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Guide for Clinical Evaluation reporting


The evaluation report provides an overall evaluation of analysis of pre-market and post-market clinical data that is relevant to the device in question. The CER report must provide the medical device information for approved devices that are sold in the EU. This will report all clinical performances and safety data that has been identified and analysed.


Step 1: Scope and plan

To identify the medical device scope and CER report that establishes a clinical evaluation plan.


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Step 2: Identification of data that is relevant and fitting.

The pre-market and post-market clinical data most be applicable to the identification purpose of the device.

Stage 3:  Assessment of adjective data

The assessment will identify each set of data for the validity of scientific results, comparison to the clinical date, and the weight to the final report.

Stage 4:  clinical data assessment and evaluation

Make the conclusions about how device is compliant, while considering the essential requirements for safety and performance. The analysis of data should include:


Stage 5: Prepare report to finalize contents.

Once data has been assessed, the evaluation of the completed analysis will be recorded. After data analysis, the evaluation report should summarize the data analysis. This report should provide evidence that the conformity assessment complies with requirements, so the device can be approved for sale in European markets. The responsibility lies with the legal manufacturer to summarize clinical data on how their device is performing for the review of notified bodies or other agencies.

Medical Devices are designed with a primary focus of enhancing patient experience. In the innovation process for the betterment of the patient, don’t let regulatory requirements create a barrier

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