FormlyAI

Clinical Evaluation Plan

Use this Clinical Evaluation Plan template to systematically outline your strategy for collecting, appraising, and analyzing clinical evidence supporting the safety and performance of your medical device, as required for CE marking under EU MDR. Complete this document before initiating or updating your Clinical Evaluation Report to ensure all regulatory, clinical claims, literature review, and post-market data requirements are addressed and clearly documented for notified body submission or internal compliance.
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