Clinical Evaluation Report contents

Our experienced medical device consultants and medical writers prepare Clinical Evaluation Report (CER) for any class of device with any medical device Notified Body. The typical table of contents we do is as follows...

1. Introduction
2. Scope
3. References
4. Definitions
5. Abbreviations
6. General principles of clinical evaluation
• What is clinical evaluation?
• When is clinical evaluation undertaken and why is it important?
• How is a clinical evaluation performed?
• Who should perform the clinical evaluation?
7. Definition of the scope of the clinical evaluation (Stage 0)
8. Identification of pertinent data (Stage 1)
• Data generated and held by the manufacturer
• Data retrieved from literature
9. Appraisal of pertinent data (Stage 2)
• General considerations
• The appraisal plan
• Conduct of the appraisal
10. Analysis of the clinical data (Stage 3)
• General considerations
• Specific considerations
• Where demonstration of conformity based on clinical data is not deemed appropriate
11. The clinical evaluation report (CER, Stage 4)

Supporting annex will prepared by our team. This is only for illustration, The contents of the clinical evaluation report will vary according to the nature and history of the device under evaluation

Clinical Evaluation Report
Clinical Evaluation as per MEDDEV 2.7.1 Rev. 4