Recommended methodologies for clinical investigations of high-risk medical devices—Conclusions from the European Union CORE–MD Project

Alan G. Fraser, Sergio Buccheri, Robert A. Byrne, Per Kjærsgaard‐Andersen, Stefan James, Peter Jüni, Lia Bally, Richard Bulbulia, Berthold Koletzko, Martin Landray, Claudia Louati, Anne Lübbeke, Perla J. Marang‐van de Mheen, Peter McCulloch, Bernadeta Patro-Gołąb, Frank Rademakers, Petra Schnell‐Inderst, George C.M. Siontis, Marina Torre, Claudia Wild, Yasemin Zeisl, Tom Melvin, Rob G. H. H. Nelissen, Piotr Szymański, Chris P Gale, Aldo Maggioni, Chris Wilkinson, Fábio Santos Santana, Valentina Tageo, Jean-Baptiste Rouffet, Adrian Ott, Elizabeth Macintyre, Marieke Meijer, Loredana Simulescu, Kathrin Guerlich, Hannes Jarke, Valentina Strammiello, Lotje A. Hoogervorst, Ewout W. Steyerberg, Jasper W.A. van Egeraat, Alma B Pedersen, William Plath, Baptiste Vasey, Marion Mafham, Louise Bowman, James Smith, Christophe Combescure, Christophe Baréa, Jonas Oldgren, Laurna McGovern, J J Coughlan, Rory Durand, Stephan Windecker, Andrè Frenk, Bernadette Coles, Arjola Bano, Juri Künzler, Faina Wehrli, Lum Kastrati, Markus Laimer, Elisabetta Biasin, Erik Kamenjašević, J. Gary Meszaros, Isabelle Huys, Pascal Borry, Ursula Rochau, Tanja Planinschitz, Uwe Siebert, David Epstein, John Eric Chaplin, Ola Rolfson, Enrico G. Caiani, Yijun Ren, Donal B O’Connor, Gearóid McGauran, G. A. O’Connor, Niall MacAleenan, Sanjeev Yoganathan, Jan Szulc, Robert E. Geertsma, Jantine W.P.M. van Baal, Paola Laricchiuta, E. Carrani, Stefania Ceccarelli, Enrico Ciminello, Sabine Ettinger, Juan Antonio Blasco‐Amaro, Agnieszka Dobrzynska, Jesús Aranda, Juan Carlos Rejón-Parrilla, Françoise Schlemmer, Sabina Hoekstra, Richard Holborow, Marianna Mastroroberto, Erman Melikyan, Alexey Shiryaev, Christoph Ziskoven (2025). Recommended methodologies for clinical investigations of high-risk medical devices—Conclusions from the European Union CORE–MD Project. , 58, DOI: https://doi.org/10.1016/j.lanepe.2025.101460.