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Article 16 — Obligations of providers of high-risk AI systems

APPLIES DEC 2, 2027 WAS 2026-08-02 AMENDED BY OMNIBUS
Chapter III · High-risk tier
Source: EUR-Lex · CELEX 32024R1689
Verified 2026-07-16
PLAIN-LANGUAGE SUMMARY — ORIGINAL INTERPRETATION, NOT THE OFFICIAL TEXT

Providers of high-risk AI systems carry the core compliance burden. They must meet the Section 2 requirements, mark their identity and contact details on the system, run a quality management system, retain documentation and logs, and complete conformity assessment before release. They also draw up the EU declaration of conformity, affix the CE marking, register the system, and take corrective action when needed. On a reasoned request they must demonstrate conformity, and accessibility duties apply.

AMENDED BY THE DIGITAL OMNIBUS ON AI

This provision's application date moved under the Omnibus. It now applies from 2027-12-02 (originally 2026-08-02). Source: Omnibus final text (OJ pending) · verified 2026-07-16

OFFICIAL TEXT Read verbatim on EUR-Lex ↗
The authoritative wording lives on EUR-Lex, quoted there in all 24 languages. We deep-link to the paragraph level rather than reproducing the full text. The consolidated post-Omnibus version will be linked the day its CELEX publishes.
AT A GLANCE
Chapter: III — High-risk AI systems
Applies: Dec 2, 2027
Tier: High-risk tier
RELATED
Provider obligations →Read the full article →Enforcement & penalties →
PENALTY EXPOSURE
€15M or 3%
of worldwide turnover — see Art. 99 penalties framework.
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ELSEWHERE IN CHAPTER III — High-risk AI systems
Art. 6 Classification rules for high-risk AI systems Art. 7 Amendments to Annex III Art. 8 Compliance with the requirements Art. 9 Risk management system Art. 10 Data and data governance Art. 11 Technical documentation Art. 12 Record-keeping Art. 13 Transparency and provision of information to d