EC Medical Devices · August 23, 2025

MDCG 2025-6 – FAQ on Interplay between Medical Devices Regulation, In vitro Diagnostic Medical Devices Regulation and the Artificial Intelligence 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 guidance clarifies how the AI Act applies to medical devices and IVDs, addressing regulatory overlap and compliance requirements.

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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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