Evidence integration and bridging methodologies for high-risk and innovative medical devices and

Background: High-risk and innovative medical devices, as well as Objective: To map methodologies for evidence integration and bridging studies in high-risk and innovative medical devices and Methods: A scoping review following Joanna Briggs Institute guidance was conducted using peer-reviewed and grey literature published from 2017 onward. Bibliographic databases, industry resources, and preprint platforms were searched. Included records addressed methods for comparing or integrating evidence for medical devices and Results: Nineteen studies were included. Identified methods included Bayesian evidence synthesis, adaptive trial designs, indirect comparisons, propensity score methods, real-world data integration, linked evidence frameworks, in silico approaches, and bridging studies. These methods support evaluation when conventional randomized clinical trials are limited or infeasible. Major challenges included evidence heterogeneity, bias, limited methodological standardization, and variable regulatory acceptance, particularly for Conclusion: Evidence integration methodologies are increasingly important in the evaluation of innovative medical devices and Systematic review registration: The scoping review was registered with the Open Science Framework (OSF). The Unique Identifier is 10.17605/OSF.IO/XNBSP, and the registration is publicly available at https://doi.org/10.17605/OSF.IO/XNBSP.