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
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.
Authors
- Conor Teljeur (ORCID: https://orcid.org/0000-0002-4494-1000)
- Susan Spillane (ORCID: https://orcid.org/0000-0002-2021-6664)
- Kieran Walsh (ORCID: https://orcid.org/0000-0002-4386-3012)
- Rasha A. Alshaikh (ORCID: https://orcid.org/0000-0003-2747-5084)
- Caitríona M. O’Driscoll (ORCID: https://orcid.org/0000-0002-6915-6201)
- Máirín Ryan (ORCID: https://orcid.org/0000-0002-3145-0878)
- Patricia Harrington (ORCID: https://orcid.org/0000-0003-1774-4420)
- Michelle O’Neill
Institutions
- University College Cork (IE)
- Health and Safety Authority (IE)
- Health Information and Quality Authority
Publication Details
- Journal
- Value in Health
- Published
- 2025-12-01
- DOI
- https://doi.org/10.1016/j.jval.2025.11.013
- Primary Topic
- Health Systems, Economic Evaluations, Quality of Life
- Type
- article
- Field-Weighted Citation Impact
- 0.00