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EU Regulation · AI Act

EU Artificial Intelligence Act

Regulation (EU) 2024/1689

The EU Artificial Intelligence Act regulates AI systems by risk tier, from prohibited practices to high-risk obligations. Hardware that embeds AI inference or decision-making may fall in scope alongside its other product regulations.

What it covers

Products that incorporate AI systems — inference, decision-making or generative capabilities.

How it applies to your product

The AI Act sorts AI systems into risk tiers — a small set of prohibited practices, a set of high-risk uses carrying conformity obligations, and lighter transparency duties for the rest. For hardware that embeds AI it stacks on top of the product’s existing regulations rather than replacing them, so an AI-enabled device can fall under both the AI Act and, say, the Machinery Regulation or the MDR.

Key dates

High-risk Annex III: 2 December 2027; Annex I product high-risk: 2 August 2028 under 2026/1744. Other obligations have separate dates.

Authoritative source

Always confirm against the primary text on EUR-Lex — the official EU legal database.

Read Regulation (EU) 2024/1689 on EUR-Lex ↗

Guides on AI Act

From the Library

  • guide

    CE marking AI-enabled hardware — CRA + AI Act overlap

    A scope overview for AI-enabled hardware: updated high-risk application dates, category-specific assessment, and evidence needed alongside product legislation.

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