Medical Devices and Real-World Data: Can We Improve Surveillance?; Comment on “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
Health Data Sciences, Botnar Research Centre, University of Oxford, Oxford, UK
2
Department of Medical Informatics, Erasmus MC University, Rotterdam, The Netherlands
Abstract
Hoogervorst et al systematically reviewed European cardiovascular and orthopaedic medical device registries to assess their preparedness for regulatory decision-making. The authors found high heterogeneity between data sources, limited transparency, and incomplete patient/procedure data, hindering cross-registry comparisons and regulatory reliability. Despite these limitations, registries remain essential for post-marketing surveillance, as exemplified by the case of “Metal on Metal” hip implants. In this commentary, we highlight emerging or ongoing initiatives focused on improving real-world evidence for medical devices, such as the UK’s Medical Devices Outcomes Registry (MDOR), which seeks to address current limitations by developing a centralised database with linkage to electronic health records (EHRs). Parallel initiatives, including Sentinel, Data Analytics and Real-World Interrogation Network (DARWIN EU®), National Evaluation System for Health Technology (NEST), and Guidance and Tools for Real-World Evidence Generation and Use for Decision-Making in Europe (GREG), seek to strengthen real-world evidence through common data models (CDMs) and federated analytics. Specifically, NEST and GREG focus on enhancing real-world data methods and guidelines for medical devices and drug-device combinations. Overall, all these initiatives represent major progress towards more robust and transparent systems for medical device surveillance.
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Alcalde-Herraiz, M. and Prieto-Alhambra, D. (2026). Medical Devices and Real-World Data: Can We Improve Surveillance?; Comment on “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”. International Journal of Health Policy and Management, (), -.
MLA
Alcalde-Herraiz, M. , and Prieto-Alhambra, D. . "Medical Devices and Real-World Data: Can We Improve Surveillance?; Comment on “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”", International Journal of Health Policy and Management, , , 2026, -.
HARVARD
Alcalde-Herraiz, M., Prieto-Alhambra, D. (2026). 'Medical Devices and Real-World Data: Can We Improve Surveillance?; Comment on “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”', International Journal of Health Policy and Management, (), pp. -.
CHICAGO
M. Alcalde-Herraiz and D. Prieto-Alhambra, "Medical Devices and Real-World Data: Can We Improve Surveillance?; Comment on “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”," International Journal of Health Policy and Management, (2026): -,
VANCOUVER
Alcalde-Herraiz, M., Prieto-Alhambra, D. Medical Devices and Real-World Data: Can We Improve Surveillance?; Comment on “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”. International Journal of Health Policy and Management, 2026; (): -.
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