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Article 43 — Conformity assessment

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

Before a high-risk system reaches the market, its provider must complete a conformity assessment demonstrating compliance. Most Annex III systems qualify through internal control, but a notified body must be involved where harmonised standards are missing or only partly applied. Substantial modification triggers a fresh assessment, although changes a provider pre-defined and documented at the original assessment, including planned post-market learning, do not count as substantial. Systems tied to Annex I products follow that sectoral law's procedure instead.

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 →Harmonised standards →Compliance timeline →
PENALTY EXPOSURE
€15M or 3%
of worldwide turnover — see Art. 99 penalties framework.
← PREVIOUS · ART. 42 Presumption of conformity with certain requirements NEXT · ART. 44 → Certificates
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