CER CLINICAL EVALUATION REPORT
The manufacturer of a medical device must produce a clinical evaluation report, CER, to document the clinical evaluation and its result. MEDDEV Guideline 2.7 / 1 rev.4 defines clinical evaluation as a procedure that involves the collection, estimation, analysis, and evaluation of available clinical data to support the compliance of the medical device with the Essential Requirements. The clinical evaluation report or CER must contain sufficient information to be read and understood by an independent agent. You must provide sufficient detail to understand the search criteria adopted by the evaluators, the available data, the assumptions made, and all the conclusions reached. WHAT MUST CONTAIN IN A CER The report must describe the different stages of the clinical evaluation : Stage 0, the scope of clinical evaluation : - explains the scope and context of the assessment, the technology on which the medical device is based, the conditions of use, and the intended purpose of