Reporting Forms and Templates
As of the 1st of July 2024, the National Office no longer requires the submission of Annual Progress Reports or Safety Reports for clinical investigations and performance studies. Applicants should ensure that all relevant regulatory reporting requirements to the Health Products Regulatory Authority (HPRA) have been met.
End of Study Report:
The End of Study Report must be submitted to the National Office within 12 months of the end of the clinical investigation/performance study. All reporting documents should be submitted to the National Office via email to devices@nrec.ie.