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Application of the AI Act’s transparency obligation to medical devices

25.8.2026 | Published in English on 26.8.2026 at 15.32

The transparency obligations laid down in Article 50 of the EU Artificial Intelligence Act (2024/1689) have been applied since 2 August 2026. The obligations apply to the providers and deployers of certain AI systems. The purpose of the obligations is to help people identify when they are interacting with an AI system and recognise content produced or manipulated by AI.

The AI Act’s transparency obligations also apply to the medical device sector

Transparency obligations also apply to AI systems used in the medical device sector. The application of the transparency obligations does not depend on whether or not an AI system is classified as high-risk. The obligations laid down in Article 50 may already apply to an AI system used in a medical device if the system has one of the functionalities or uses referred to in Article 50.

AI Omnibus alters timeline for application to high-risk AI systems

The Digital Omnibus on AI (EU) 2026/1744 (AI Omnibus) changed the timeline for the application of the requirements for high-risk AI systems. The application of the rules on high-risk AI systems in products referred to in Annex I to the AI Act will begin on 2 August 2028. The amendment also applies to medical devices when an AI system contained in them meets the conditions for being high risk laid down in Article 6 of the AI Act.

Fimea will update the website on the use of AI in medical devices as well as the timeline for the application of the regulation to correspond to the changed schedule.