HRB Clinical Research Facility at UCC - Reports

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https://hdl.handle.net/10468/17273

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    Medical device toolkit - Clinical investigations in Ireland and European medical device regulations
    (Health Research Board National Clinical Trials Office, 2025-03) Ryan, Fiona; 2025Health Research Board
    The toolkit is intended to provide information to investigators wishing to conduct clinical investigations of medical devices in Ireland. The information may be beneficial for both academic and commercial investigators. In addition, the toolkit provides a high-level overview of the primary international standards and European regulations applicable to all medical device developers. Finally, medical device development terminology and considerations are introduced, including classification, risk management and quality management systems. However, the tool kit does not go in-depth into conformity requirements to prepare a device for clinical investigations. Therefore, the toolkit should not replace professional advice from legal, regulatory, quality and design control experts.
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    Advancing Ireland's medtech clinical research ecosystem: insights, comparisons, and actionable recommendations
    (Health Research Board National Clinical Trials Office, 2025-04) Ryan, Fiona; Health Research Board; Enterprise Ireland; IDA Ireland
    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.