MakroCare provides end to end Clinical evaluation reports for medical devices. Our expert team can provide CER reports within the time limit.

1. Requirements of
Clinical Evaluation Report for
Medical Device Manufacturers.

2. Clinical evaluation Report
Clinical Evaluation Report is an analysis of
Pre market & post market clinical data of
medical device which includes clinical
performance & Clinical safety .

3. Requirements of CER
• Identification of Clinical Data
• Appraisal of Clinical Data
• Analysis of Clinical Data
• Finalize the Report

4. Identification of Clinical Data
Classify the relevant
Pre-market & Post-market clinical data.

5. Appraisal of Clinical Data
Appraise each identified data set
for scientific validity, relevance to
clinical evaluation.

6. Analysis of Clinical Data
The data analysis should include:
 Benefit/Risk Profile
 Residual Risks
 Uncertainties or Unanswered Questions

7. Finalize the Report
After data analysis, the evaluation report should summarize
the data analysis. This report should provide strong clinical
evidence for conformity assessment so the device can be
approved for sale in European markets.