Advancing Ireland's medtech clinical research ecosystem: insights, comparisons, and actionable recommendations
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Date
2025-04
Authors
Ryan, Fiona
Journal Title
Journal ISSN
Volume Title
Publisher
Health Research Board National Clinical Trials Office
Published Version
Abstract
This report summarises a survey conducted to assess medtech industry stakeholders' experiences and perspectives regarding the conduct of clinical investigations both in Ireland and internationally. Respondents included companies and organisations actively engaged in clinical medtech research, providing insights into regulatory processes, workforce challenges, patient recruitment, and compliance with the EU Medical Device Regulation (MDR). Key findings highlight widespread recognition of Ireland’s strengths—particularly its infrastructure and regulatory clarity—tempered by challenges related to skill gaps and lengthy approval timelines. Recommendations emphasise improving regulatory efficiency, addressing skills shortages, and fostering EU-wide harmonisation to bolster Ireland's competitiveness.
Description
Keywords
Clinical investigations , Ireland , Clinical medtech research , EU Medical Device Regulation (MDR)
Citation
Ryan, F. (2025) Advancing Ireland's medtech clinical research ecosystem: insights, comparisons, and actionable recommendations. Cork: Health Research Board National Clinical Trials Office, pp. 1-32.