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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.
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
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  Data: <searchLink fieldCode="AU" term="%22Fraser+AG%22">Fraser AG</searchLink>; 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.<br /><searchLink fieldCode="AU" term="%22Buccheri+S%22">Buccheri S</searchLink>; Department of Medical Sciences, Uppsala University Hospital, and Uppsala Clinical Research Center, Uppsala Science Park, Dag Hammarskjölds Väg 38, Uppsala SE-751 85, Sweden.<br /><searchLink fieldCode="AU" term="%22Byrne+RA%22">Byrne RA</searchLink>; Cardiovascular Research Institute (CVRI) Dublin and Department of Cardiology, Mater Private Network, Dublin, Ireland.; School of Pharmacy and Biomolecular Sciences, RCSI University, Dublin, Ireland.<br /><searchLink fieldCode="AU" term="%22Kjaersgaard-Andersen+P%22">Kjaersgaard-Andersen P</searchLink>; Department of Orthopaedic Surgery, Vejle Hospital, South Danish University, Vejle 7100, Denmark.<br /><searchLink fieldCode="AU" term="%22James+S%22">James S</searchLink>; Department of Medical Sciences, Uppsala University Hospital, and Uppsala Clinical Research Center, Uppsala Science Park, Dag Hammarskjölds Väg 38, Uppsala SE-751 85, Sweden.<br /><searchLink fieldCode="AU" term="%22Jüni+P%22">Jüni P</searchLink>; Clinical Trial Service Unit, Nuffield Department of Population Health, University of Oxford, Oxford OX3 7LF, UK.<br /><searchLink fieldCode="AU" term="%22Bally+L%22">Bally L</searchLink>; Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital and University of Bern, Freiburgstrasse 15, Bern 3010, Switzerland.<br /><searchLink fieldCode="AU" term="%22Bulbulia+R%22">Bulbulia R</searchLink>; Clinical Trial Service Unit, Nuffield Department of Population Health, University of Oxford, Oxford OX3 7LF, UK.<br /><searchLink fieldCode="AU" term="%22Koletzko+BV%22">Koletzko BV</searchLink>; 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.<br /><searchLink fieldCode="AU" term="%22Landray+MJ%22">Landray MJ</searchLink>; Clinical Trial Service Unit, Nuffield Department of Population Health, University of Oxford, Oxford OX3 7LF, UK.<br /><searchLink fieldCode="AU" term="%22Louati+C%22">Louati C</searchLink>; European Patients Forum, Chaussée d'Etterbeek 180, Brussels 1040, Belgium.<br /><searchLink fieldCode="AU" term="%22Lübbeke+A%22">Lübbeke A</searchLink>; 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.<br /><searchLink fieldCode="AU" term="%22Marang-van+de+Mheen+PJ%22">Marang-van de Mheen PJ</searchLink>; Safety & Security Science, Delft University of Technology, Jaffalaan 5, 2628 BX, Delft, the Netherlands.<br /><searchLink fieldCode="AU" term="%22McCulloch+P%22">McCulloch P</searchLink>; Nuffield Department of Surgical Sciences, University of Oxford, John Radcliffe Hospital, Headington, Oxford OX3 9DU, UK.<br /><searchLink fieldCode="AU" term="%22Patro-Golab+B%22">Patro-Golab B</searchLink>; 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.<br /><searchLink fieldCode="AU" term="%22Rademakers+FE%22">Rademakers FE</searchLink>; Biomedical Sciences, KU Leuven, Herestraat 49, Leuven 3000, Belgium.<br /><searchLink fieldCode="AU" term="%22Schnell-Inderst+P%22">Schnell-Inderst P</searchLink>; 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.<br /><searchLink fieldCode="AU" term="%22Siontis+GCM%22">Siontis GCM</searchLink>; Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland.<br /><searchLink fieldCode="AU" term="%22Torre+M%22">Torre M</searchLink>; Istituto Superiore di Sanità, Viale Regina Elena, 299 00161, Roma, Italy.<br /><searchLink fieldCode="AU" term="%22Wild+C%22">Wild C</searchLink>; Austrian Institute of Health Technology Assessment, Garnisongasse 7/20, Vienna 1090, Austria.<br /><searchLink fieldCode="AU" term="%22Zeisl+Y%22">Zeisl Y</searchLink>; European Patients Forum, Chaussée d'Etterbeek 180, Brussels 1040, Belgium.<br /><searchLink fieldCode="AU" term="%22Melvin+T%22">Melvin T</searchLink>; Institute for Clinical Trials, College of Medicine, Nursing and Health Sciences, University of Galway, Ireland.<br /><searchLink fieldCode="AU" term="%22Nelissen+RGHH%22">Nelissen RGHH</searchLink>; Department of Orthopaedic Surgery, Leiden University Medical Center, Leiden 2300 RC, the Netherlands.
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  Data: <searchLink fieldCode="JN" term="%22101777707%22">The Lancet regional health. Europe</searchLink> [Lancet Reg Health Eur] 2025 Sep 15; Vol. 58, pp. 101460. <i>Date of Electronic Publication: </i>2025 Sep 15 (<i>Print Publication: </i>2025).
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22[Oxford]%22">[Oxford] </searchLink><i>Country of Publication: </i>England <i>NLM ID: </i>101777707 <i>Publication Model: </i>eCollection <i>Cited Medium: </i>Internet <i>ISSN: </i>2666-7762 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2226667762%22">26667762 </searchLink><i>NLM ISO Abbreviation: </i>Lancet Reg Health Eur <i>Subsets: </i>PubMed not MEDLINE
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