Clinical Evaluation Report Basics from the Perspective of a Medical Writer
Posted on April 25, 2024 in White Papers
White Paper
Clinical Evaluation Report Basics from the Perspective of a Medical Writer
In light of the evolving regulatory environment in the European Union (EU), we reexamine the fundamental principles of the Clinical Evaluation Report (CER) as outlined by Regulation 2017/745 (EU MDR) in this white paper. This overview of CER basics is offered through the lens of an experienced regulatory writer focusing on medical device submissions.
Clinical Evaluation Report Basics from the Perspective of a Medical Writer