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”

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.

کلیدواژه ها:

Implantable Medical Devices ، Observational Data ، Real-World Evidence ، Federated Analytics ، Post-marketing Surveillance ، Regulatory Decision-Making