Explore expert insights and strategic guidance across Clinical Evaluation, IVD Performance Evaluation, and Post-Market Clinical Follow-up.
How to Prepare a Clinical Evaluation Plan Aligned with MDR Annex XIV
Under MDR Annex XIV, the CEP is your anchor document. Define scope, map data, integrate risk and PMS, and show foresight. A robust CEP reassures notified bodies and builds a sustainable compliance framework for product safety and performance.
How to Update your Clinical Evaluation for Legacy Devices
MDR demands stronger clinical justification for legacy devices. Whether relying on WET status, Article 61(10), or targeted PMCF, manufacturers need structured Clinical Evaluation planning to demonstrate compliance and safeguard CE certification.
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