Using medical devices and IVDs subject to clinical research
This page is for hospitals and healthcare professionals.
It describes the key considerations for principal investigators involved in clinical investigations and performance studies in Ireland.
What are clinical investigations and performance studies?
A clinical investigation is a systematic study involving one or more human subjects that assesses the safety or performance of a medical device.
A performance study aims to establish or confirm the analytical or clinical performance of an IVD.
The information on this page applies to performance studies as well as clinical investigations.
How can hospitals use medical devices or IVDs subject to clinical research?
Hospital may use medical devices or IVDs subject to clinical research under various scenarios. These are described below.
Hospitals sponsoring clinical investigations or performance studies
Hospitals can conduct (i.e. be the sponsor of) their own clinical research.
In this scenario, a hospital will be responsible for the initiation, for the management and setting up of the financing of the research.
If you intend to carry out clinical research for medical devices or IVDs, we encourage you to contact us at devices@hpra.ie to set up a preliminary or pre-submission meeting.
For more detailed information about clinical investigations, please review our webpage.
For more detailed information about performance studies, please review our webpage.
Hospitals participating in clinical investigations or performance studies
A hospital may participate in clinical research without being the sponsor, i.e. where they do not retain legal responsibility for managing the research.
In this scenario, a hospital may participate as an investigation site.
In these cases, the sponsor of the research may be a manufacturer, contract research organisation, academic institution or other entity.
What are the key considerations for hospitals and principal investigators involved in clinical research?
The principal investigator (PI) is a qualified person responsible for conducting the study at a clinical investigation site.
It is important that principal investigators are aware of the requirements outlined in EN ISO 14155 : 2020. This guidance documents outlines what is considered good clinical practice when carrying out clinical investigations of medical devices on human subjects. Key considerations include;
- Qualification of the PI
- Qualification of the Site
- Informed Consent
- Compliance with the Clinical Investigation Plan (CIP)
- Medical Care of Participants
- Safety Reporting
As well as ISO 14155, it is important that the PI is aware of the various requirements outlined in the Clinical Investigation Protocol and the clinical and non-clinical data included in the Investigator’s Brochure. These documents are provided to the PI by the sponsor of the study.