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Article 45 — Information obligations of notified bodies

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

Notified bodies must keep authorities and one another informed about their conformity work. They report issued, refused, restricted, suspended or withdrawn certificates and quality-system approvals to the notifying authority, and share results — especially negative ones — with peer bodies handling similar systems. They also disclose information requests received from market surveillance authorities. Everything shared remains subject to confidentiality safeguards.

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

Conformity and standards →Notified bodies →Guidance →

PENALTY EXPOSURE

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of worldwide turnover — see Art. 99 penalties framework.

← PREVIOUS · ART. 44 Certificates NEXT · ART. 46 → Derogation from conformity assessment procedure

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