EC Medical Devices · August 23, 2025

MDCG 2025-6 – FAQ on interplay between Medical Devices Regulation, In Vitro Diagnostic Regulation and AI Act

Original title: MDCG 2025-6 - FAQ on Interplay between the Medical Devices Regulation & In vitro Diagnostic Medical Devices Regulation and the Artificial Intelligence Act (June 2025)

MDCG publishes FAQ clarifying how MDR, IVDR and AI Act obligations apply concurrently to medical devices and IVDs incorporating AI.

Medium impact Medical Devices & IVD Digital Health & AI EU-wide medical-devicesivdai-actai-governance

News announcement19 June 2025MDCG 2025-6 - FAQ on Interplay between the Medical Devices Regulation & In vitro Diagnostic Medical Devices Regulation and the Artificial Intelligence Act (June 2025)1 min read

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Published by EC Medical Devices. HealthSignal links to the original document; the summary above is extracted from the source text.