Medical device toolkit - Clinical investigations in Ireland and European medical device regulations
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Date
2025-03
Authors
Ryan, Fiona
Journal Title
Journal ISSN
Volume Title
Publisher
Health Research Board National Clinical Trials Office
Published Version
Abstract
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.
Description
Keywords
Toolkit , Ireland , Clinical investigations of medical devices , International standards , European regulations , Medical device , Classification , Risk management , Quality management
Citation
Ryan, F. (2025) Medical device toolkit - Clinical investigations in Ireland and European medical device regulations. Cork: Health Research Board National Clinical Trials Office, 57pp.