Lotje A. Hoogervorst - Department of Orthopaedics, Leiden University Medical Center, Leiden, The Netherlands
Timon H. Geurkink - Department of Orthopaedics, Leiden University Medical Center, Leiden, The Netherlands
Anne Lübbeke - Division of Orthopaedic Surgery and Traumatology, Geneva University Hospitals and University of Geneva, Geneva, Switzerland
Sergio Buccheri - Department of Cardiology, Uppsala University, Uppsala, Sweden
Jan W. Schoones - Directorate of Research Policy (Formerly: Walaeus Library), Leiden University Medical Center, Leiden, The Netherlands
Marina Torre - Scientific Secretariat of the Presidency, Istituto Superiore di Sanità, Rome, Italy
Paola Laricchiuta - Scientific Secretariat of the Presidency, Istituto Superiore di Sanità, Rome, Italy
Paul Piscoi - Health Technology Unit B۶, Directorate General for Health (DG SANTE), European Commission, Brussels, Belgium
Alma B. Pedersen - Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark
Chris P. Gale - Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK
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
Aldo P. Maggioni - Centro Studi ANMCO, Via Alfonso la Marmora, Florence, Italy
Stefan James - Department of Cardiology, Uppsala University, Uppsala, Sweden
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
Perla J. Marang-van de Mheen - Department of Biomedical Data Sciences & Medical Decision Making, Leiden University Medical Center, Leiden, The Netherlands

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 ۳۳ items related to structure and methodology in six domains and also for reported outcomes.Results  Of the ۲۰ cardiovascular and ۲۶ orthopaedic registries fulfilling eligibility criteria, a median of ۳۳% (IQR: ۱۴%-۷۱%) items for cardiovascular and ۶۰% (IQR: ۲۸%-۱۰۰%) items for orthopaedic registries were reported, with large variation across domains. For instance, no cardiovascular and ۱۶ (۶۲%) orthopaedic registries reported patient/procedure-level completeness. No cardiovascular and ۵ (۱۹%) 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.

Medical Device Registries, Cardiovascular, Orthopaedic