Table of contents

Chapter 1: Classification of AI Systems as High-Risk

Article 6: Classification Rules for High-Risk AI Systems

Article 7: Amendments to Annex III

Chapter 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

Chapter 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 20: Automatically Generated Logs

Article 21: Corrective Actions and Duty of Information

Article 23: Cooperation with Competent Authorities

Article 25: Authorised Representatives

Article 26: Obligations of Importers

Article 27: Obligations of Distributors

Article 28: Responsibilities Along the AI Value Chain

Article 29: Obligations of Deployers of High-Risk AI Systems

Chapter 4: Notifying Authorities and Notified Bodies

Article 30: Notifying Authorities

Article 31: Application of a Conformity Assessment Body for Notification

Article 32: Notification Procedure

Article 33: Requirements Relating to Notified Bodies

Article 33a: Presumption of Conformity with Requirements Relating to Notified Bodies

Article 34: Subsidiaries of and Subcontracting by Notified Bodies

Article 34a: 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

Chapter 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 46: Information Obligations of Notified Bodies

Article 47: Derogation from Conformity Assessment Procedure

Article 48: EU Declaration of Conformity

Article 49: CE Marking of Conformity

Article 51: Registration

Chapter 1: Post-Market Monitoring

Article 61: Post-Market Monitoring by Providers and Post-Market Monitoring Plan for High-Risk AI Systems

Chapter 2: Sharing of Information on Serious Incidents

Article 62: Reporting of Serious Incidents

Chapter 3: Enforcement

Article 63: Market Surveillance and Control of AI Systems in the Union Market

Article 63a: Mutual Assistance, Market Surveillance and Control of General Purpose AI Systems

Article 63b: Supervision of Testing in Real World Conditions by Market Surveillance Authorities

Article 64: Powers of Authorities Protecting Fundamental Rights

Article 65: Procedure for Dealing with AI Systems Presenting a Risk at National Level

Article 65a: Procedure for Dealing with AI Systems Classified by the Provider as a Not High-Risk in Application of Annex III

Article 66: Union Safeguard Procedure

Article 67: Compliant AI Systems Which Present a Risk

Article 68: Formal Non-Compliance

Article 68a: EU AI Testing Support Structures in the Area of Artificial Intelligence

Chapter 3b: Remedies

Article 68a(1): Right to Lodge a Complaint with a Market Surveillance Authority

Article 68c: A Right to Explanation of Individual Decision-Making

Article 68d: Amendment to Directive (EU) 2020/1828

Article 68e: Reporting of Breaches and Protection of Reporting Persons

Chapter 3c: Supervision, Investigation, Enforcement and Monitoring in Respect of Providers of General Purpose AI Models

Article 68f: Enforcement of Obligations on Providers of General Purpose AI Models

Article 68g : Monitoring Actions

Article 68h: Alerts of Systemic Risks by the Scientific Panel

Article 68i: Power to Request Documentation and Information

Article 68j: Power to Conduct Evaluations

Article 68k: Power to Request Measures

Article 68m: Procedural Rights of Economic Operators of the General Purpose AI Model

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

High-risk AI systems pursuant to Article 6(2) are the AI systems listed in any of the following areas:

1. Biometrics, insofar as their use is permitted under relevant Union or national law:

(a) Remote biometric identification systems. This shall not include AI systems intended to be used for biometric verification whose sole purpose is to confirm that a specific natural person is the person he or she claims to be;

(aa) AI systems intended to be used for biometric categorisation, according to sensitive or protected attributes or characteristics based on the inference of those attributes or characteristics;

(ab) AI systems intended to be used for emotion recognition.

2. Critical infrastructure:

(a) AI systems intended to be used as safety components in the management and operation of critical digital infrastructure, road traffic and the supply of water, gas, heating and electricity.

3. Education and vocational training:

(a) AI systems intended to be used to determine access or admission or to assign natural persons to educational and vocational training institutions at all levels;

(b) AI systems intended to be used to evaluate learning outcomes, including when those outcomes are used to steer the learning process of natural persons in educational and vocational training institutions at all levels;

(ba) AI systems intended to be used for the purpose of assessing the appropriate level of education that individual will receive or will be able to access, in the context of/within education and vocational training institution;

(bb) AI systems intended to be used for monitoring and detecting prohibited behaviour of students during tests in the context of/within education and vocational training institutions.

4. Employment, workers management and access to self-employment:

(a) AI systems intended to be used for recruitment or selection of natural persons, notably to place targeted job advertisements, to analyse and filter job applications, and to evaluate candidates;

(b) AI intended to be used to make decisions affecting terms of the work related relationships, promotion and termination of work-related contractual relationships, to allocate tasks based on individual behaviour or personal traits or characteristics and to monitor and evaluate performance and behaviour of persons in such relationships.

5. Access to and enjoyment of essential private services and essential public services and benefits:

(a) AI systems intended to be used by public authorities or on behalf of public authorities to evaluate the eligibility of natural persons for essential public assistance benefits and services, including healthcare services, as well as to grant, reduce, revoke, or reclaim such benefits and services;

(b) AI systems intended to be used to evaluate the creditworthiness of natural persons or establish their credit score , with the exception of AI systems used for the purpose of detecting financial fraud;

(c) AI systems intended to evaluate and classify emergency calls by natural persons or to be used to dispatch, or to establish priority in the dispatching of emergency first response services, including by police, firefighters and medical aid, as well as of emergency healthcare patient triage systems;

(ca) AI systems intended to be used for risk assessment and pricing in relation to natural persons in the case of life and health insurance.

6. Law enforcement, insofar as their use is permitted under relevant Union or national law:

(a) AI systems intended to be used by or on behalf of law enforcement authorities, or by Union institutions, agencies, offices or bodies in support of law enforcement authorities or on their behalf to assess the risk of a natural person to become a victim of criminal offences;

(b) AI systems intended to be used by or on behalf of law enforcement authorities or by Union institutions, bodies and agencies in support of Law enforcement authorities as polygraphs and similar tools;

(c) [deleted;

(d) AI systems intended to be used by or on behalf of law enforcement authorities, or by Union institutions, agencies, offices or bodies in support of law enforcement authorities to evaluate the reliability of evidence in the course of investigation or prosecution of criminal offences;

(e) AI systems intended to be used by law enforcement authorities or on their behalf or by Union institutions, agencies, offices or bodies in support of law enforcement authorities for assessing the risk of a natural person of offending or re-offending not solely based on profiling of natural persons as referred to in Article 3(4) of Directive (EU) 2016/680 or to assess personality traits and characteristics or past criminal behaviour of natural persons or groups;

(f) AI systems intended to be used by or on behalf of law enforcement authorities or by Union agencies institutions, agencies, offices or bodies in support of law enforcement authorities for profiling of natural persons as referred to in Article 3(4) of Directive (EU) 2016/680 in the course of detection, investigation or prosecution of criminal offences;

(g) [deleted].

7. Migration, asylum and border control management, insofar as their use is permitted under relevant Union or national law:

(a) AI systems intended to be used by competent public authorities as polygraphs and similar tools;

(b) AI systems intended to be used by or on behalf of competent public authorities or by Union agencies, offices or bodies to assess a risk, including a security risk, a risk of irregular migration, or a health risk, posed by a natural person who intends to enter or has entered into the territory of a Member State;

(c) [deleted];

(d) AI systems intended to be used by or on behalf of competent public authorities or by Union agencies, offices or bodies to assist competent public authorities for the examination of applications for asylum, visa and residence permits and associated complaints with regard to the eligibility of the natural persons applying for a status, including related assessment of the reliability of evidence;

(da) AI systems intended to be used by or on behalf of competent public authorities, including Union agencies, offices or bodies, in the context of migration, asylum and border control management, for the purpose of detecting, recognising or identifying natural persons with the exception of verification of travel documents.

8. Administration of justice and democratic processes:

(a) AI systems intended to be used by a judicial authority or on their behalf to assist a judicial authority in researching and interpreting facts and the law and in applying the law to a concrete set of facts or used in a similar way in alternative dispute resolution;

(aa) AI systems intended to be used for influencing the outcome of an election or referendum or the voting behaviour of natural persons in the exercise of their vote in elections or referenda. This does not include AI systems whose output natural persons are not directly exposed to, such as tools used to organise, optimise and structure political campaigns from an administrative and logistic point of view;

(#) [deleted].