Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research
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.
Rasha A Alshaikh, Kieran A Walsh, Susan Spillane, Patricia Harrington, Michelle O'Neill, Conor Teljeur, Máirín Ryan, Caitriona M O'Driscoll
Published: 202510.1016/j.jval.2025.11.013
Abstract
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…
Preview only. Read the full abstract at the source