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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
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 exem…
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