--- title: "AI Act Transparency Obligations, Definition | MedTech Terms" description: "Article 50 requirements for specific AI systems, including disclosure that a user is interacting with AI and labelling of synthetic content." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ai-act-transparency-obligations#term", "name": "AI Act Transparency Obligations", "description": "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. 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[Home](/) 2. [Terms](/terms) 3. [Regulatory](/terms?cat=Regulatory) 4. AI Act Transparency Obligations [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[AI / ML in Devices](/ecosystems/ai-ml) # 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 Cyber](/authors/christian-espinosa) Last 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](/terms/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 Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory High-Risk AI System (EU AI Act) AI systems captured by Article 6 of the EU AI Act because they are safety components of regulated products or listed in Annex III. ](/terms/ai-act-high-risk-system) ### More in Regulatory · Same category [ Regulatory 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k)[ 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. ](/terms/510k-summary-vs-statement)[ 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. ](/terms/513g)[ Regulatory Abbreviated 510(k) 510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards. ](/terms/abbreviated-510k) Cited by Where this term appears across MedTech Terms. Ecosystems (2) - [Regulated Pathways](/ecosystems/regulated-pathways) - [AI / ML in Devices](/ecosystems/ai-ml) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 EUR-Lex· 1 FDA· 1 European Commission· 1 1. [1 Regulation (EU) 2024/1689, Article 50 Verified EUR-Lex eur-lex.europa.eu ](https://eur-lex.europa.eu/eli/reg/2024/1689/oj) 2. [2 FDA - Medical Devices Verified FDA fda.gov ](https://www.fda.gov/medical-devices) 3. [3 European Commission - Medical Devices Verified European Commission health.ec.europa.eu ](https://health.ec.europa.eu/medical-devices-sector_en) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Navigating an FDA or EU MDR submission? Blue Goat Cyber supports the cybersecurity content of premarket submissions, from threat models to the 524B narrative. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Regulatory Sources 3 Updated 7/25/2026 [Compare with another term](/compare?a=ai-act-transparency-obligations) Learn in 60 seconds Card Lesson Quiz Article 50 requirements for specific AI systems, including disclosure that a user is interacting with AI and labelling of synthetic content. - · This applies even when the device is not high-risk. - · Deployers of emotion-recognition or biometric-categorisation systems must inform exposed persons. Remember this Article 50 requirements for specific AI systems, including disclosure that a user is interacting with AI and labelling of synthetic content. Related terms - [High-Risk AI System (EU AI Act) ](/terms/ai-act-high-risk-system) You may also need Auto-suggested from Regulatory and shared keywords. - [Fundamental Rights Impact Assessment(FRIA) ](/terms/ai-act-fria) - [AI Act Technical Documentation (Annex IV) ](/terms/ai-act-technical-documentation) - [Genetic Testing Requirements (IVDR Article 4) ](/terms/ivdr-genetic-testing) - [Provider and Deployer (EU AI Act) ](/terms/ai-act-provider-deployer) - [AI Act Post-Market Monitoring ](/terms/ai-act-post-market-monitoring) - [Common Specifications (IVDR)(CS) ](/terms/ivdr-common-specifications) [All Regulatory terms](/terms?cat=Regulatory) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) - [ MedTech Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.com) - [ MedTech Launchpad MedTech funding rounds, accelerators, and launch resources. ](https://medtechlaunchguide.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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