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Latest / Health and life sciences

Rule changeHealthGovernmentFrontierEUConfirmed

EU AI Act published in the Official Journal, with AI medical devices classed high-risk

See how this story connects

Source: EUR-Lex: Regulation (EU) 2024/1689

Regulation (EU) 2024/1689, the AI Act, was published in the Official Journal on 12 July 2024 and entered into force 20 days later. AI systems that are, or are safety components of, medical devices needing third-party conformity assessment under the Medical Devices and In Vitro Diagnostics Regulations are high-risk, with those obligations applying from 2 August 2027. Emergency patient-triage systems and AI used to price health and life insurance are also listed as high-risk.

Why it matters

Makers of AI medical devices sold in the EU faced AI Act duties on data, documentation and human oversight on top of device certification, due from August 2027.

When
12 Jul 2024
ID
WTA-N-2024-0011
Who
European Parliament, Council of the EU, European Commission
Rules involved

Summary by wheresthe.ai, from EUR-Lex. Checked against the source on 9 Oct 2026.

Read the original at EUR-Lex

Source copy: download the page as saved on 18 Oct 2026 (PDF). Also held by the Internet Archive.

Next stop on this Storyline: Led toEU deal keeps AI medical devices under AI Act high-risk rules, delayed to 2028

Cite this story

WTA-N-2024-0011: “EU AI Act published in the Official Journal, with AI medical devices classed high-risk.” wheresthe.ai, 12 Jul 2024. https://wheresthe.ai/d/eu-ai-act-medical-devices-high-risk-2024-07/ (source: EUR-Lex: Regulation (EU) 2024/1689).

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