EU MDR extension to 2027 reshapes the IVD Hardware compliance window. Learn how the October 2026 MDCG 2023-4 rule impacts CE filings, notified body timing, and EU export planning.

FDA Mandates New eSTAR Validation Module for IVD Hardware: learn how the August 1 FDA eSTAR update and ISO/IEC 17025 metadata rules may affect U.S. filings, timelines, and compliance risk.

FDA shifts IVD Hardware evidence filing to eSTAR starting August 1, 2026. Learn how the new FDA rule impacts clinical validation, compliance costs, customs clearance, and U.S. export readiness.

FDA requires IVD hardware validation summary within 72 hours for 510(k) and De Novo filings. Learn how this urgent rule affects compliance, importers, timelines, and shipment risk.