What is a clinical investigation?
Clinical investigations are usually required to gather clinical data that is sufficient to demonstrate conformity of a non-CE marked medical device to the requirements of the Medical Devices Regulations.
When do the HPRA get involved?
When clinical investigations of non-CE marked devices are to be carried out in Ireland, an application is required to be sent to the HPRA. Typically applications are submitted by medical device manufacturers. We encourage pre-submission meetings with potential sponsors of clinical investigations.
Clinical investigation applications will receive a unique identification number, CIV ID, (if not previously assigned) for the purposes of notification to the EUDAMED database. Applications to conduct clinical investigations are validated for completeness prior to the investigation starting. The HPRA reviews the regulatory, technical and clinical aspects of the application. We aim to provide an initial response on the application by day 30 of the 60 days allowed.
The HPRA reviews applications to conduct clinical investigations in Ireland in parallel with Ethics Committee review.
If the review has a satisfactory outcome, the sponsor will be issued with a “Letter of no objection”. In order for any clinical investigation to commence in Ireland, both the HPRA and the Ethics Committee must have issued a final positive opinion. The final opinion of the Ethics Committee must be submitted to the HPRA prior to commencement of the investigation.
Some clinical investigations, such as those using CE marked devices within their intended purpose, may not require review. The HPRA is happy to discuss what type of device investigations require notification and review with individuals intending to conduct clinical investigations involving devices.
It should be noted that there is no specific legislation relating to clinical investigations involving in-vitro diagnostic medical devices. Rather, in-vitro diagnostic medical devices have to undergo performance evaluation as specified under Annex VIII of the In-vitro Diagnostic Medical Devices Directive 98/79/EC.
How can I apply for approval of a clinical investigation?
If you wish to submit an application to conduct a clinical investigation in the Republic of Ireland to the HPRA please use our application form for clinical investigations on medical devices.
A list of cut-off dates for the submission of clinical investigation applications are available for 2018
Clinical Investigation Amendments
If an amendment to a clinical investigation, which has previously received a 'Letter of no objection', is required, sponsors must submit an application form for an amendment to a clinical investigation on medical devices. Please note that this is applicable to both administrative and technical amendments.
A guidance document for Irish Research Ethics Committees conducting reviews of clinical investigations involving medical devices is available; please see the HPRA Guide for Ethics Committees on Clinical Investigation of Medical Devices.
How much does it cost?
A fee is payable. Further details are included in our:
Further guidance on clinical investigation is available:
- 93/42/EEC (e.g. Article 15, Annexes I, VIII, Annex X) or 90/385/EEC (e.g. Article 10, Annexes 1, 6, 7)
- ISO 14155 Parts 1 & 2 – Clinical Investigations involving medical devices in human subjects
- MEDDEV 2.7-1 Clinical evaluation: Guide for manufacturers and notified bodies (including Appendix 1 Clinical Evaluation of Coronary Stents)
- MEDDEV 2.7-2 Guide for Competent Authorities in making an assessment of clinical investigation notification
- NBMED 2.7 rec3 Evaluation of clinical data - clinical investigations, clinical evaluation
- GHTF SG5(PD)N3R7 Clinical Investigations (draft)
If you would like to know more information about Clinical Investigations please contact the Human Products Authorisation and Registration Department at firstname.lastname@example.org.