HIQA Publishes Report on European Medical Device Assessment Led by UCC School of Pharmacy Researchers
The Health Information and Quality Authority (HIQA) published a new report, 'Review of the European Landscape for Assessment of High-Risk Medical Devices in the Context of EU HTAR', on 29 October 2026. The report is based on research led by researchers from the School of Pharmacy, University College Cork, in collaboration with HIQA and with funding from Rinn Medical Devices.
The study examined how European countries assess high-risk medical devices and in vitro diagnostics (IVDs), and how national Health Technology Assessment (HTA) bodies are preparing for the implementation of the EU Health Technology Assessment Regulation (HTAR).
Through mapping national assessment and reimbursement pathways and interviewing experts from 11 European HTA bodies, the research identified key challenges, differences in national approaches and opportunities for greater European collaboration.
The research team included Prof Caitriona O'Driscoll, Emeritus Professor at UCC School of Pharmacy; Dr Rasha Alshaikh, Lecturer in Pharmacology and Therapeutics at UCC; Dr Fatma El-Komy of HIQA; and Dr Kieran Walsh, Deputy Director of HTA at HIQA and Adjunct Clinical Senior Lecturer at UCC School of Pharmacy.
The report provides insights into current European assessment practices and the challenges facing national HTA bodies as they prepare for the new regulatory framework.
Read the full report: HIQA website