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Audit-ready Clinical Evaluation Reports demonstrate a clear chain of reasoning from claims → endpoints → acceptance criteria → clinical evidence → conclusions → relevant GSPRs, allowing Notified Bodies to verify conformity efficiently. https://images.squarespace-cdn.com/content/v1/648ad45845bc567a651a5946/840a4f91-58f3-4bb3-a4e2-03f9bc6b41b1/cer-scope-lock-traceability-matrix-cep-cer-ifu-alignment.png Blog - 12 Reasons Your CER Might Fail a Notified Body Review in 2026 - Make it stand out Figure 2. A simple internal “scope-lock” matrix helps ensure CEP, CER, and IFU statements remain aligned, preventing scope drift across intended purpose, patient population, device variants, and key claims. https://images.squarespace-cdn.com/content/v1/648ad45845bc567a651a5946/6b9ccd1b-3063-42ce-9c19-73c5d7269943/cer-literature-review-evidence-weighting-methodology.png Blog - 12 Reasons Your CER Might Fail a Notified Body Review in 2026 - Make it stand out Figure 3. 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