This insight brief addresses the growing complexity of Clinical Evaluation Reports (CERs) under EU MDR and global regulations. It outlines common deficiencies seen during reviews, including weak clinical evidence strategies, poor data integration, and lack of traceability. The document presents best practices for building robust CERs by aligning clinical data, literature, post-market surveillance, and risk management. IQVIA’s structured, end-to-end approach helps manufacturers improve consistency, strengthen clinical justifications, and maintain inspection readiness. The brief underscores the importance of proactive CER planning to support regulatory approvals, renewals, and long-term device sustainability.

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