Recommended methodologies for clinical investigations of high-risk medical devices-Conclusions from the European Union CORE-MD Project.
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| Title: | Recommended methodologies for clinical investigations of high-risk medical devices-Conclusions from the European Union CORE-MD Project. |
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| Authors: | Fraser AG; Department of Cardiology, University Hospital of Wales, and School of Medicine, Cardiff University, Heath Park, Cardiff CF14 4XW, UK.; Cardiovascular Imaging and Dynamics, KU Leuven, Leuven, Belgium., Buccheri S; Department of Medical Sciences, Uppsala University Hospital, and Uppsala Clinical Research Center, Uppsala Science Park, Dag Hammarskjölds Väg 38, Uppsala SE-751 85, Sweden., Byrne RA; Cardiovascular Research Institute (CVRI) Dublin and Department of Cardiology, Mater Private Network, Dublin, Ireland.; School of Pharmacy and Biomolecular Sciences, RCSI University, Dublin, Ireland., Kjaersgaard-Andersen P; Department of Orthopaedic Surgery, Vejle Hospital, South Danish University, Vejle 7100, Denmark., James S; Department of Medical Sciences, Uppsala University Hospital, and Uppsala Clinical Research Center, Uppsala Science Park, Dag Hammarskjölds Väg 38, Uppsala SE-751 85, Sweden., Jüni P; Clinical Trial Service Unit, Nuffield Department of Population Health, University of Oxford, Oxford OX3 7LF, UK., Bally L; Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital and University of Bern, Freiburgstrasse 15, Bern 3010, Switzerland., Bulbulia R; Clinical Trial Service Unit, Nuffield Department of Population Health, University of Oxford, Oxford OX3 7LF, UK., Koletzko BV; Department of Paediatrics, Dr. von Hauner Children's Hospital, LMU University Hospital, and German Center for Child and Adolescent Health, Lindwurmstr. 4, Munich 80337, Germany., Landray MJ; Clinical Trial Service Unit, Nuffield Department of Population Health, University of Oxford, Oxford OX3 7LF, UK., Louati C; European Patients Forum, Chaussée d'Etterbeek 180, Brussels 1040, Belgium., Lübbeke A; Division of Orthopaedics & Trauma Surgery, Geneva University Hospitals and University of Geneva, Switzerland.; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK., Marang-van de Mheen PJ; Safety & Security Science, Delft University of Technology, Jaffalaan 5, 2628 BX, Delft, the Netherlands., McCulloch P; Nuffield Department of Surgical Sciences, University of Oxford, John Radcliffe Hospital, Headington, Oxford OX3 9DU, UK., Patro-Golab B; Department of Paediatrics, Dr. von Hauner Children's Hospital, LMU University Hospital, and German Center for Child and Adolescent Health, Lindwurmstr. 4, Munich 80337, Germany., Rademakers FE; Biomedical Sciences, KU Leuven, Herestraat 49, Leuven 3000, Belgium., Schnell-Inderst P; Institute of Public Health, Medical Decision Making and Health Technology Assessment, UMIT TIROL - University for Health Sciences and Technology, Eduard-Wallnoefer-Zentrum 1, Hall in Tirol 6060, Austria., Siontis GCM; Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland., Torre M; Istituto Superiore di Sanità, Viale Regina Elena, 299 00161, Roma, Italy., Wild C; Austrian Institute of Health Technology Assessment, Garnisongasse 7/20, Vienna 1090, Austria., Zeisl Y; European Patients Forum, Chaussée d'Etterbeek 180, Brussels 1040, Belgium., Melvin T; Institute for Clinical Trials, College of Medicine, Nursing and Health Sciences, University of Galway, Ireland., Nelissen RGHH; Department of Orthopaedic Surgery, Leiden University Medical Center, Leiden 2300 RC, the Netherlands. |
| Corporate Authors: | CORE–MD Consortium |
| Source: | The Lancet regional health. Europe [Lancet Reg Health Eur] 2025 Sep 15; Vol. 58, pp. 101460. Date of Electronic Publication: 2025 Sep 15 (Print Publication: 2025). |
| Publication Type: | Journal Article; Review |
| Journal Info: | Publisher: [Oxford] Country of Publication: England NLM ID: 101777707 Publication Model: eCollection Cited Medium: Internet ISSN: 2666-7762 (Electronic) Linking ISSN: 26667762 NLM ISO Abbreviation: Lancet Reg Health Eur Subsets: PubMed not MEDLINE |
| Database: | MEDLINE Ultimate |
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