Under the EU MDR, the Clinical Evaluation Report (CER) is no longer a static document. It is the beating heart of your technical file. Notified bodies are scrutinizing the methodology used in literature searches and the robustness of the data linking clinical benefits to safety.

State of the Art (SOTA)

A frequent pitfall is failing to establish a comprehensive SOTA. Your CER must analyze alternative treatments, competitor devices, and the current clinical guidelines to prove that your device's risk-benefit profile remains acceptable in the modern clinical landscape.

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