Clinical Investigation Support for Medtech Companies, Academics and Entrepreneurs in Ireland

Providing access to a dedicated Medtech expert and information on key regulatory requirements.

Here you will find more information on how to conduct a clinical investigation in Ireland, the supports and infrastructure available to Medtech clients and how to navigate the ecosystem.

If you are developing a medical device and have any questions about conducting clinical investigations in Ireland, please find more detail by visiting our CILO Page or by emailing

To start recruiting patients for a Clinical Investigation of a Medical Device under the Medical Device Regulations (MDR), you will need to obtain approval from the Competent Authority in Ireland (The Health Products Regulatory Authority (HPRA) and the National Office for Research Ethics Committees (NREC).

An overview of the steps required to gain approval for your planned Clinical Investigation is detailed here.

A guide to the regulations, guidelines, ISO standards and other helpful information related to conducting clinical investigations in Ireland and Europe can be found on our MedTech Regulations page.

The toolkit is intended to provide information to anyone planning to conduct clinical investigations of medical devices in Ireland. The information may be beneficial for both academic and commercial investigators and their teams. Our Medtech Toolkit which is available upon request, click here for more information.