Article 11 — Technical documentation
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
Source: EUR-Lex · CELEX 32024R1689
Verified 2026-07-16
PLAIN-LANGUAGE SUMMARY — ORIGINAL INTERPRETATION, NOT THE OFFICIAL TEXT
Providers of high-risk AI systems must prepare technical documentation before the system reaches the market and keep it current. It must show that the system meets the section's requirements and give authorities and notified bodies clear information to assess compliance, covering at least the elements set out in Annex IV. Smaller firms and start-ups may use a simplified form, which notified bodies must accept. The Commission may update the required contents as technology advances.
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
AT A GLANCE
Chapter: III — High-risk AI systems
Applies: Dec 2, 2027
Tier: High-risk tier
PENALTY EXPOSURE
€15M or 3%
of worldwide turnover — see Art. 99 penalties framework.
ELSEWHERE IN CHAPTER III — High-risk AI systems