The Clinical Evaluation Report (CER) comprises of three major parts that present complete clinicalevaluation information of the medical device under consideration. The first section is a report of the new clinical investigations of the device conducted by the manufacturer. The second section deals with the unpublished data concerning the biological safety and bench testing of the medical device along with compliance and experience records. The third part of the CER deals with the literature review of the clinical evaluation published on equivalent devices.
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