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

Article 5: Prohibited Artificial Intelligence Practices

1. The following artificial intelligence practices shall be prohibited:

(a) the placing on the market, putting into service or use of an AI system that deploys subliminal techniques beyond a person’s consciousness or purposefully manipulative or deceptive techniques, with the objective to or the effect of materially distorting a person’s or a group of persons’ behaviour by appreciably impairing the person’s ability to make an informed decision, thereby causing the person to take a decision that that person would not have otherwise taken in a manner that causes or is likely to cause that person, another person or group of persons significant harm;

(b) the placing on the market, putting into service or use of an AI system that exploits any of the vulnerabilities of a person or a specific group of persons due to their age, disability or a specific social or economic situation, with the objective to or the effect of materially distorting the behaviour of that person or a person pertaining to that group in a manner that causes or is reasonably likely to cause that person or another person significant harm;

(ba) the placing on the market or putting into service for this specific purpose, or use of biometric categorisation systems that categorise individually natural persons based on their biometric data to deduce or infer their race, political opinions, trade union membership, religious or philosophical beliefs, sex life or sexual orientation. This prohibition does not cover any labelling or filtering of lawfully acquired biometric datasets, such as images, based on biometric data or categorizing of biometric data in the area of law enforcement;

(c) the placing on the market, putting into service or use of AI systems for the evaluation or classification of natural persons or groups thereof over a certain period of time based on their social behaviour or known, inferred or predicted personal or personality characteristics, with the social score leading to either or both of the following:

(i) detrimental or unfavourable treatment of certain natural persons or whole groups thereof in social contexts that are unrelated to the contexts in which the data was originally generated or collected;

(ii) detrimental or unfavourable treatment of certain natural persons or groups thereof that is unjustified or disproportionate to their social behaviour or its gravity;

(d) the use of ‘real-time’ remote biometric identification systems in publicly accessible spaces for the purpose of law enforcement unless and in as far as such use is strictly necessary for one of the following objectives:

(i) the targeted search for specific victims of abduction, trafficking in human beings and sexual exploitation of human beings as well as search for missing persons;

(ii) the prevention of a specific, substantial and imminent threat to the life or physical safety of natural persons or a genuine and present or genuine and foreseeable threat of a terrorist attack;

(iii) the localisation or identification of a person suspected of having committed a criminal offence, for the purposes of conducting a criminal investigation, prosecution or executing a criminal penalty for offences, referred to in Annex IIa and punishable in the Member State concerned by a custodial sentence or a detention order for a maximum period of at least four years. This paragraph is without prejudice to the provisions in Article 9 of the GDPR for the processing of biometric data for purposes other than law enforcement;

(da) the placing on the market, putting into service for this specific purpose, or use of an AI system for making risk assessments of natural persons in order to assess or predict the risk of a natural person to commit a criminal offence, based solely on the profiling of a natural person or on assessing their personality traits and characteristics; This prohibition shall not apply to AI systems used to support the human assessment of the involvement of a person in a criminal activity, which is already based on objective and verifiable facts directly linked to a criminal activity;

(db) the placing on the market, putting into service for this specific purpose, or use of AI systems that create or expand facial recognition databases through the untargeted scraping of facial images from the internet or CCTV footage; dc) the placing on the market, putting into service for this specific purpose, or use of AI systems to infer emotions of a natural person in the areas of workplace and education institutions except in cases where the use of the AI system is intended to be put in place or into the market for medical or safety reasons;

(iiid) deleted.

1a. This Article shall not affect the prohibitions that apply where an artificial intelligence practice infringes other Union law.

2. The use of ‘real-time’ remote biometric identification systems in publicly accessible spaces for the purpose of law enforcement for any of the objectives referred to in paragraph 1 point d) shall only be deployed for the purposes under paragraph 1, point d) to confirm the specifically targeted individual’s identity and it shall take into account the following elements:

(a) the nature of the situation giving rise to the possible use, in particular the seriousness, probability and scale of the harm caused in the absence of the use of the system;

(b) the consequences of the use of the system for the rights and freedoms of all persons concerned, in particular the seriousness, probability and scale of those consequences. In addition, the use of ‘real-time’ remote biometric identification systems in publicly accessible spaces for the purpose of law enforcement for any of the objectives referred to in paragraph 1 point d) shall comply with necessary and proportionate safeguards and conditions in relation to the use in accordance with national legislations authorizing the use thereof, in particular as regards the temporal, geographic and personal limitations. The use of the ‘real-time’ remote biometric identification system in publicly accessible spaces shall only be authorised if the law enforcement authority has completed a fundamental rights impact assessment as provided for in Article 29a and has registered the system in the database according to Article 51. However, in duly justified cases of urgency, the use of the system may be commenced without the registration, provided that the registration is completed without undue delay.

3. As regards paragraphs 1, point (d) and 2, each use for the purpose of law enforcement of a ‘real-time’ remote biometric identification system in publicly accessible spaces shall be subject to a prior authorisation granted by a judicial authority or an independent administrative authority whose decision is binding of the Member State in which the use is to take place, issued upon a reasoned request and in accordance with the detailed rules of national law referred to in paragraph 4. However, in a duly justified situation of urgency, the use of the system may be commenced without an authorisation provided that, such authorisation shall be requested without undue delay, at the latest within 24 hours. If such authorisation is rejected, its use shall be stopped with immediate effect and all the data, as well as the results and outputs of this use shall be immediately discarded and deleted. The competent judicial authority or an independent administrative authority whose decision is binding shall only grant the authorisation where it is satisfied, based on objective evidence or clear indications presented to it, that the use of the ‘real-time’ remote biometric identification system at issue is necessary for and proportionate to achieving one of the objectives specified in paragraph 1, point (d), as identified in the request and, in particular, remains limited to what is strictly necessary concerning the period of time as well as geographic and personal scope. In deciding on the request, the competent judicial authority or an independent administrative authority whose decision is binding shall take into account the elements referred to in paragraph 2. It shall be ensured that no decision that produces an adverse legal effect on a person may be taken by the judicial authority or an independent administrative authority whose decision is binding solely based on the output of the remote biometric identification system.

3a. Without prejudice to paragraph 3, each use of a ‘real-time’ remote biometric identification system in publicly accessible spaces for law enforcement purposes shall be notified to the relevant market surveillance authority and the national data protection authority in accordance with the national rules referred to in paragraph 4. The notification shall as a minimum contain the information specified under paragraph 5 and shall not include sensitive operational data.

4. A Member State may decide to provide for the possibility to fully or partially authorise the use of ‘real-time’ remote biometric identification systems in publicly accessible spaces for the purpose of law enforcement within the limits and under the conditions listed in paragraphs 1, point (d), 2 and 3. Member States concerned shall lay down in their national law the necessary detailed rules for the request, issuance and exercise of, as well as supervision and reporting relating to, the authorisations referred to in paragraph 3. Those rules shall also specify in respect of which of the objectives listed in paragraph 1, point (d), including which of the criminal offences referred to in point (iii) thereof, the competent authorities may be authorised to use those systems for the purpose of law enforcement. Member States shall notify those rules to the Commission at the latest 30 days following the adoption thereof. Member States may introduce, in accordance with Union law, more restrictive laws on the use of remote biometric identification systems.

5. National market surveillance authorities and the national data protection authorities of Member States that have been notified of the use of ‘real-time’ remote biometric identification systems in publicly accessible spaces for law enforcement purposes pursuant to paragraph 3a shall submit to the Commission annual reports on such use. For that purpose, the Commission shall provide Member States and national market surveillance and data protection authorities with a template, including information on the number of the decisions taken by competent judicial authorities or an independent administrative authority whose decision is binding upon requests for authorisations in accordance with paragraph 3 and their result.

6. The Commission shall publish annual reports on the use of ‘real-time’ remote biometric identification systems in publicly accessible spaces for law enforcement purposes based on aggregated data in Member States based on the annual reports referred to in paragraph 5, which shall not include sensitive operational data of the related law enforcement activities.