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
- 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 firstname.lastname@example.org.
You can find more information about fees here.
You can find more information about submission processes in our Operational Framework.