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).

Contact us

Fill out the form below to request more information.

 

Customer testimonial:

 

“My team has worked with Emtex Life Science for more than 15 years to our entire satisfaction. They are a highly competent and effective group of medical writers. A top team!”

Global Head Regulatory Medical Writing

This website uses (anonymous) analytical cookies.

More info