Apply to NREC-MD

The NREC-MD will review applications related to Clinical Investigations of Medical Devices.

When applying to the NREC-MD, please use the templates below for the Application Form, Documentation Checklist and the Site Suitability template.

Where necessary, the NREC-MD will continue to accept the Standard Application Form ‘Adapted Version (August 2018) for the Ethical Review of Health-Research Studies, which are not Clinical Trials of Medicinal Products for Human Use as defined in S.I. 190/2004’ until January 2022. In such cases, applications must include an Application Appendix, which includes new questions found in the NREC-MD Application Form.

Please ensure all the following documentation is included as part of your application:

  • Application Form
  • Checklist
  • Evidence of Fee Payment
  • Cover Letter on headed paper
  • Summary CV for Principal Investigator
  • Research Participant Information Leaflet
  • Research Participant Consent Form
  • Insurance / Indemnity Certificate (for each site)
  • Site Suitability Form or Site-Specific Assessment Form (for each site)
  • Data Protection Impact Assessment (or statement why not required)
  • Details of any Data Monitoring Committee
  • Signed Statement of Conformity to Safety and Performance Requirements
  • Letter from Sponsor confirming outsourcing of duties and functions
  • Case Report Form
  • Copies of Advertisement Material for Research Participants, e.g. posters, newspaper adverts, website. For video or audio recordings, please also provide the printed script.
  • Clinical Investigation Plan
  • Investigator Brochure

Additional Documentation (if available):

  • Letter of Invitation for participant
  • Next-of-Kin Information Leaflet and Assent Form
  • Diary Card/Participant Card
  • Validated Questionnaire
  • Non-validated Questionnaire

Applications that do not include the relevant documentation or information will be deemed invalid and will require resubmission.

All applications should be sent as a zipped folder to devices@nrec.ie.

You can find more information about fees here.

You can find more information about submission processes in our Operational Framework.

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