CAAmendment object
All changes in the protocol (relating to the device, aspects of clinical investigation plan, investigator, or investigation sites)
Yes
A standard application form ('Application for Amendments to Clinical Investigations on Medical Devices') is available on the HPRA website in section Medical Devices>Regulatory Information> Clinical Investigations.
Technical amendments to the existing protocol will require specific application with further supporting documentation for review by the HPRA. Such applications should be accompanied by the relevant fee.
The CA retains the right to request a new clinical investigation notification if the modification to the protocol is thought to increase the risk to either the patient or the user, or if the Competent Authority considers that the changes proposed constitute a new investigation.