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Table of contents

Chapter I: General Provisions

Article 1: Subject Matter

Article 2: Scope

Article 3: Definitions

Article 4: AI literacy

Chapter II: Prohibited AI Practices

Article 5: Prohibited AI Practices

Chapter III: High-Risk AI System

Section 1: Classification of AI Systems as High-Risk

Article 6: Classification Rules for High-Risk AI Systems

Article 7: Amendments to Annex III

Section 2: Requirements for High-Risk AI Systems

Article 8: Compliance with the Requirements

Article 9: Risk Management System

Article 10: Data and Data Governance

Article 11: Technical Documentation

Article 12: Record-Keeping

Article 13: Transparency and Provision of Information to Deployers

Article 14: Human Oversight

Article 15: Accuracy, Robustness and Cybersecurity

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 18: Documentation Keeping

Article 19: Automatically Generated Logs

Article 20: Corrective Actions and Duty of Information

Article 21: Cooperation with Competent Authorities

Article 22: Authorised Representatives of Providers of High-Risk AI Systems

Article 23: Obligations of Importers

Article 24: Obligations of Distributors

Article 25: Responsibilities Along the AI Value Chain

Article 26: Obligations of Deployers of High-Risk AI Systems

Article 27: Fundamental Rights Impact Assessment for High-Risk AI Systems

Section 4: Notifying Authorities and Notified Bodies

Article 28: Notifying Authorities

Article 29: Application of a Conformity Assessment Body for Notification

Article 30: Notification Procedure

Article 31: Requirements Relating to Notified Bodies

Article 32: Presumption of Conformity with Requirements Relating to Notified Bodies

Article 33: Subsidiaries of Notified Bodies and Subcontracting

Article 34: Operational Obligations of Notified Bodies

Article 35: Identification Numbers and Lists of Notified Bodies

Article 36: Changes to Notifications

Article 37: Challenge to the Competence of Notified Bodies

Article 38: Coordination of Notified Bodies

Article 39: Conformity Assessment Bodies of Third Countries

Section 5: Standards, Conformity Assessment, Certificates, Registration

Article 40: Harmonised Standards and Standardisation Deliverables

Article 41: Common Specifications

Article 42: Presumption of Conformity with Certain Requirements

Article 43: Conformity Assessment

Article 44: Certificates

Article 45: Information Obligations of Notified Bodies

Article 46: Derogation from Conformity Assessment Procedure

Article 47: EU Declaration of Conformity

Article 48: CE Marking

Article 49: Registration

Chapter IV: Transparency Obligations for Providers and Deployers of Certain AI Systems

Article 50: Transparency Obligations for Providers and Deployers of Certain AI Systems

Chapter V: General-Purpose AI Models

Section 1: Classification Rules

Article 51: Classification of General-Purpose AI Models as General-Purpose AI Models with Systemic Risk

Article 52: Procedure

Section 2: Obligations for Providers of General-Purpose AI Models

Article 53: Obligations for Providers of General-Purpose AI Models

Article 54: Authorised Representatives of Providers of General-Purpose AI Models

Section 3: Obligations of Providers of General-Purpose AI Models with Systemic Risk

Article 55: Obligations for Providers of General-Purpose AI Models with Systemic Risk

Section 4: Codes of Practice

Article 56: Codes of Practice

Chapter VI: Measures in Support of Innovation

Article 57: AI Regulatory Sandboxes

Article 58: Detailed Arrangements for, and Functioning of, AI Regulatory Sandboxes

Article 59: Further Processing of Personal Data for Developing Certain AI Systems in the Public Interest in the AI Regulatory Sandbox

Article 60: Testing of High-Risk AI Systems in Real World Conditions Outside AI Regulatory Sandboxes

Article 61: Informed Consent to Participate in Testing in Real World Conditions Outside AI Regulatory Sandboxes

Article 62: Measures for Providers and Deployers, in Particular SMEs, Including Start-Ups

Article 63: Derogations for Specific Operators

Chapter VII: Governance

Section 1: Governance at Union Level

Article 64: AI Office

Article 65: Establishment and Structure of the European Artificial Intelligence Board

Article 66: Tasks of the Board

Article 67: Advisory Forum

Article 68: Scientific Panel of Independent Experts

Article 69: Access to the Pool of Experts by the Member States

Section 2: National Competent Authorities

Article 70: Designation of National Competent Authorities and Single Point of Contact

Chapter VIII: EU Database for High-Risk AI Systems

Article 71: EU Database for High-Risk AI Systems Listed in Annex III

Chapter IX: Post-Market Monitoring, Information Sharing and Market Surveillance

Section 1: Post-Market Monitoring

Article 72: Post-Market Monitoring by Providers and Post-Market Monitoring Plan for High-Risk AI Systems

Section 2: Sharing of Information on Serious Incidents

Article 73: Reporting of Serious Incidents

Section 3: Enforcement

Article 74: Market Surveillance and Control of AI Systems in the Union Market

Article 75: Mutual Assistance, Market Surveillance and Control of General-Purpose AI Systems

Article 76: Supervision of Testing in Real World Conditions by Market Surveillance Authorities

Article 77: Powers of Authorities Protecting Fundamental Rights

Article 78: Confidentiality

Article 79: Procedure at National Level for Dealing with AI Systems Presenting a Risk

Article 80: Procedure for Dealing with AI Systems Classified by the Provider as Non-High-Risk in Application of Annex III

Article 81: Union Safeguard Procedure

Article 82: Compliant AI Systems Which Present a Risk

Article 83: Formal Non-Compliance

Article 84: Union AI Testing Support Structures

Section 4: Remedies

Article 85: Right to Lodge a Complaint with a Market Surveillance Authority

Article 86: Right to Explanation of Individual Decision-Making

Article 87: Reporting of Infringements and Protection of Reporting Persons

Section 5: Supervision, Investigation, Enforcement and Monitoring in Respect of Providers of General-Purpose AI Models

Article 88: Enforcement of the Obligations of Providers of General-Purpose AI Models

Article 89 : Monitoring Actions

Article 90: Alerts of Systemic Risks by the Scientific Panel

Article 91: Power to Request Documentation and Information

Article 92: Power to Conduct Evaluations

Article 93: Power to Request Measures

Article 94: Procedural Rights of Economic Operators of the General-Purpose AI Model

Chapter X: Codes of Conduct and Guidelines

Article 95: Codes of Conduct for Voluntary Application of Specific Requirements

Article 96: Guidelines from the Commission on the Implementation of this Regulation

Chapter XI: Delegation of Power and Committee Procedure

Article 97: Exercise of the Delegation

Article 98: Committee Procedure

Chapter XII: Penalties

Article 99: Penalties

Article 100: Administrative Fines on Union Institutions, Bodies, Offices and Agencies

Article 101: Fines for Providers of General-Purpose AI Models

Chapter XIII: Final Provisions

Article 102: Amendment to Regulation (EC) No 300/2008

Article 103: Amendment to Regulation (EU) No 167/2013

Article 104: Amendment to Regulation (EU) No 168/2013

Article 105: Amendment to Directive 2014/90/EU

Article 106: Amendment to Directive (EU) 2016/797

Article 107: Amendment to Regulation (EU) 2018/858

Article 108: Amendments to Regulation (EU) 2018/1139

Article 109: Amendment to Regulation (EU) 2019/2144

Article 110: Amendment to Directive (EU) 2020/1828

Article 111: AI Systems Already Placed on the Market or put into Service and General-Purpose AI Models Already Placed on the Marked

Article 112: Evaluation and Review

Article 113: Entry into Force and Application

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Annexes

Annex I: List of Union Harmonisation Legislation

Annex II: List of Criminal Offences Referred to in Article 5(1), First Subparagraph, Point (h)(iii)

Annex III: High-Risk AI Systems Referred to in Article 6(2)

Annex IV: Technical Documentation Referred to in Article 11(1)

Annex V: EU Declaration of Conformity

Annex VI: Conformity Assessment Procedure Based on Internal Control

Annex VII: Conformity Based on Assessment of the Quality Management System and an Assessment of the Technical Documentation

Annex VIII: Information to be Submitted upon the Registration of High-Risk AI Systems in Accordance with Article 49

Annex IX: Information to be Submitted upon the Registration of High-Risk AI Systems Listed in Annex III in Relation to Testing in Real World Conditions in Accordance with Article 60

Annex X: Union Legislative Acts on Large-Scale IT Systems in the Area of Freedom, Security and Justice

Annex XI: Technical Documentation Referred to in Article 53(1), Point (a) - Technical Documentation for Providers of General-Purpose AI Models

Annex XII: Transparency Information Referred to in Article 53(1), Point (b) - Technical Documentation for Providers of General-Purpose AI Models to Downstream Providers that Integrate the Model into Their AI System

Annex XIII: Criteria for the Designation of General-Purpose AI models with Systemic Risk Referred to in Article 51

Search within the Act

Part of Chapter XIII: Final Provisions

Article 108: Amendments to Regulation (EU) 2018/1139

Date of entry into force:

2 August 2026

According to:

Article 113

See here for a full implementation timeline.

Summary

The EU has made changes to its 2018 regulation on artificial intelligence (AI). These changes mean that when new rules are being made about AI systems that are used for safety, the requirements in a specific section of another regulation (Regulation (EU) 2024/…) must be considered. This applies to both implementing acts (rules that help enforce laws) and delegated acts (rules that are made by someone given authority by the original law-maker). The changes affect several articles (sections) of the 2018 regulation.

Generated by CLaiRK, edited by us.

NOTE: This translation is a machine-generated translation. It is not the official translation provided by the European Parliament. When the AI Act is published in the official journal, the machine-generated translations will be replaced by the official translations.

Regulation (EU) 2018/1139 is amended as follows:

(1) in Article 17, the following paragraph is added:

‘3. Without prejudice to paragraph 2, when adopting implementing acts pursuant to paragraph 1 concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council[*], the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.’

(2) in Article 19, the following paragraph is added:

‘4. When adopting delegated acts pursuant to paragraphs 1 and 2 concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.’

(3) in Article 43, the following paragraph is added:

‘4. When adopting implementing acts pursuant to paragraph 1 concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.’

(4) in Article 47, the following paragraph is added:

‘3. When adopting delegated acts pursuant to paragraphs 1 and 2 concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.’

(5) in Article 57, the following subparagraph is added:

‘When adopting those implementing acts concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.’

(6) in Article 58, the following paragraph is added:

‘3. When adopting delegated acts pursuant to paragraphs 1 and 2 concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.’

[*] 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) (OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1689/oj)

Suitable Recitals

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View the official text, or browse it online using our AI Act Explorer. The text used in this tool is the ‘Artificial Intelligence Act (Regulation (EU) 2024/1689), Official Journal version of 13 June 2024’. Interinstitutional File: 2021/0106(COD)