Kerman University of Medical Sciences International Journal of Health Policy and Management 2322-5939 12 Issue 1 2023 12 01 Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review 1 11 4470 10.34172/ijhpm.2023.7648 EN Lotje A. Hoogervorst Department of Orthopaedics, Leiden University Medical Center, Leiden, The Netherlands Department of Biomedical Data Sciences & Medical Decision Making, Leiden University Medical Center, Leiden, The Netherlands 0000-0001-5343-6965 Timon H. Geurkink Department of Orthopaedics, Leiden University Medical Center, Leiden, The Netherlands 0000-0003-4290-6161 Anne Lübbeke Division of Orthopaedic Surgery and Traumatology, Geneva University Hospitals and University of Geneva, Geneva, Switzerland Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK Sergio Buccheri Department of Cardiology, Uppsala University, Uppsala, Sweden 0000-0002-7767-3073 Jan W. Schoones Directorate of Research Policy (Formerly: Walaeus Library), Leiden University Medical Center, Leiden, The Netherlands 0000-0003-1120-4781 Marina Torre Scientific Secretariat of the Presidency, Istituto Superiore di Sanità, Rome, Italy 0000-0003-3851-187X Paola Laricchiuta Scientific Secretariat of the Presidency, Istituto Superiore di Sanità, Rome, Italy 0000-0001-6892-7185 Paul Piscoi Health Technology Unit B6, Directorate General for Health (DG SANTE), European Commission, Brussels, Belgium Alma B. Pedersen Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark Department of Clinical Medicine, Aarhus University, Aarhus, Denmark 0000-0002-3288-9401 Chris P. Gale Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK Leeds Institute for Data analytics, University of Leeds, Leeds, UK Department of Cardiology, Leeds Teaching Hospitals NHS Trust, Leeds, UK 0000-0003-4732-382X James A. Smith Botnar Research Centre and Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK National Institute for Health Research Oxford Biomedical Research Centre, John Radcliffe Hospital, Oxford, UK Aldo P. Maggioni Centro Studi ANMCO, Via Alfonso la Marmora, Florence, Italy 0000-0003-2764-6779 Stefan James Department of Cardiology, Uppsala University, Uppsala, Sweden Department of Medical Science, Uppsala University, Uppsala, Sweden Clinical Research Center, Uppsala University, Uppsala, Sweden 0000-0003-4413-9736 Alan G. Fraser Department of Cardiology, University Hospital of Wales, Cardiff, UK Rob G.H.H. Nelissen Department of Orthopaedics, Leiden University Medical Center, Leiden, The Netherlands 0000-0003-1228-4162 Perla J. Marang-van De Mheen Department of Biomedical Data Sciences & Medical Decision Making, Leiden University Medical Center, Leiden, The Netherlands 0000-0003-1439-0989 Journal Article 2022 08 24 Background The European Union Medical Device Regulation (MDR) requires manufacturers to undertake post-market clinical follow-up (PMCF) to assess the safety and performance of their devices following approval and Conformité Européenne (CE) marking. The quality and reliability of device registries for this Regulation have not been reported. As part of the Coordinating Research and Evidence for Medical Devices (CORE-MD) project, we identified and reviewed European cardiovascular and orthopaedic registries to assess their structures, methods, and suitability as data sources for regulatory purposes.Methods Regional, national and multi-country European cardiovascular (coronary stents and valve repair/replacement) and orthopaedic (hip/knee prostheses) registries were identified using a systematic literature search. Annual reports, peer-reviewed publications, and websites were reviewed to extract publicly available information for 33 items related to structure and methodology in six domains and also for reported outcomes.Results Of the 20 cardiovascular and 26 orthopaedic registries fulfilling eligibility criteria, a median of 33% (IQR: 14%-71%) items for cardiovascular and 60% (IQR: 28%-100%) items for orthopaedic registries were reported, with large variation across domains. For instance, no cardiovascular and 16 (62%) orthopaedic registries reported patient/procedure-level completeness. No cardiovascular and 5 (19%) orthopaedic registries reported outlier performances of devices, but each with a different outlier definition. There was large heterogeneity in reporting on items, outcomes, definitions of outcomes, and follow-up durations.Conclusion European cardiovascular and orthopaedic device registries could improve their potential as data sources for regulatory purposes by reaching consensus on standardised reporting of structural and methodological characteristics to judge the quality of the evidence as well as outcomes. https://www.ijhpm.com/article_4470_a3ab4ff8fa4deed2e3bae3a5077675f0.pdf