Clinical Investigation of Health Technologies: A Scoping Review of Evaluation Methods
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The aim of this scoping review was to synthesize and map recommended evaluation methods for the clinical investigation of health technologies. A database search was conducted in January 2025 in the Scopus, Ovid MEDLINE, and CINAHL databases, and grey literature was searched in the Mednar database. Publications from 2015–2024 were included if they described the clinical investigation of health technologies at various maturity levels, as assessed using the Technology Readiness Level (TRL) framework. Nine studies were included in the review. Recommended evaluation methods varied across different TRLs, with considerable overlap observed between evaluation domains. In addition, these methods exhibited an evolutionary progression, becoming increasingly rigorous and incorporating broader contextual and social considerations as technological maturity advanced. At TRLs 5–6, clinical investigations focused on efficacy; at TRLs 7–8, on effectiveness and clinical validity; and at the highest maturity level, on implementation and clinical utility. Notably, evaluation methods were not recommended by device risk class. The clinical investigations of health technologies remains fragmented, and no consistent approach has been established. The application of the TRL framework provided a novel and structured approach to map evaluation methods according to the stage of maturity. There is a need for harmonized evaluation frameworks that support clinical investigations in line with EU regulations.