CASubmissionFormat object

Email
Data carrier (CD-rom/DVD)

The HPRA strongly recommends electronic submission by e-mail or on CD/DVD. Electronic submissions are acceptable in Word or pdf format.

Yes

‘Application for Clinical Investigations on Medical Devices’ form (available at HPRA website in section: Medical Devices>Regulatory Information>Clinical Investigations).

An application for a clinical investigation consists of the following:
- A completed ‘Application for Clinical Investigations on Medical Devices’ form
- any required documentation (ist provided in application form)
- the relevant fee

Further guidance on the format of electronic submissions, including file naming conventions, are described in ‘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.

Submission cut of dates: The list of monthly cut-off dates for submission of clinical investigation applications are published on the HPRA website in section: Medical devices>Regulatory Information>Clinical Investigations