Case 03: Medical Diagnostic AI
Medical Diagnostic AI: is it legal in the EU, the United States and China?
The system on trial: AI-driven diagnostic device. The same product meets three legal realities. Each verdict below is an editorial summary of the instruments cited under it, so every claim can be checked against the official text in one click.
EU: HEAVILY REGULATED. US: HEAVILY REGULATED. CN: LICENSED: FILING REQUIRED
Medical Diagnostic AI: how does the European Union treat it?
HEAVILY REGULATED. Automatic high-risk via the device route. AI needing third-party conformity assessment under the MDR/IVDR is automatically high-risk (Art. 6(1) + Annex I): one integrated CE/Notified-Body route. AI-Act application is deferred to 2 Aug 2028; the MDR itself fully applies today.
HEAVILY REGULATED means: Legal, but gated by conformity, licensing, oversight and documentation duties.
Source: Art. 6(1): AI Act: device-route high-risk; Reg. 2026/1744: Digital Omnibus on AI
Medical Diagnostic AI: how does the United States treat it?
HEAVILY REGULATED. The FDA is America's most mature AI regulator. Full premarket review (510(k)/De Novo/PMA) with lifecycle and bias expectations; 1,247+ AI devices authorized, roughly 76 to 80% in radiology. PCCP guidance lets models update pre-authorized.
HEAVILY REGULATED means: Legal, but gated by conformity, licensing, oversight and documentation duties.
Source: FDA: FDA AI-Enabled Medical Devices; PCCP 2024: FDA Predetermined Change Control Plans
Medical Diagnostic AI: how does China treat it?
LICENSED: FILING REQUIRED. NMPA device registration, typically Class III. Pre-market registration, clinical validation and lifecycle oversight; the first AI diagnostic was approved in 2020, with 50+ deep-learning devices on the market by 2023.
LICENSED: FILING REQUIRED means: Must register with the state and pass review before launch.
Source: NMPA: NMPA medical device registration; S30: Chambers Healthcare AI 2025: China
The trapdoor
A hospital-facing GenAI chatbot additionally triggers a CAC GenAI filing: device registration alone isn't enough.
The other 5 cases on the board
- AI Hiring Tool: legal in the EU, the US and China?CV screening & candidate ranking. EU: HEAVILY REGULATED. US: HEAVILY REGULATED. CN: MOSTLY UNREGULATED.
- LLM Chatbot: legal in the EU, the US and China?general-purpose customer service. EU: TRANSPARENCY DUTY. US: LIGHT-TOUCH. CN: LICENSED: FILING REQUIRED.
- Deepfake Generator: legal in the EU, the US and China?synthetic media tool. EU: TRANSPARENCY DUTY. US: LIGHT-TOUCH. CN: HEAVILY REGULATED.
- Credit Scoring AI: legal in the EU, the US and China?automated creditworthiness. EU: HEAVILY REGULATED. US: HEAVILY REGULATED. CN: HEAVILY REGULATED.
- Police Live Facial Recognition: legal in the EU, the US and China?real-time biometric ID in public. EU: PROHIBITED. US: MOSTLY UNREGULATED. CN: HEAVILY REGULATED.
Read the regimes behind these verdicts
- The three regime dossiers explain why European Union, United States and China reach different answers about the same product.
- The Framework Explorer holds every instrument cited on this page, each with its own page, status, provisions and sources.
- Open this case on the interactive board to see the three stamps land side by side.
- The EU AI Act Explorer serves the text of Regulation (EU) 2024/1689 itself, one page per provision.
Knowing the verdict is step one. Passing the assessment is the job.
The programs teach the work that follows: classification calls, conformity assessment, filings, documentation, and the judgment to defend every decision.
VERIFIED 29 JUL 2026. The verdicts are editorial summaries of the instruments cited above, not rulings. Study aid, not legal advice: the official texts are always authoritative.