Presentation (CTI)

OBJECTIVES: The Regulation (EU) 2021/2282 on health technology assessment (HTA) establishes mandatory Joint Clinical Assessments (JCAs) for selected medicinal products and will extend to high‑risk medical devices and in vitro diagnostics in June 2026. While JCAs aim to harmonise clinical evidence evaluation, national reimbursement frameworks for devices and diagnostics remain highly heterogeneous. The applicability of the current JCA framework to medical devices was evaluated to assess the readiness of HTA bodies and identify methodological, operational, and system‑level challenges relevant to early implementation.
METHODS: A targeted review of EU HTA guidance and national HTA procedures for medical devices and diagnostics was conducted. Comparative analysis examined differences between medicines and devices in evidence generation, comparator selection, lifecycle evaluation, and national reimbursement pathways. Insights were synthesised to identify areas of convergence and divergence likely to influence national uptake of JCA outputs.
RESULTS: Three themes emerged. First, evidence heterogeneity and readiness gaps persist. HTA bodies recognise JCAs as an opportunity to strengthen evidence quality for devices, yet many remain cautious pending further guidance, and manufacturer preparedness for HTA‑appropriate evidence generation is variable. Second, substantial national variation in reimbursement frameworks may limit uniform uptake of JCA findings, as only a minority of countries operate formal HTA processes or structured mechanisms to manage uncertainty. Third, operational and methodological challenges, including misaligned timelines, uncertainty around harmonised PICO development, and the need for lifecycle‑based evidence, pose barriers for the first device JCAs.
CONCLUSIONS: JCAs for high‑risk medical devices and in vitro diagnostics represent a pivotal step toward EU‑level harmonisation. However, realising the Regulation’s objectives will require aligned timelines, strengthened national capacity, and clearer methodological standards tailored to device evidence. Early collaboration among regulators, HTA bodies, and manufacturers will be essential to ensure that JCA outputs can be effectively integrated into diverse national reimbursement systems.