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EU AI Act & Medical Devices: Deadline Extended to 2028 for High-Risk Systems
The European Union has extended the compliance deadline for the AI Act for high-risk medical devices and IVDs already regulated by the MDR and IVDR. A provisional agreement on the Digital Omnibus package has postponed the application date by two years to August 2, 2028. This episode explores what this delay means for manufacturers, how it impacts compliance strategies, and the practical steps regulatory and quality teams should take to prepare for the eventual implementation. Key Questions: - What is the new AI Act compliance deadline for high-risk medical devices? - How does the Digital…
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