Apply to NREC-MD
The NREC-MD reviews applications related to Clinical Investigations of Medical Devices and Performance Studies of In Vitro Diagnostic Medical Devices.
The links below or in the side menu will take you to the relevant web page, where you can find more information and the relevant documentation.
Pre-submission meetings
If you have any questions about your application, or wish to discuss the submission process with the National Office team, we would be happy to facilitate a pre-submission meeting.
If you would like to avail of a pre-submission meeting, please contact us at devices@nrec.ie with your availability and a full list of queries for discussion.
For more information on the application and review process, please visit the NREC-MD FAQs.
NOTE: Updated application templates NREC-MD. See below table for details:
We wish to inform you that as of August 2025, we have updated a number of NREC-MD application templates. The table below email lists the updated templates and provides a summary of changes to the templates.
| Template name | Valid version number | Outline of changes |
| NREC-MD Application form | V5 | The revision of the NREC-MD application form introduces two distinct forms: one for clinical investigations of medical devices and one performance studies of in-vitro diagnostic medical devices. The content of the form has been updated to streamline the questions. Finally, to facilitate easier submission of combined applications, the following sections of the application form has been revised as per the national CTR Part II templates:
|
| NREC-MD Application Checklist for clinical investigations of medical devices and performance studies of in-vitro diagnostic medical devices | V4 | The checklists were revised to reflect revised documentation requirements, eg by removing cover letter as a required document. |
| NREC-MD Site Suitability Form | V5 | Updated formatting to align with updated NREC-MD application form. |
| NREC Statement of Compliance | V2 | Input from site Data Protection Officers (DPOs) is no longer required. We hope this change will reduce the administrative burden on sponsors when preparing an application |
| NREC-MD Substantial Modification form | V4 | Streamlined content and updated formatting. |
To support a smooth transition, we will continue to accept the previous versions of templates until the 31 December 2025. However, please note that following this, the outdated version will no longer be accepted.
This update is part of our ongoing efforts to streamline the application process and enhance user experience for sponsors and applicants.