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AI Act Transparency Obligations
Article 50 requirements for specific AI systems, including disclosure that a user is interacting with AI and labelling of synthetic content.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed July 25, 2026
Definition
Article 50 requires providers to design AI systems that interact with natural persons so that those persons are informed they are interacting with an AI, and that synthetic audio, image, video, or text output is marked as artificially generated or manipulated in a machine-readable format. Deployers of emotion-recognition or biometric-categorisation systems must inform exposed persons.What this means in practice
Digital therapeutics and clinical chat interfaces should surface an explicit AI disclosure and, where they generate synthetic content (for example patient education videos), meet the labelling requirement. This applies even when the device is not high-risk.Related terms
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510(k) Premarket Notification(510(k))
FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
Regulatory
510(k) Summary vs 510(k) Statement
Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request.
Regulatory
513(g) Request for Information(513(g))
Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.
Regulatory
Abbreviated 510(k)
510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.
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Ecosystems (2)
Primary references
3 sourcesLink health: 3 verified· last checked 2026-06-20
EUR-Lex·1FDA·1European Commission·1
- 1
Regulation (EU) 2024/1689, Article 50VerifiedEUR-Lexeur-lex.europa.eu
- 2
FDA - Medical DevicesVerifiedFDAfda.gov
- 3
European Commission - Medical DevicesVerifiedEuropean Commissionhealth.ec.europa.eu
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