Beyond CE Marking: The Need for Life-Cycle Health Technology Assessment of Medical Devices for Patient Safety and Health-System Value.

BACKGROUND/

objectivesMedical devices are essential to modern healthcare, but their adoption is often driven by regulatory conformity, clinical enthusiasm, procurement pressures and vendor-led innovation rather than systematic evaluation of comparative value. CE marking and related regulatory mechanisms are necessary for market access; however, they do not determine whether a device improves patient-related outcomes compared with existing alternatives, whether its benefits justify its total costs, or whether it can be implemented safely in routine care. This narrative review examines why medical devices require a dedicated life-cycle health technology assessment (HTA) approach and proposes an operational framework linking assessment to adoption, evidence generation, reassessment and disinvestment.

methodsA structured targeted search covered peer-reviewed literature and policy or institutional documents addressing HTA, medical devices, regulation, economic evaluation, real-world evidence, hospital-based HTA, procurement digital and AI-enabled devices, patient involvement and post-market reassessment.

resultsMedical devices differ from pharmaceuticals through user dependence, learning curves, procedure dependence, short product life cycles, incremental modification, heterogeneous comparators, limited randomized evidence and hidden life-cycle costs. These features create clinical, economic, organizational and implementation uncertainty after market entry. The proposed model specifies six linked phases: horizon scanning and early dialogue, pre-adoption appraisal, an explicit adoption decision, controlled implementation, real-world monitoring and scheduled or trigger-based reassessment leading to continuation, scale-up, restriction, or disinvestment. Practical constraints include fragmented data infrastructure, the cost of maintaining registries and residual confounding in real-world evidence.

conclusionsMedical device HTA should move beyond one-time pre-adoption assessment toward a decision-linked life-cycle model that integrates comparative value, patient and public involvement, procurement, implementation governance, real-world evidence, version monitoring, reassessment and disinvestment. This approach can support responsible innovation, patient safety, transparent procurement and sustainable health-system value.