+CHAPTER III HIGH-RISK AI SYSTEMS
---+SECTION 1 Classification of AI systems as high-risk
------+Article 6 Classification rules for high-risk AI systems
---------+Article 6 1.
---------+Article 6 1a.
---------+Article 6 1b.
---------+Article 6 1c.
---------+Article 6 2.
---------+Article 6 3.
---------+Article 6 4.
---------+Article 6 5.
---------+Article 6 6.
---------+Article 6 7.
---------+Article 6 8.
------+Article 7 Amendments to Annex III
---------+Article 7 1.
---------+Article 7 2.
---------+Article 7 3.
---+SECTION 2 Requirements for high-risk AI systems
------+Article 8 Compliance with the requirements
---------+Article 8 1.
---------+Article 8 2.
------+Article 9 Risk management system
---------+Article 9 1.
---------+Article 9 2.
---------+Article 9 3.
---------+Article 9 4.
---------+Article 9 5.
---------+Article 9 6.
---------+Article 9 7.
---------+Article 9 8.
---------+Article 9 9.
---------+Article 9 10.
------+Article 10 Data and data governance
---------+Article 10 1.
---------+Article 10 2.
---------+Article 10 3.
---------+Article 10 4.
---------+Article 10 6.
------+Article 11 Technical documentation
---------+Article 11 1.
---------+Article 11 2.
---------+Article 11 3.
------+Article 12 Record-keeping
---------+Article 12 1.
---------+Article 12 2.
---------+Article 12 3.
------+Article 13 Transparency and provision of information to deployers
---------+Article 13 1.
---------+Article 13 2.
---------+Article 13 3.
------+Article 14 Human oversight
---------+Article 14 1.
---------+Article 14 2.
---------+Article 14 3.
---------+Article 14 4.
---------+Article 14 5.
------+Article 15 Accuracy, robustness and cybersecurity
---------+Article 15 1.
---------+Article 15 2.
---------+Article 15 3.
---------+Article 15 4.
---------+Article 15 5.
---+SECTION 3 Obligations of providers and deployers of high-risk AI systems and other parties
------+Article 16 Obligations of providers of high-risk AI systems
------+Article 17 Quality management system
---------+Article 17 1.
---------+Article 17 2.
---------+Article 17 3.
---------+Article 17 4.
------+Article 18 Documentation keeping
---------+Article 18 1.
---------+Article 18 2.
---------+Article 18 3.
------+Article 19 Automatically generated logs
---------+Article 19 1.
---------+Article 19 2.
------+Article 20 Corrective actions and duty of information
---------+Article 20 1.
---------+Article 20 2.
------+Article 21 Cooperation with competent authorities
---------+Article 21 1.
---------+Article 21 2.
---------+Article 21 3.
------+Article 22 Authorised representatives of providers of high-risk AI systems
---------+Article 22 1.
---------+Article 22 2.
---------+Article 22 3.
---------+Article 22 4.
------+Article 23 Obligations of importers
---------+Article 23 1.
---------+Article 23 2.
---------+Article 23 3.
---------+Article 23 4.
---------+Article 23 5.
---------+Article 23 6.
---------+Article 23 7.
------+Article 24 Obligations of distributors
---------+Article 24 1.
---------+Article 24 2.
---------+Article 24 3.
---------+Article 24 4.
---------+Article 24 5.
---------+Article 24 6.
------+Article 25 Responsibilities along the AI value chain
---------+Article 25 1.
---------+Article 25 2.
---------+Article 25 3.
---------+Article 25 4.
---------+Article 25 5.
------+Article 26 Obligations of deployers of high-risk AI systems
---------+Article 26 1.
---------+Article 26 2.
---------+Article 26 3.
---------+Article 26 4.
---------+Article 26 5.
---------+Article 26 6.
---------+Article 26 7.
---------+Article 26 8.
---------+Article 26 9.
---------+Article 26 10.
---------+Article 26 11.
---------+Article 26 12.
------+Article 27 Fundamental rights impact assessment for high-risk AI systems
---------+Article 27 1.
---------+Article 27 2.
---------+Article 27 3.
---------+Article 27 4.
---------+Article 27 5.
---+SECTION 4 Notifying authorities and notified bodies
------+Article 28 Notifying authorities
---------+Article 28 1.
---------+Article 28 2.
---------+Article 28 3.
---------+Article 28 4.
---------+Article 28 5.
---------+Article 28 6.
---------+Article 28 7.
---------+Article 28 8.
---------+Article 28 9.
------+Article 29 Application of a conformity assessment body for notification
---------+Article 29 1.
---------+Article 29 2.
---------+Article 29 3.
---------+Article 29 4.
------+Article 30 Notification procedure
---------+Article 30 1.
---------+Article 30 2.
---------+Article 30 3.
---------+Article 30 4.
---------+Article 30 5.
------+Article 31 Requirements relating to notified bodies
---------+Article 31 1.
---------+Article 31 2.
---------+Article 31 3.
---------+Article 31 4.
---------+Article 31 5.
---------+Article 31 6.
---------+Article 31 7.
---------+Article 31 8.
---------+Article 31 9.
---------+Article 31 10.
---------+Article 31 11.
---------+Article 31 12.
------+Article 32 Presumption of conformity with requirements relating to notified bodies
------+Article 33 Subsidiaries of notified bodies and subcontracting
---------+Article 33 1.
---------+Article 33 2.
---------+Article 33 3.
---------+Article 33 4.
------+Article 34 Operational obligations of notified bodies
---------+Article 34 1.
---------+Article 34 2.
---------+Article 34 3.
------+Article 35 Identification numbers and lists of notified bodies
---------+Article 35 1.
---------+Article 35 2.
------+Article 36 Changes to notifications
---------+Article 36 1.
---------+Article 36 2.
---------+Article 36 3.
---------+Article 36 4.
---------+Article 36 5.
---------+Article 36 6.
---------+Article 36 7.
---------+Article 36 8.
---------+Article 36 9.
------+Article 37 Challenge to the competence of notified bodies
---------+Article 37 1.
---------+Article 37 2.
---------+Article 37 3.
---------+Article 37 4.
------+Article 38 Coordination of notified bodies
---------+Article 38 1.
---------+Article 38 2.
---------+Article 38 3.
------+Article 39 Conformity assessment bodies of third countries
---+SECTION 5 Standards, conformity assessment, certificates, registration
------+Article 40 Harmonised standards and standardisation deliverables
---------+Article 40 1.
---------+Article 40 2.
---------+Article 40 3.
------+Article 41 Common specifications
---------+Article 41 1.
---------+Article 41 2.
---------+Article 41 3.
---------+Article 41 4.
---------+Article 41 5.
---------+Article 41 6.
------+Article 42 Presumption of conformity with certain requirements
---------+Article 42 1.
---------+Article 42 2.
---------+Article 42 3.
------+Article 43 Conformity assessment
---------+Article 43 1.
---------+Article 43 2.
---------+Article 43 3.
---------+Article 43 4.
---------+Article 43 5.
---------+Article 43 6.
------+Article 44 Certificates
---------+Article 44 1.
---------+Article 44 2.
---------+Article 44 3.
------+Article 45 Information obligations of notified bodies
---------+Article 45 1.
---------+Article 45 2.
---------+Article 45 3.
---------+Article 45 4.
------+Article 46 Derogation from conformity assessment procedure
---------+Article 46 1.
---------+Article 46 2.
---------+Article 46 3.
---------+Article 46 4.
---------+Article 46 5.
---------+Article 46 6.
---------+Article 46 7.
------+Article 47 EU declaration of conformity
---------+Article 47 1.
---------+Article 47 2.
---------+Article 47 3.
---------+Article 47 4.
---------+Article 47 5.
------+Article 48 CE marking
---------+Article 48 1.
---------+Article 48 2.
---------+Article 48 3.
---------+Article 48 4.
---------+Article 48 5.
------+Article 49 Registration
---------+Article 49 1.
---------+Article 49 2.
---------+Article 49 3.
---------+Article 49 4.
---------+Article 49 5.

CHAPTER III HIGH-RISK AI SYSTEMS

CHAPTER III HIGH-RISK AI SYSTEMS

1. Overview

,
SECTION 1 Classification of AI systems as high-risk SECTION 1 Classification of AI systems as high-risk
SECTION 2 Requirements for high-risk AI systems SECTION 2 Requirements for high-risk AI systems
SECTION 3 Obligations of providers and deployers of high-risk AI systems and other parties SECTION 3 Obligations of providers and deployers of high-risk AI systems and other parties
SECTION 4 Notifying authorities and notified bodies SECTION 4 Notifying authorities and notified bodies
SECTION 5 Standards, conformity assessment, certificates, registration SECTION 5 Standards, conformity assessment, certificates, registration

1.1 References

1.2 Identified Requirements

1.3 Related Standards

2. Identified Requirements

Requirements

3. Related Standards

Standards

Linked Issues

Issuelinks
is part of REGULATION (EU) 2024/1689 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (Text with EEA relevance)
  • Builddate: 27.07.2026 00:00:00 -Doknr: CELEX:32024R1689
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