Recommended methodologies for clinical investigations of high-risk medical devices-Conclusions from the European Union CORE-MD Project. - Fraser AG; Buccheri S; Byrne RA; Kjaersgaard-Andersen P; James S; Jüni P; Bally L; Bulbulia R; Koletzko BV; Landray MJ; Louati C; Lübbeke A; et al. (The Lancet regional health. Europe, 2025)