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 99: Penalties

Summary

This article states that member countries must establish rules for penalties and enforcement measures for violations of the Act. These penalties must be effective, proportionate, and dissuasive, and consider the interests of small and medium-sized enterprises (SMEs) and startups. Non-compliance with certain AI practices can result in fines up to 35 million EUR or 7% of a company's annual turnover. Other violations can result in fines up to 15 million EUR or 3% of a company's annual turnover. Providing incorrect or misleading information can result in fines up to 7.5 million EUR or 1% of a company's annual turnover. SMEs will receive lower fines. The severity of the fine will depend on various factors, including the nature of the violation, the size of the company, and any previous violations. Member states must report annually to the Commission on the fines they have issued.

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. In accordance with the terms and conditions laid down in this Regulation, Member States shall lay down the rules on penalties and other enforcement measures, which may also include warnings and non-monetary measures, applicable to infringements of this Regulation by operators, and shall take all measures necessary to ensure that they are properly and effectively implemented, thereby taking into account the guidelines issued by the Commission pursuant to Article 96. The penalties provided for shall be effective, proportionate and dissuasive. They shall take into account the interests of SMEs, including start-ups, and their economic viability.

2. The Member States shall, without delay and at the latest by the date of entry into application, notify the Commission of the rules on penalties and of other enforcement measures referred to in paragraph 1, and shall notify it, without delay, of any subsequent amendment to them.

3. Non-compliance with the prohibition of the AI practices referred to in Article 5 shall be subject to administrative fines of up to 35 000 000 EUR or, if the offender is an undertaking, up to 7 % of its total worldwide annual turnover for the preceding financial year, whichever is higher.

4. Non-compliance with any of the following provisions related to operators or notified bodies, other than those laid down in Articles 5, shall be subject to administrative fines of up to 15 000 000 EUR or, if the offender is an undertaking, up to 3 % of its total worldwide annual turnover for the preceding financial year, whichever is higher:

(a) obligations of providers pursuant to Article 16;

(b) obligations of authorised representatives pursuant to Article 22;

(c) obligations of importers pursuant to Article 23;

(d) obligations of distributors pursuant to Article 24;

(e) obligations of deployers pursuant to Article 26;

(f) requirements and obligations of notified bodies pursuant to Article 31, Article 33(1), (3) and (4) or Article 34;

(g) transparency obligations for providers and deployers pursuant to Article 50.

5. The supply of incorrect, incomplete or misleading information to notified bodies or national competent authorities in reply to a request shall be subject to administrative fines of up to 7 500 000 EUR or, if the offender is an undertaking, up to 1 % of its total worldwide annual turnover for the preceding financial year, whichever is higher.

6. In the case of SMEs, including start-ups, each fine referred to in this Article shall be up to the percentages or amount referred to in paragraphs 3, 4 and 5, whichever thereof is lower.

7. When deciding whether to impose an administrative fine and when deciding on the amount of the administrative fine in each individual case, all relevant circumstances of the specific situation shall be taken into account and, as appropriate, regard shall be given to the following:

(a) the nature, gravity and duration of the infringement and of its consequences, taking into account the purpose of the AI system, as well as, where appropriate, the number of affected persons and the level of damage suffered by them;

(b) whether administrative fines have already been applied by other market surveillance authorities to the same operator for the same infringement;

(c) whether administrative fines have already been applied by other authorities to the same operator for infringements of other Union or national law, when such infringements result from the same activity or omission constituting a relevant infringement of this Regulation;

(d) the size, the annual turnover and market share of the operator committing the infringement;

(e) any other aggravating or mitigating factor applicable to the circumstances of the case, such as financial benefits gained, or losses avoided, directly or indirectly, from the infringement;

(f) the degree of cooperation with the national competent authorities, in order to remedy the infringement and mitigate the possible adverse effects of the infringement;

(g) the degree of responsibility of the operator taking into account the technical and organisational measures implemented by it;

(h) the manner in which the infringement became known to the national competent authorities, in particular whether, and if so to what extent, the operator notified the infringement;

(i) the intentional or negligent character of the infringement;

(j) any action taken by the operator to mitigate the harm suffered by the affected persons.

8. Each Member State shall lay down rules on to what extent administrative fines may be imposed on public authorities and bodies established in that Member State.

9. Depending on the legal system of the Member States, the rules on administrative fines may be applied in such a manner that the fines are imposed by competent national courts or by other bodies, as applicable in those Member States. The application of such rules in those Member States shall have an equivalent effect.

10. The exercise of powers under this Article shall be subject to appropriate procedural safeguards in accordance with Union and national law, including effective judicial remedies and due process.

11. Member States shall, on an annual basis, report to the Commission about the administrative fines they have issued during that year, in accordance with this Article, and about any related litigation or judicial proceedings.

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