Clinical Evaluation Report
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Use this Clinical Evaluation Report (CER) template to systematically document and assess the clinical evidence supporting your medical device’s safety, performance, and clinical benefits, as required by EU MDR 2017/745. You should complete this template during the pre-market and post-market phases to demonstrate conformity with regulatory expectations, substantiate clinical claims, and ensure ongoing compliance through literature review, risk analysis, and post-market surveillance. This document is essential for regulatory submissions, audits, and maintaining CE mark certification.