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.
Journal article
Maad Rayan Publishing Company
2026-04-11T00:00:00+00:00
15
9557 - 9557
0