As of August 2025, a number of NREC-MD application templates have been updated. This update is part of our ongoing efforts to streamline the application process and enhance user experience for sponsors and applicants.
The table below 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 2 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 However, please note that following this, the outdated version will no longer be accepted.
Should you have any questions regarding the above updates, please do not hesitate to contact us devices@nrec.ie