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Notes and references:
1. 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, Marang-van de Mheen PJ, McCulloch P, Patro-Golab B, Rademakers FE, Schnell-Inderst P, Siontis GCM, Torre M, Wild C, Zeisl Y, Melvin T, Nelissen RGHH; on behalf of the CORE–MD consortium. Recommended methodologies for clinical investigations of high-risk medical devices – Conclusions from the European Union CORE–MD Project. The Lancet Regional Health Europe. 2025. (E-pub] doi: 10.1016/j.lanepe.2025.101460 https://www.thelancet.com/journals/LANEPE/article/PIIS2666-7762(25)00252-2/fulltext
The recommendations are published in The Lancet Regional Health – Europe: Fraser AG, et al., on behalf of the CORE-MD consortium. Recommended methodologies for clinical investigations of high-risk medical devices – Conclusions from the EU CORE-MD Project.The CORE-MD project was funded by the European Union’s Horizon 2020 Research and Innovation programme (Grant agreement No. 965246). https://www.core-md.eu/
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