AI law comparison · Data verified 2026-08-22
EU AI Act — Medical Device AI vs EU AI Act — Prohibited Practices
EU AI Act — Medical Device AI and EU AI Act — Prohibited Practices are two of the 169 AI and data regulations Aegis Firma tracks. They have different scopes, effective dates, and penalties — and many businesses fall under both. Here is the side-by-side, drawn directly from the regulatory registry.
Find which laws apply to my businessSide by side
Summary of publicly available regulatory text. Verify against current official sources before relying on this for compliance decisions. Not legal advice.
The key difference
EU AI Act — Medical Device AI takes effect first, so it is usually the more urgent of the two. EU AI Act — Medical Device AI tracks 3 compliance requirements and EU AI Act — Prohibited Practices tracks 4. They are not interchangeable — meeting one does not discharge the other. The practical question is not which law is “stricter,” but which of them — or both — actually applies to your business.
EU AI Act — High-Risk Medical Device AI (Article 6 / MDR / IVDR)
EU AI Act Article 6(1) classifies AI systems embedded in EU-regulated medical devices as high-risk. Any AI-powered medical device subject to third-party conformity assessment under MDR (Class IIa, IIb, III) or IVDR (Class B, C, D) must comply with the full EU AI Act high-risk regime by August 2, 2028 (DEFERRED from the original 2 Aug 2027 by the Digital Omnibus — Regulation (EU) 2026/1744, published in the Official J…
Full EU AI Act — Medical Device AI requirementsEU AI Act — Prohibited Practices (Article 5)
EU AI Act Article 5 bans eight categories of AI outright — no grace period, no exceptions. These prohibitions became enforceable February 2, 2025 and are subject to the HIGHEST penalties in the entire AI Act. Key bans: (1) Social scoring of individuals by public/private bodies. (2) AI systems exploiting vulnerabilities (age, disability, socioeconomic status) to manipulate behavior. (3) Subliminal AI techniques that d…
Full EU AI Act — Prohibited Practices requirementsCommon questions
Could both EU AI Act — Medical Device AI and EU AI Act — Prohibited Practices apply to my business?
Yes. EU AI Act — Medical Device AI and EU AI Act — Prohibited Practices are separate regulations with separate scopes — a business can fall under both at once. EU AI Act — Medical Device AI covers Applies to: providers (and, in their respective roles, deployers, importers, and distributors) of AI systems that are, or are a safety component of, a medical d… EU AI Act — Prohibited Practices covers Applies to: any provider, deployer, importer, or distributor that places on the EU market, puts into service, or uses an AI system in the EU that falls into one… If your operations meet both scopes, you must comply with both. Aegis Firma's free scan checks all 169 tracked regulations against your business profile so you do not have to read each law to find out.
Which has the higher maximum penalty — EU AI Act — Medical Device AI or EU AI Act — Prohibited Practices?
EU AI Act — Medical Device AI: €15,000,000 or 3% of global annual turnover for high-risk AI violations EU AI Act — Prohibited Practices: €35,000,000 or 7% of global annual turnover — highest penalty in the entire AI Act Penalty structures differ by regulator and violation type — read each law's full page for the cure periods and per-violation detail.
When does each law take effect?
EU AI Act — Medical Device AI — effective 2024-08-01, enforcement from 2028-08-02. EU AI Act — Prohibited Practices — effective 2025-02-02, enforcement from 2025-08-02. Dates last verified against official sources on 2026-08-22 and 2026-08-22 respectively.
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