What is the role of a Clinical Evaluation Report (CER) in CE marking?

• A. A marketing brochure used to promote the device
• B. A document compiling evidence from clinical data demonstrating device safety and performance
• C. A set of manufacturing process instructions
• D. A regulatory submission for the US FDA

Answer: (B)

A Clinical Evaluation Report is the formal, evidence-based justification that a medical device is safe and performs as intended, and it forms a central part of the documentation needed for CE marking. It brings together all relevant clinical data—published literature, results from any clinical investigations you conducted, and real-world post-market surveillance—to show how the device performs in clinical practice. The report explains the context, lays out how the data were searched and appraised, and assesses the quality and applicability of each data source. It then synthesizes the findings to determine whether safety and performance requirements are met and describes any residual risks and how they’re managed. Because CE marking hinges on credible clinical evidence, the CER is reviewed by the notified body as part of the conformity assessment. It isn’t a marketing brochure, it isn’t a set of manufacturing instructions, and it isn’t a regulatory submission for the US FDA.