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Reminder: The current consultation on IMDRF/CEIVD WG/N91 Draft: 2026 – Clinical Evidence for IVD Medical Devices: Definitions and Principles of Performance Evaluation will close on 5 May 2026.
Global Harmonization Working Party (GHWP) has voluntarily withdrawn from IMDRF.
From May 2025, all IMDRF related forms will be available online from IMDRF’s Citizen Space site.
Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices: Workshop record available fthrough GRRP Working Group