MAPPING CURRENT DECISION-MAKING PATHWAYS AND REIMBURSEMENT PROCESSES FOR HIGH-RISK MEDICAL DEVICES IN EU/EEA MEMBER STATES AND THE UK: A SCOPING REVIEW

Objectives: The reimbursement of, and subsequent patient access to, high-risk medical devices (MD) and in vitro diagnostics (IVD) across Europe often vary. The Health Technology Assessment Regulation (HTAR) aims to standardize clinical evaluations through Joint Clinical Assessments. Still, national differences in reimbursement frameworks and evidence integration for MD/IVD may impede the realization of HTAR’s expected benefits. This review aims to map existing reimbursement frameworks for high-risk MD/IVD, identify key oversight structures, and evaluate the use of comparative effectiveness and safety evidence in reimbursement decisions across EU/EEA/UK. Methods: A scoping review was conducted according to the registered protocol (osf.io/65bdk) and was reported following the PRISMA-ScR guidelines. Results were validated through direct engagement with national organizations. Results: Reimbursement frameworks across EU/EEA/UK for MD/IVD vary significantly. Of the 34 countries reviewed, 23 incorporate HTA for MD/IVD reimbursement decisions; of these, only 11 countries have a formal HTA process as part of reimbursement pathways. Eight countries have structured mechanisms to address safety and effectiveness evidence uncertainty. Furthermore, 12 countries have primarily centralized processes, while six rely on regional or local decision-making. Conclusion: This review highlights the variations in how countries integrate HTA into reimbursement frameworks for MD/IVD, how the national decisions are implemented and how the evidence uncertainty is assessed. Some countries have a well-established reimbursement framework with formal HTA components, whereas others rely on ad-hoc HTA processes. Understanding these differences can help optimize the use of HTAR-generated evidence. Further research is needed to capture ongoing reforms in response to the HTAR.