Navigating Implementation of the EU HTA Regulation for Medical Devices: Insights From National HTA Bodies Across Europe
Author(s)
Rasha A. Alshaikh, PhD1, Kieran A. Walsh, PhD2, Susan Spillane, MSPH, PhD3, Patricia Harrington, PhD3, Michelle O'neill, PhD2, Conor Teljeur, BS, MSc, PhD3, Mairin Ryan, PhD3, Caitriona O'Driscoll, PhD1.
1University College Cork, School of Pharmacy, Cork, Ireland, 2Health Information and Quality Authority, Cork, Ireland, 3Health Information and Quality Authority, Dublin, Ireland.
1University College Cork, School of Pharmacy, Cork, Ireland, 2Health Information and Quality Authority, Cork, Ireland, 3Health Information and Quality Authority, Dublin, Ireland.
OBJECTIVES: The EU Health Technology Assessment Regulation (HTAR) introduces Joint Clinical Assessments (JCAs) as a mechanism to harmonise clinical evidence evaluation across Member States. Distinct from pharmaceuticals (commencing in 2025), JCAs for high-risk medical devices (MD) and in-vitro diagnostics (IVD) commence in 2026. Little is known about how national health technology assessment (HTA) bodies are preparing for the implementation for high-risk MD/IVD. This study aims to explore how selected EU/EEA HTA bodies are planning for the implementation of the HTAR for high-risk MD/IVD, with a focus on perceived challenges and opportunities during the implementation phase.
METHODS: Semi-structured interviews were conducted with 15 participants from 11 different HTA bodies across 11 EU/EEA Member States, identified through publicly available contact information or the authors’ network. Interviews were recorded and transcribed verbatim before being anonymised and coded using NVivo Software. Data were analysed using thematic analysis.
RESULTS: Despite heterogeneity in current HTA frameworks and reimbursement pathways for MD/IVD, all participants recognised JCAs as a potential tool for improving evidence and assessment quality for high-risk devices and highlighted their intention to use JCA-generated evidence in their clinical assessment. Some HTA bodies have initiated local procedural or legislative adaptations; however, many are awaiting further EU-implementation documents before deciding their approach. Key opportunities identified included work-sharing, improved evidence standards, and capacity-building. However, substantial challenges, including regulatory uncertainty, potential timing misalignments between EU and national processes, and limited manufacturer preparedness for JCA evidence demands, were highlighted.
CONCLUSIONS: HTAR is widely viewed as an opportunity to reform and strengthen HTA practices for high-risk MD/IVD. However, realising its goals will require further collaboration, alignment of procedural timelines, and investment in national capacity. Moreover, post-HTAR implementation studies will be required to capture its impact on practice.
METHODS: Semi-structured interviews were conducted with 15 participants from 11 different HTA bodies across 11 EU/EEA Member States, identified through publicly available contact information or the authors’ network. Interviews were recorded and transcribed verbatim before being anonymised and coded using NVivo Software. Data were analysed using thematic analysis.
RESULTS: Despite heterogeneity in current HTA frameworks and reimbursement pathways for MD/IVD, all participants recognised JCAs as a potential tool for improving evidence and assessment quality for high-risk devices and highlighted their intention to use JCA-generated evidence in their clinical assessment. Some HTA bodies have initiated local procedural or legislative adaptations; however, many are awaiting further EU-implementation documents before deciding their approach. Key opportunities identified included work-sharing, improved evidence standards, and capacity-building. However, substantial challenges, including regulatory uncertainty, potential timing misalignments between EU and national processes, and limited manufacturer preparedness for JCA evidence demands, were highlighted.
CONCLUSIONS: HTAR is widely viewed as an opportunity to reform and strengthen HTA practices for high-risk MD/IVD. However, realising its goals will require further collaboration, alignment of procedural timelines, and investment in national capacity. Moreover, post-HTAR implementation studies will be required to capture its impact on practice.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HPR145
Topic
Health Policy & Regulatory, Health Technology Assessment, Medical Technologies
Topic Subcategory
Reimbursement & Access Policy
Disease
No Additional Disease & Conditions/Specialized Treatment Areas