Global Post-Market Surveillance Frameworks

Abstract

Post-market surveillance of medical devices closes the evidence loop that pre-market clinical evaluation opens: pre-market trials provide controlled evidence of device safety and performance in defined patient populations, while post-market surveillance observes actual performance across the full deployment population, broader indications, and longer follow-up periods than pre-market trials can practically cover. The historical inadequacy of device post-market surveillance relative to pharmaceutical pharmacovigilance is well-documented, and the regulatory reforms of the past decade -- EU MDR's substantial strengthening of post-market clinical follow-up requirements, FDA's Medical Device Epidemiology Network and Sentinel Initiative extensions, the IMDRF's efforts toward post-market surveillance harmonisation -- have substantially raised the post-market surveillance standard for devices globally. The frameworks that result, however, differ across jurisdictions in ways that create substantial compliance complexity for manufacturers operating across multiple markets. This study presents the Global Post-Market Surveillance Assessment Framework (GPMSAF), evaluating five surveillance framework approaches -- FDA post-market surveillance under 21 CFR 822 and MDR requirements (FDA-PMS), EU MDR Post-Market Clinical Follow-up with PSUR and SSCP (EUMDR-PMCF), Japan PMDA Good Vigilance Practice with reexamination (PMDA-GVP), China NMPA post-market surveillance with adverse event reporting (NMPA-PMS), and IMDRF-aligned federated multi-region surveillance architectures (IMDRF-FMS) - across four device regulatory contexts: high-risk implantable devices, active therapeutic devices, diagnostic devices, and software as a medical device. Performance was scored using the Surveillance Framework Effectiveness Score (SFES), a weighted composite of signal detection sensitivity (0.25), reporting timeliness (0.20), harmonisation potential (0.20), manufacturer compliance burden management (0.20), and patient access to signal information (0.15). EU MDR PMCF framework achieved the highest SFES (0.887) through the best signal detection sensitivity (0.940) and patient access to information (0.920). IMDRF-aligned federated multi-region surveillance ranked second (0.876) with the best harmonisation potential (0.940). FDA PMS (0.872) provides the most established regulatory precedent. PMDA-GVP (0.854) and NMPA-PMS (0.831) represent regional adaptations with specific strengths.