Home / The Act / Chapter III / Article 46

Article 46 — Derogation from conformity assessment procedure

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

As an exception, a market surveillance authority may allow a specific high-risk system onto the market before its conformity assessment finishes — on justified grounds such as public security or health, temporarily, and only if it finds the system already meets the Act’s substantive requirements. In urgency, law-enforcement or civil-protection bodies may deploy first and seek authorisation after. Member States or the Commission may object within 15 days; the Commission alone decides.

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
Market surveillance →Provider obligations →Guidance →
PENALTY EXPOSURE
—
of worldwide turnover — see Art. 99 penalties framework.
← PREVIOUS · ART. 45 Information obligations of notified bodies NEXT · ART. 47 → EU declaration of conformity
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