CASubmissionOfApplication object
Responsible for study submission
Sponsor
Manufacturer acting as sponsor
(Typically, applications are submitted by medical device manufacturers)
Guidance on submission of application available
Yes
Guidance on submission of application
‘Guide for Manufacturers and Sponsors on Clinical Investigations Carried out in Ireland’, available on the HPRA website in section: About us>Publications&Forms>Guidance Documents.
Additional Information
Clinical investigation applications will receive a unique identification number, CIV ID, (if not previously assigned) for the purposes of notification to the EUDAMED database from the HPRA.
