Clinical Investigation Report (CIR)

The Clinical Investigation Report (CIR) compiles the results of a clinical investigation of a medical device. The results should cover subject demographics, analysis of results related to chosen endpoints, details of subgroup analysis, compliance with the clinical investigation plan, follow-up of missing data and of patients withdrawing from the clinical investigation, or lost to follow-up, a summary of adverse events, adverse device effects, device deficiencies and any relevant corrective actions. The report should include a discussion and overall conclusions on safety and performance. Requirements for the CIR are detailed in Annex XV (Chapter III, Section 7) of the Medical Devices Regulation (2017/745).

 

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We would like to thank you thoroughly and emphasize that we very much appreciated your review. Both we and the sponsor have repeatedly stressed during the meetings that your review has been a great value to the quality of our documents. Thank you for this collaboration!

Clinical Research Associate