NREC-MD:
New clinical investigations/
Performance studies
If you wish to apply to the NREC-MD for a new clinical investigation or performance study, please use the templates below for the Application Form, Documentation Checklist and the Site Suitability template. For more information on the application and review process, please visit the NREC-MD FAQs.
Please note that all applications submitted for the 18 August 2022 NREC-MD meeting must be accompanied by the V3 of the Application Checklist.
Please note, all applications submitted for the 15 September 2022 NREC-MD meeting must be accompanied by the V3 of the Application Form.
Please follow the NREC-MD Documentation Checklist when compiling your application dossier.
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.