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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