Development and initial field evaluation of the Imperial Regulatory Readiness Level framework for medical technologies

Objectives Medical-device innovation can progress through prototypes, commercial milestones and investor checkpoints while regulatory readiness remains undefined, inconsistently assessed or identified too late to shape development. We developed and initially evaluated the Imperial Regulatory Readiness Level (RRL) framework as a shared maturity model for regulatory progression across medical devices, in vitro diagnostics, software as a medical device and artificial intelligence-enabled medical technologies. Methods The nine-level RRL scale was developed by synthesising regulatory requirements, international standards, regulatory-science literature and translational experience from academic, small-sized and medium-sized enterprises (SMEs) and spinout medical-technology projects. Regulatory obligations were translated into a lifecycle scale from scoping to postmarket surveillance, vigilance and reporting. Initial usability and perceived utility were evaluated through a survey of UK MedTech SMEs and spinouts. Results RRL defines regulatory readiness as the extent to which a technology has identified, planned and generated the product definition, evidence, documentation, quality-system controls and lifecycle processes needed for regulatory progression in intended markets. The evaluated framework levels are: scoping; initial classification, regulatory and clinical strategy; intended use and in vitro performance claims; planning for regulatory compliance; regulatory-compliant development; initial regulatory submissions; quality management system certification and technical file preparation; market approval and postmarket surveillance, vigilance and reporting. Among 142 responses, 135 (95%) understood RRL without training, 128 (90%) could assign an approximate level and median helpfulness was 8/10 (IQR 7–9). Conclusions RRL offers a practical model to identify regulatory-readiness gaps early enough to effectively guide design, evidence generation and market-entry planning. This is framework development with usability and perceived utility evaluation, not independent validation of RRL-assignment accuracy or regulatory outcomes. Further studies should assess assessor consistency, agreement with independent expert review and effects on regulatory planning and translational progress.