TamRx · Medical AI compliance

Is my AI high-risk under the EU AI Act?

If your AI is a CE-marked medical device regulated under MDR or IVDR with Notified Body involvement, it is automatically high-risk under the EU AI Act — there is no separate AI risk-classification step. What matters then is which obligations apply, and by when.

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Automatic high-risk classification

Any AI system that is itself a medical device, or a safety component of one, regulated under MDR or IVDR and requiring third-party conformity assessment, is automatically high-risk. A Class IIa diagnostic imaging AI, a Class III decision-support algorithm and a Class C IVD with an AI interpretation engine are all high-risk. Rule-based software with no learning component is not covered by the AI Act.

What high-risk actually requires

High-risk obligations span Articles 9–15: a risk management system, data governance, technical documentation, automatic logging, transparency to users, human oversight, and accuracy/robustness/cybersecurity. For MDR-compliant teams, data governance (Article 10) and logging (Article 12) are usually the widest genuine gaps.

The deadlines moved — know which applies

The original high-risk dates were 2 August 2026 and 2 August 2027. Under the Digital Omnibus, the date for AI embedded in regulated products like medical devices moved to 2 August 2028 — but the change is not yet law until formally published. The AI literacy obligation (Article 4) stays fixed at 2 August 2026. Run the live assessment for the exact current position.

Frequently asked questions

Is all medical AI high-risk under the EU AI Act?

Effectively yes for AI that is a medical device or safety component regulated under MDR/IVDR with Notified Body involvement — it is automatically high-risk. AI with no learning component, or with no medical device status, may fall outside or into a lower-risk category.

When do EU AI Act obligations start for medical devices?

The original date was 2 August 2027 for AI in regulated products; the Digital Omnibus moves this to 2 August 2028, but only once formally adopted. Until then, 2 August 2026 remains an active baseline and AI literacy (Article 4) applies from 2 August 2026 regardless.

Does MDR compliance mean I already meet the AI Act?

No. They are parallel frameworks. MDR governs safety and performance; the AI Act governs how the AI was built, trained and governed. Risk management and documentation partly reuse MDR work, but data governance, logging and AI literacy are typically new.

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Decision-support only. AI-generated content may contain errors. Not legal or medical advice, and no guarantee of regulatory approval. Verify against primary legislation, guidance and qualified professional judgement before submission.