EU Legacy Devices: Navigating the 'Significant Change' Maze Under MDR & IVDR

Medical Device Global Market Access · Feb 3, 2026 · 3m

This episode delves into the critical definition of a "significant change" for legacy medical devices and IVDs under the EU MDR and IVDR. We explore the official MDCG guidance, outlining what types of modifications can end a device's transitional grace period, forcing an early and costly move to full certification. Learn about the high-stakes impact on market access and the importance of a robust change control process. - What is a "legacy device" and what are the new transition timelines? - How can a minor change to a device jeopardize its EU market access? - What is the difference between a…