Clinical evaluation is the assessment and analysis of clinical data pertaining to a medical device in order to verify the clinical safety and performance of the device.—Global Harmonization Task Force
There are several stages:
Stage 1: identify clinical data from literature search;
Stage 2: literature screening and selection, in terms of its suitability, applicability, quality and clinical significance. Some publications are excluded according to exclusion criteria. For potentially eligible literature, full texts are consulted for a more detailed assessment. More papers are excluded at this time.
Stage 3: Papers with relevant, usable data on device performance and safety are included in the clinical evaluation analysis. Detailed appraisal criteria for suitability are used and Oxford Level of Evidence is assigned to all included papers.
After the clinical evaluation process, a CER report is compiled.