Services
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 (CIP), 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).
Emtex Life Science medical writers can manage and coordinate the document development process (eg, compile contributions, circulate for review, implement comments) and can help to generate a clear, well structured, and coherent document, meeting all regulatory requirements. The medical writers also ensure consistency between the CIR and the CIP.
FAQ: Clinical Investigation Report
What is a Clinical Investigation Report (CIR)?
A CIR compiles the results of a clinical investigation of a medical device. The CIR summarizes the outcomes of the study and evaluates the safety and performance of the device based on the data collected from the subjects.
What information is included in a CIR?
A CIR includes subject demographics, analyses of endpoints, subgroup analyses, compliance with the clinical investigation plan, handling of missing data, and information on subjects who withdrew or were lost to follow‑up. It also includes a summary of adverse events, adverse device effects, device deficiencies, corrective actions, and the overall conclusions on safety and performance.
Which regulations define the requirements for a CIR?
The requirements for a CIR are detailed in Annex XV (Chapter III, Section 7) of the Medical Devices Regulation (2017/745).
How can Emtex Life Science support the preparation of a CIR?
Emtex Life Science can support the CIR process by coordinating contributions from clinical, statistical, and regulatory functions, managing review cycles, implementing comments, and ensuring that the CIR is clearly structured and aligned with regulatory expectations. Emtex can also help ensure consistency between the CIR and the clinical investigation plan.
Why is professional medical writing support valuable for a CIR?
Professional medical writing support is valuable because a CIR must be coherent, accurate, and fully aligned with regulatory requirements. A medical writer ensures clear presentation of results, logical interpretation of data, and consistent documentation, all of which strengthen the quality and reliability of the clinical investigation outcomes.