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. The 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 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 enough detail to understand the search criteria adopted by the evaluators, the data available, the assumptions made, and any conclusions reached. WHAT SHOULD A CER CONTAIN It is important that the report describes the different stages of the clinical evaluation: Stage 0, scope of clinical evaluation: – explains the scope and context of the evaluation, the technology on which the medical device is based, the...