Advancing Public Health Through Internationally Coordinated Medical Device Registries; 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”

This commentary draws on findings from Hoogervorst et al۱ to underscore the urgent need for internationally coordinated medical device registries, addressing the fragmentation and inconsistency currently limiting their utility in Europe. It advocates for registries governed by academic specialty societies to ensure scientific integrity, transparency, and clinical relevance. Such registries can significantly enhance post-market surveillance, support regulatory compliance and accelerate real-world evidence (RWE) generation. The importance of standardized data collection, regular outcome reporting, and contributor recognition to foster engagement and improve data quality is highlighted. By complementing randomized controlled trials (RCTs), registries can detect rare adverse events, inform clinical guidelines and drive innovation. Actionable recommendations for governance, data harmonization and interoperability are given, emphasizing that now is the time for academic societies to lead this transformation for the benefit of patients and healthcare systems globally.

کلیدواژه ها:

Medical Device Registries ، Real-World Evidence (RWE) ، International Coordination ، Academic Societies ، Post-market Surveillance