Clinical Evaluation Report Basics from the Perspective of a Medical Writer
Posted on April 25, 2024 in Resources
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Clinical Evaluation Report Basics from the Perspective of a Medical Writer
Given the changing regulatory environment in the European Union, revisiting the fundamental principles of the clinical evaluation report (CER) as outlined by Regulation 2017/745 (EU MDR) can be beneficial. This overview of CER basics comes from the viewpoint of an experienced regulatory writer focusing on medical device submissions.
Clinical Evaluation Report Basics from the Perspective of a Medical Writer