The Early Experiences of Health Technology Assessment Bodies in the Implementation of the European Union Health Technology Assessment Regulation for High-Risk Medical Devices: A Qualitative Study

Objectives: The EU Health Technology Assessment Regulation (HTAR) introduces joint clinical assessments (JCAs) to harmonize clinical evidence evaluation across Member States. JCAs are commencing in 2026 for high-risk medical devices (MD) and in vitro diagnostics (IVD), but little is known about how national health technology assessment (HTA) bodies are preparing for implementation. This study aims to explore how selected European Union (EU)/European Economic Area HTA bodies are planning for JCAs integration and HTAR implementation for high-risk MD/IVD. Methods: Semistructured interviews were conducted with 15 participants from 11 different HTA bodies across 11 EU/European Economic Area Member States. Interviews were recorded and transcribed verbatim before being anonymized and coded using NVivo Software. Data were analyzed using thematic analysis. Results: All participants recognized JCAs as a potential tool for improving evidence quality for high-risk devices and highlighted their willingness to use JCA-generated evidence in their clinical assessment. Some HTA bodies have initiated procedural or legislative adaptations; however, many remain in an observational position, waiting for further implementation documents. Key opportunities identified included work sharing, improved evidence standards, and capacity building, particularly in smaller HTA systems that might not have access to high-quality assessments without JCAs. However, substantial challenges were reported, including regulatory uncertainty, timing misalignments, and limited manufacturer preparedness for JCA evidence demands. Conclusions: HTAR is viewed as an opportunity to strengthen HTA practices for high-risk MD/IVD. However, realizing its goals will require further collaboration, alignment of procedural timelines, and investment in national capacity. Further studies are needed after full HTAR implementation for high-risk MD/IVD to capture ongoing experiences.