CLINICAL INVESTIGATION (CI) is a systematic study involving one or more human subjects that assesses the safety or performance of a medical device.
As part of this guide, the Health Products Regulatory Authority provides guidance on the legislation on clinical investigations using medical devices as well as information on how to submit applications to carry out these CIs.
In general, to conduct a CI in Ireland the applicant/company need to:
Submit an application or notification to HPRA.
Apply to the National Research Ethics Committee for Medical Devices (NREC-MD).
Fulfill other requirements such as adverse event reporting.
If the planned modification to the CI is substantial, you must submit a notification to HPRA for assessment before making the modification.
In Ireland, all clinical investigations must receive ethics approval from the National Research Ethics Committee – Medical Devices (NREC-MD) before the CI starts. The NREC-MD review is independent from HPRA review.
The applicant/company can apply to the NREC-MD and to the HPRA at the same time or at different times, but the CI cannot start until both reviews are complete.
Click this LINK to know more about the 3 types of CI's and the Submission review process.