Explore expert insights and strategic guidance across Clinical Evaluation, IVD Performance Evaluation, and Post-Market Clinical Follow-up.
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.
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.
Want strategic updates on UK MDR, EU MDR, IVDR, and post-market compliance?
Join our expert-led newsletter and stay ahead with regulatory insights that matter.