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.
Is Your Clinical Evaluation MDR-Ready?
Is your Clinical Evaluation ready for MDR scrutiny?
This expert guide walks regulatory and clinical affairs professionals through the latest EU MDR expectations under Article 61 and Annex XIV—covering GSPR alignment, evidence standards, equivalence justifications, and audit-readiness strategies.
UK PMS Regulations vs EU MDR
With the right updates, existing MDR-compliant systems can be efficiently adapted to meet the new MHRA requirements.
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