Medical device toolkit - Clinical investigations in Ireland and European medical device regulations

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dc.contributor.authorRyan, Fionaen
dc.contributor.funder2025Health Research Boarden
dc.date.accessioned2025-04-16T08:37:13Z
dc.date.available2025-04-16T08:37:13Z
dc.date.issued2025-03en
dc.description.abstractThe 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.en
dc.description.versionPublished Versionen
dc.format.mimetypeapplication/pdfen
dc.identifier.citationRyan, F. (2025) Medical device toolkit - Clinical investigations in Ireland and European medical device regulations. Cork: Health Research Board National Clinical Trials Office, 57pp.en
dc.identifier.endpage57en
dc.identifier.startpage1en
dc.identifier.urihttps://hdl.handle.net/10468/17275
dc.language.isoenen
dc.publisherHealth Research Board National Clinical Trials Officeen
dc.rights© 2025, the Author. Open Access.en
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/en
dc.subjectToolkiten
dc.subjectIrelanden
dc.subjectClinical investigations of medical devicesen
dc.subjectInternational standardsen
dc.subjectEuropean regulationsen
dc.subjectMedical deviceen
dc.subjectClassificationen
dc.subjectRisk managementen
dc.subjectQuality managementen
dc.titleMedical device toolkit - Clinical investigations in Ireland and European medical device regulationsen
dc.typeReporten
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