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Device Company Applicants
GENERAL OVERVIEW:
Could you give me a general overview of the situation in Ireland in respect of applying for ethical approval for device trials or registries of devices?
Yes. Ireland has a very robust medical device industry. For more information, contact the Irish Medical Device Association.
Clinical Investigations of medical devices in humans always require ethical approval.
Registries of medical devices in humans always require ethical approval.
Many, but not all, institutions in the Republic of Ireland will have an affiliated research ethics committee whose role it is to give an ethical opinion in relation to all research being undertaken in that institution. Device Trials can be single centred (one site only) or multi-centred. If the device trial is multi-centred, then several ethics committees may be reviewing the application on behalf of different sites. Different Ethics Committee may have different application forms; and fees for ethical review will differ from committee to committee.
Some clinical investigations of medical devices will also require a review from the Medical Devices Section of the Irish Medicines Board. If you are unsure if IMB approval will apply in case of your investigation, the Irish Medicines Board (Medical Device Section) will be able to assist.
This also applies if you are unsure which CLASS of Medical Device your particular device is classed as.
Registries of Medical Devices are common and often involve multiple sites, and therefore applications to a number of ethics committees. Registries of medical devices are in effect electronic databases, and do not require Irish Medicines Board approval.
Clinical Investigations of Medical Devices
I represent a device company and am preparing to submit an application to Beaumont Hospital Ethics (Medical Research) Committee. What do I need to know?
Firstly, the committee's opinion is limited to Beaumont Hospital, St. Joseph's Hospital Raheny and St. Ita's Hospital, Portrane. If your study includes sites other than these, please contact the ethics committee relevant to those sites for ethical approval to proceed at those other sites.
Secondly, an application (in some cases) must be made to Medical Devices Section of the Irish Medicines Board.
Step 1:
Contact the Medical Devices Section of the IMB. The IMB will advise you as to whether a full application to the IMB is required. (Of note, not all clinical investigations of medical devices require IMB approval and a combination of factors including the classification of the device, whether the device is being used within the terms of its CE Mark, whether the device has a CE Mark and whether there is commercial intent will be used by the IMB to decide whether IMB review / approval is required.)
Step 2:
Apply to the IMB (if applicable) and Apply to the ethics committee at each relevant site.
Step 3:
Send your Ethics Committee Approval and IMB Approval or IMB letter to the Hospital CEO.
Step 4:
With CEO permission (in the form of signed Forms of Indemnity and Contracts or Agreements) begin the trial.
I represent a device company and am preparing to submit an application to Beaumont Hospital Ethics (Medical Research) Committee. Please comment on indemnity and insurance.
The Committee will seek to review copies of the draft Form of Indemnity, the draft Clinical Trial Agreement (or equivalent) and the sponsor's Certificate of Insurance.
Please note that the HSE Form of Indemnity is compulsory for use in the Republic of Ireland.
Registries of Medical Devices
I represent a Medical Device Company, and the research I hope to pursue can be classed as a "Registry". It has ethical approval to proceed from a recognised ethics committee. Is this approval valid for Beaumont Hospital?
No. Recognised ethics committees can give approval for the state of Ireland for clinical trials of medicinal products only. An application should be made to Beaumont Hospital Ethics (Medical Research) Committee in respect of all other types of research, including registries. The opinion of any other ethics committee is not valid for Beaumont Hospital.
Please note that the position in Ireland in respect of the requirement for ethical review of 'registries' may differ from that in other European countries.
I represent a device company and am preparing to submit an application in respect of a 'Registry' to Beaumont Hospital Ethics (Medical Research) Committee. Please comment on indemnity and insurance.
The Committee will seek to review copies of the draft Form of Indemntiy, the draft Clinical Trial Agreement (or equivalent) and the sponsor's Certificate of Insurance.
Please note that the HSE Form of Indemnity is compulsory for use in the Republic of Ireland.
Although this form is particularly relevant in the context of clinical trials, the committee's standpoint is that this form should also be completed for all research involving where an external agency is the sponsor. External agencies include device manuafacturers, device companies and universities.
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