Table of contents

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 and Subcontracting by Notified Bodies

Article 34: Operational Obligations of Notified Bodies

Article 35: Identification Numbers and Lists of Notified Bodies Designated Under this Regulation

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

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 for Dealing with AI Systems Presenting a Risk at National Level

Article 80: Procedure for Dealing with AI Systems Classified by the Provider as a Not 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: A Right to Explanation of Individual Decision-Making

Article 87: Reporting of Breaches 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 Obligations on 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

Recitals

Annexes

Search within the Act

Article 49: Registration

Summary

This article states that before any high-risk AI system is launched or used, the provider or their representative must register themselves and their system in the EU database. This also applies to AI systems that the provider has determined are not high-risk. Public authorities or institutions using high-risk AI systems must also register themselves and the system's use in the EU database. Certain high-risk AI systems used in law enforcement, migration, and border control must be registered in a secure, non-public section of the EU database. Only the Commission and national authorities can access this section.

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.

1. Before placing on the market or putting into service a high-risk AI system listed in Annex III, with the exception of high-risk AI systems referred to in point 2 of Annex III, the provider or, where applicable, the authorised representative shall register themselves and their system in the EU database referred to in Article 71.

2. Before placing on the market or putting into service an AI system for which the provider has concluded that it is not high-risk according to Article 6(3), that provider or, where applicable, the authorised representative shall register themselves and that system in the EU database referred to in Article 71.

3. Before putting into service or using a high-risk AI system listed in Annex III, with the exception of high-risk AI systems listed in point 2 of Annex III, deployers that are public authorities, Union institutions, bodies, offices or agencies or persons acting on their behalf shall register themselves, select the system and register its use in the EU database referred to in Article 71.

4. For high-risk AI systems referred to in points 1, 6 and 7 of Annex III, in the areas of law enforcement, migration, asylum and border control management, the registration referred to in paragraphs 1, 2 and 3 of this Article shall be in a secure non-public section of the EU database referred to in Article 71 and shall include only the following information, as applicable, referred to in:

(a) section A, points 1 to 10, of Annex VIII, with the exception of points 6, 8 and 9;

(b) Section B, points 1 to 5, and points 8 and 9 of Annex VIII;

(c) section C, points 1 to 3, of Annex VIII;

(d) points 1, 2, 3 and 5, of Annex IX. Only the Commission and national authorities referred to in Article 74(8) shall have access to the respective restricted sections of the EU database listed in the first subparagraph of this paragraph.

5. High-risk AI systems referred to in point 2 of Annex III shall be registered at national level.

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The text used in this tool is the ‘Artificial Intelligence Act, Corrigendum, 19 April 2024’. Interinstitutional File: 2021/0106(COD)