All terms
AI Act Prohibited Practices
Article 5 practices banned outright in the EU, including subliminal manipulation and untargeted facial-recognition scraping.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed July 25, 2026
Definition
Article 5 lists AI practices that are prohibited in the Union, including subliminal or manipulative techniques causing significant harm, exploitation of vulnerabilities, social scoring by public authorities, real-time remote biometric identification in public spaces for law enforcement (with narrow exceptions), untargeted scraping of facial images to build databases, emotion inference at work or school (with medical and safety exceptions), and biometric categorisation inferring sensitive attributes.What this means in practice
Most MedTech products sit well outside these categories, but emotion-inference features in workplace-wellness or education-adjacent digital health products can trigger the prohibition. The medical-purposes exception is narrow: it applies when emotion inference is genuinely part of a medical device's intended purpose, not a marketing add-on.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.
Cited by
Where this term appears across MedTech Terms.
Ecosystems (3)
Primary references
3 sourcesLink health: 3 verified· last checked 2026-06-20
EUR-Lex·1European Commission·1IMDRF·1
- 1
Regulation (EU) 2024/1689, Article 5VerifiedEUR-Lexeur-lex.europa.eu
- 2
European Commission - Medical DevicesVerifiedEuropean Commissionhealth.ec.europa.eu
- 3
IMDRF DocumentsVerifiedIMDRFimdrf.org
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