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

All application documents should be numbered and file names should include version number and date.

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 the NREC-MD meeting and cut off dates here.

You can find more information about fees here.

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

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