Clinical Investigations

Clinical Investigations

in Ireland

Before starting to enroll participants in a clinical investigation or performance evaluation of your device, the following steps should be followed:

  • Find a site and engage with clinical partners.
  • Prepare documentation in line with the Medical Device Regulations (MDR).
  • Obtain approval from the Competent Authority in Ireland – The Health Products Regulatory Authority (HPRA) and the National Office for Research Ethics Committees (NREC).

Further information on each step is provided below.

Research Infrastructure in Ireland: The HRB NCTO provides an integrated national clinical research network to help identify supports and sites within the Clinical Research Facilities/Centres (CRF/Cs) network and beyond to help facilitate your study.

The NCTO can help you find suitable clinical sites for your clinical investigation through the HRB NCTO National Study Feasibility Programme.

MedTech Regulations: Medical Devices and In-Vitro Diagnostics are highly regulated. In Ireland, companies and researchers must adhere to European and Irish medical device regulations.

The HPRA acts on behalf of the Irish government to regulate human and veterinary medicines, clinical trials, medical devices, controlled drugs, blood and blood components, tissues and cells, and cosmetic products.

The HPRA is the only Irish national competent authority. It is responsible for enforcing the European Medical Device Regulations (Medical Devices Regulation (EU) 2017/745), providing authorisation of clinical investigations, and monitoring the safety and compliance of medical devices with national laws.

The Guide to Medical Device Clinical Investigation application to HPRA is a helpful document that outlines the requirements and process for submitting an application to the HPRA.

A preliminary meeting can be set up for early-stage ‘start-up’ companies to understand the HPRA role and the regulatory requirements of the pre-market phase of device development.

A presubmission is typically used by sponsors who plan to submit a clinical investigation application and get answers to any questions at the meeting before submitting an application.

The National Office for Research Ethics Committees was set up to provide a single, independent ethics opinion on whether research or investigations are ethical to protect the safety, dignity and well-being of participants.

The National Research Ethics Committee for Clinical Investigations of Medical Devices and Performance Studies of In Vitro Diagnostic Medical Devices (NREC-MD) review submissions of ethics applications regulated under the MDR (Medical Devices Regulation (EU) 2017/745).

Applicants must submit the NREC-MD application form and checklist using the NREC-MD documentation templates and check the Submission cut-off dates.