Guide to Clinical Investigations Carried Out in Ireland

Health Products Regulatory Authority (HPRA)

dc.contributor.author	Health Products Regulatory Authority (HPRA)
dc.date.accessioned	2025-02-05T17:16:55Z
dc.date.available	2025-02-05T17:16:55Z
dc.date.issued	2024-05-16
dc.identifier.uri	http://hdl.handle.net/10147/644182
dc.description	This guide provides an overview of the legislation on clinical investigations (CIs) involving medical devices. The guide also provides guidance on how to submit applications to carry out CIs in Ireland to the Health Products Regulatory Authority (HPRA). This guide is primarily targeted towards CI sponsors (e.g. manufacturers, academic groups, clinical research organisations), who wish to carry out CIs involving medical devices in Ireland. The information may also be useful for ethics committees and other stakeholders. This guide is not the definite interpretation of the law and/or regulations and is for guidance purposes only. You should consult the relevant legislation relating to medical devices in addition to this guide. The Medical Devices Coordination Group (MDCG) has published a Q&A document (MDCG 2021-6) for CI sponsors. This document describes the different types of CIs and their applicable obligations in detail. MDCG has also published guidance documents on the content of clinical investigation plans (MDCG 2024-3) and investigator brochures (MDCG 2024-5) for CIs. Please read these documents before conducting a CI in Ireland.	en_US
dc.language.iso	en	en_US
dc.publisher	Health Products Regulatory Authority (HPRA)	en_US
dc.relation.ispartofseries	AUT-G0095-7	en_US
dc.rights	Attribution 4.0 International	*
dc.rights.uri	http://creativecommons.org/licenses/by/4.0/	*
dc.subject	REGULATION	en_US
dc.subject	Medicines	en_US
dc.subject	Safety	en_US
dc.subject	CLINICAL INVESTIGATIONS	en_US
dc.title	Guide to Clinical Investigations Carried Out in Ireland	en_US
dc.type	Guideline	en_US
refterms.dateFOA	2025-02-05T17:16:57Z