The Early Experiences Of Health Technology Assessment Bodies In The Implementation Of The EU HTA Regulation (HTAR) For High-Risk Medical Devices: A Qualitative Study

The plans for implementing the EU HTA Regulation (HTAR) for high-risk medical devices (MD) and in vitro diagnostics (IVD) vary significantly across EU/EEA member states. This study addresses a key evidence gap by exploring through semi-structured interviews, how national HTA bodies across 11 countries are preparing to implement the evidence from HTAR for high-risk MD/IVD.

Date of publication: 06 Dec 2025
Authors: Rasha A. Alshaikh, Kieran A. Walsh, Susan Spillane, Patricia Harrington, Michelle O'Neill, Conor Teljeur, Máirín Ryan & Caitriona M. O'Driscoll
Journal: Value in Health
Digital object identifier: 10.1016/j.jval.2025.11.013
Type of output: Original Research
Suggested Citation:

Alshaikh RA, Walsh KA, Spillane S, Harrington P, O'Neill M, Teljeur C, Ryan M, O'Driscoll CM. The Early Experiences Of Health Technology Assessment Bodies In The Implementation Of The EU HTA Regulation (HTAR) For High-Risk Medical Devices: A Qualitative Study. Value Health. 2025 Dec 6:S1098-3015(25)06151-0. doi: 10.1016/j.jval.2025.11.013. Epub ahead of print. PMID: 41360323