Presentation (CTI)

OBJECTIVES: The EU HTA Regulation mandates Joint Clinical Assessments (JCAs), requiring health technology developers (HTDs) to generate robust, harmonized evidence. While the JCA framework provides a consistent structure, medical devices (MDs) have unique characteristics, such as iterative developments, and user-dependent performance. This study compares submission templates for MDs and medicinal products (MPs), highlighting device-specific considerations to support HTDs with proactive evidence planning.
METHODS: A structured comparative framework was applied to JCA submission templates for MDs and MPs. The analysis focused on: (1) clinical evidence expectations; (2) PICO (patient, intervention, comparator, outcome) definitions and flexibility for device-specific pathways; and (3) literature review methodology and data identification standards. Differences were thematically analyzed to understand how MD-specific evidence considerations, such as iterative developments, learning curves, and user-dependent performance, are reflected in the templates. Findings were interpreted from the perspective of HTDs preparing submissions under the EU HTA Regulation.
RESULTS: JCA submission templates for MDs and MPs are largely similar, with a strong emphasis on comparative effectiveness. It mandates systematic literature reviews, PICO‑based evidence synthesis, and indirect effectiveness comparison. However, evidence evaluation for MDs presents unique challenges due to device-specific characteristics, which are not fully captured in the current templates. Addressing these differences is critical to ensure that the templates appropriately guide HTDs in generating relevant evidence. Streamlining the evidence evaluation process for MDs could also enable more efficient downstream decision-making, such as granting the national market access and reimbursement following positive JAC conclusions under the EU HTAR.
CONCLUSIONS: While JCA submission templates provide a consistent framework for MDs, the current design does not fully reflect device-specific considerations. Adapting templates to account for these characteristics can better support HTDs in generating robust, relevant evidence. Furthermore, streamlining both evidence evaluation and subsequent decision-making could facilitate more efficient national market access and reimbursement for MDs following positive JCA outcomes.