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 clinical investigations of non-CE marked devices are to be carried out in Ireland, an application is required to the IMB. Typically applications are submitted by commercial sponsors e.g. medical device manufacturers. The IMB encourages pre-submission meetings with potential sponsors of clinical investigations.
Applications to conduct clinical investigations are reviewed by Human Products Authorisation & Registration Department of the IMB prior to the investigation starting. The IMB reviews the regulatory, technical and clinical aspects of the application. The IMB aims to provide an initial response on the application by day 30 of the 60 days allowed.
Applications may be made by completing the Application for clinical investigations on medical devices form.
Clinical investigation applications will receive a unique identification number, CIV ID, (if not previously assigned) for the purposes of notification to the EUDAMED database.
The IMB reviews applications to conduct clinical investigations in Ireland in parallel with Ethics Committee review.
If the IMB 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 IMB and the Ethics Committee must have issued a final positive opinion. The final opinion of the Ethics Committee must be submitted to the IMB prior to commencement of the investigation.
If an amendment to a clinical investigation, which has previously received a 'Letter of no objection', is required, sponsors must complete and submit the Application for amendments to clinical investigations on medical devices form. Please note that this is applicable to both administrative and technical amendments.
Some clinical investigations, such as those using CE marked devices within their intended purpose, may not require review. The IMB is happy to discuss what type of device investigations require notification and review by the IMB with individuals intending to conduct clinical investigations involving devices.
Queries should be sent to clinical.ix@imb.ie.
Individuals considering conducting clinical investigation should refer to:
1. IMB Guidance Note 5
2. 93/42/EEC (e.g. Article 15, Annexes I, VIII, Annex X) or 90/385/EEC (e.g. Article 10, Annexes 1, 6, 7)
3. ISO 14155 Parts 1 & 2 – Clinical Investigations involving medical devices in human subjects
4. MEDDEV 2.7-1 Clinical evaluation: Guide for manufacturers and notified bodies (including Appendix 1 Clinical Evaluation of Coronary Stents)
5. MEDDEV 2.7-2 Guide for Competent Authorities in making an assessment of clinical investigation notification
6. NBMED 2.7 rec3 Evaluation of clinical data - clinical investigations, clinical evaluation
7. GHTF SG5(PD)N3R7 Clinical Investigations (draft)
A guidance document for Irish Research Ethics Committees conducting reviews of clinical investigations involving medical devices is available, please see the IMB Guide for Ethics Committees on Clinical Investigation of Medical 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.1.