AI law comparison · Data verified 2026-08-22
EU AI Act vs EU AI Act — Medical Device AI
EU AI Act and EU AI Act — Medical Device AI 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 tracks 10 compliance requirements and EU AI Act — Medical Device AI tracks 3. 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 Artificial Intelligence Act
Regulation (EU) 2024/1689 — the world's first comprehensive AI law. Classifies AI systems by risk: prohibited (social scoring, subliminal manipulation), high-risk (Annex III: HR, credit, education, critical infrastructure, law enforcement), limited-risk (transparency obligations for chatbots and deepfakes), minimal-risk (most AI tools). Providers AND deployers have obligations. Extraterritorial: applies when the AI s…
Full EU AI Act requirementsEU 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 requirementsCommon questions
Could both EU AI Act and EU AI Act — Medical Device AI apply to my business?
Yes. EU AI Act and EU AI Act — Medical Device AI are separate regulations with separate scopes — a business can fall under both at once. EU AI Act covers Applies to: (1) providers placing AI systems on EU market or putting into service, (2) deployers using AI systems within EU, (3) providers/deployers in third co… 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… 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 or EU AI Act — Medical Device AI?
EU AI Act: €35,000,000 or 7% of global annual turnover (whichever higher) for prohibited AI; €15M or 3% for high-risk violations; €7.5M or 1% for incorrect information to authorities EU AI Act — Medical Device AI: €15,000,000 or 3% of global annual turnover for high-risk AI violations 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 — effective 2024-08-01, enforcement from 2026-08-02. EU AI Act — Medical Device AI — effective 2024-08-01, enforcement from 2028-08-02. Dates last verified against official sources on 2026-08-22 and 2026-08-22 respectively.
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