Medical Device Regulation 2017/745 Clinical Evaluation Report: Generalities

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Clinical evaluation is the procedure through which it is possible to appraise, collect and analyse clinical data for a medical device to assess whether the available data is sufficient to meet MDR requirements. The results of the evaluation should be documented in a clinical evaluation report (CER).  This implementation tool provides on overview of the information to be included in the clinical evaluation report and a useful template to use as a guidance.

PREVIEW: MDR Clinical Evalution Report Generalities


Date of publication: May 2019