Articles & Guides

Expert insights on medical device classification, regulatory compliance, and industry best practices.

EU MDR Classification Guide 2026: Annex VIII Made Simple

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Clinical Evaluation Report for Medical Devices: 2026 Guide

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Medtech's Launch Pipeline Is Thin. That Makes Every Submission More Expensive to Get Wrong.

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The EU Just Made Drug Exclusivity Conditional. Device Regulatory Teams Should Watch Why.

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The FDA Just Said AI Devices Need Lifecycle Proof. Does Your AI-Drafted CER?

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MDR Transition Deadlines: What 31 December 2027 and 2028 Mean for Your Legacy CER

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What a Legacy CER Gap Analysis Actually Checks

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EU Joint Clinical Assessment Is Starting: Is Your CER Ready for PICO?

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This Week's Biggest Medtech Deals Have One Thing in Common: De-Risked Regulatory Pathways

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Why Washington Just Out-Paced Brussels on AI Device Rules

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When a Device Changes Hands: The Technical File and CER Handover Checklist

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AI in Regulatory Affairs: What Responsible, Audit-Ready Use Looks Like

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Simplification Is Not Deregulation: What the MDR Reform Means for Your CER Strategy

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