisa, Italy
raw_author_name: Konstantin Nikolaou
raw_affiliation_strings: Department of Diagnostic and Interventional Radiology, University Hospital of Tuebingen, Tuebingen, Germany
raw_author_name: Maija Radzina
raw_affiliation_strings: Radiology Department, Riga Stradins University, Riga, Latvia
raw_author_name: Evis Sala
raw_affiliation_strings: 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
raw_author_name: Susan C. Shelmerdine
raw_affiliation_strings: Great Ormond Street Hospital, London, UK
University College London (UCL), London, UK
raw_author_name: Laurens Topff
raw_affiliation_strings: Department of Radiology, Netherlands Cancer Institute, Amsterdam, Netherlands
raw_author_name: Michelle C. Williams
raw_affiliation_strings: British Heart Foundation Centre for Research Excellence, University of Edinburgh, Edinburgh, United Kingdom
raw_author_name: European Society of Radiology (ESR)