Finland Fimea · August 25, 2026

Application of the AI Act transparency obligation in medical devices

Original title: Tekoälyasetuksen avoimuusvelvoitteen soveltaminen lääkinnällisissä laitteissa

Guidance on how the AI Act's transparency requirements apply to artificial intelligence used in medical devices.

High obligation Sector Medical Devices & IVD Digital Health & AI Finland Medical devicesSoftware as a medical deviceAI governanceEU AI Act
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