Editors
Contributors
List of Abbreviations
Foreword by Brando Benifei – AI Act: A European Way for Artificial Intelligence
Foreword by Dragos¸ Tudorache
Preface
CHAPTER I. GENERAL PROVISIONS
Article 1
Subject Matter
Patrick Van Eecke & Bartholomäus Regenhardt
Article 2
Scope
Patrick Van Eecke & Bartholomäus Regenhardt
Article 3
Definitions
Lukas Feiler & Beat König
Article 4
AI Literacy
Elora Fernandes, Wayne Holmes & Sopio Zhgenti
CHAPTER II. PROHIBITED AI PRACTICES
Article 5
Prohibited AI Practices
Els J. Kindt & Catherine Jasserand
CHAPTER III. HIGH-RISK AI SYSTEMS
SECTION 1. CLASSIFICATION OF AI SYSTEMS AS HIGH-RISK
Article 6
Classification Rules for High-Risk AI Systems
Guillaume Couneson
Article 7
Amendments to Annex III
Guillaume Couneson
SECTION 2. REQUIREMENTS FOR HIGH-RISK AI SYSTEMS
Article 8
Compliance with the Requirements
David M. Schneeberger, Walter Hötzendorfer & Christof Tschohl
Article 9
Risk Management System
David M. Schneeberger, Walter Hötzendorfer & Christof Tschohl
Article 10
Data and Data Governance
Katerina Yordanova
Article 11
Technical Documentation
Hande Özkayagan Prändl & Katarzyna Barud
Article 12
Record-Keeping
Thomas Marquenie
Article 13
Transparency and Provision of Information to Deployers
Ana Maria Corrêa
Article 14
Human Oversight
Argyri Panezi
Article 15
Accuracy, Robustness and Cybersecurity
Jorge Constantino
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
Stavros Tsipras
Article 17
Quality Management System
Theodoros Karathanasis
Article 18
Documentation Keeping
Wannes Ooms & Victoria Hendrickx
Article 19
Automatically Generated Logs
Fabian Schmieder
Article 20
Corrective Actions and Duty of Information
Daniel Westman & Cecilia Magnusson Sjöberg
Article 21
Cooperation with Competent Authorities
Klaus M. Steinmaurer
Article 22
Authorised Representatives of Providers of High-Risk AI Systems
Graziana Kastl-Riemann
Article 23
Obligations of Importers
Lutz Riede & Oliver Talhoff
Article 24
Obligations of Distributors
Lutz Riede & Oliver Talhoff
Article 25
Responsibilities Along the AI Value Chain
Lutz Riede & Oliver Talhoff
Article 26
Obligations of Deployers of High-Risk AI Systems
Daniel Gallagher
Article 27
Fundamental Rights Impact Assessment for High-Risk AI Systems
Tünde Fülöp & Philipp Poindl
SECTION 4. NOTIFYING AUTHORITIES AND NOTIFIED BODIES
Article 28
Notifying Authorities
Žiga Škorjanc & Kai Korte
Article 29
Application of a Conformity Assessment Body for Notification
Žiga Škorjanc & Kai Korte
Article 30
Notification Procedure
Žiga Škorjanc & Kai Korte
Article 31
Requirements Relating to Notified Bodies
Žiga Škorjanc & Kai Korte
Article 32
Presumption of Conformity with Requirements Relating to Notified Bodies
Žiga Škorjanc & Kai Korte
Article 33
Subsidiaries of and Subcontracting by Notified Bodies
Žiga Škorjanc & Kai Korte
Article 34
Operational Obligations of Notified Bodies
Žiga Škorjanc & Kai Korte
Article 35
Identification Numbers and Lists of Notified Bodies
Iana Kazeeva
Article 36
Changes to Notifications
Iana Kazeeva
Article 37
Challenge to the Competence of Notified Bodies
Iana Kazeeva
Article 38
Coordination of Notified Bodies
Iana Kazeeva
Article 39
Conformity Assessment Bodies of Third Countries
Iana Kazeeva
SECTION 5. STANDARDS, CONFORMITY ASSESSMENT, CERTIFICATES, REGISTRATION
Article 40
Harmonised Standards and Standardization Deliverables
Koen Vranckaert
Article 41
Common Specifications
Koen Vranckaert
Article 42
Presumption of Conformity with Certain Requirements
Koen Vranckaert
Article 43
Conformity Assessment
Hande Özkayagan Prändl & Klaudia Kwiatkowska
Article 44
Certificates
Klaudia Kwiatkowska & Clara Saillant
Article 45
Information Obligations of Notified Bodies
Victoria Hendrickx & Wannes Ooms
Article 46
Derogation from Conformity Assessment Procedure
Wannes Ooms & Victoria Hendrickx
Article 47
EU Declaration of Conformity
Victoria Hendrickx & Wannes Ooms
Article 48
CE Marking
Victoria Hendrickx & Wannes Ooms
Article 49
Registration
Adam Harkens
CHAPTER IV. TRANSPARENCY OBLIGATIONS FOR PROVIDERS AND DEPLOYERS OF CERTAIN AI SYSTEMS
Article 50
Transparency Obligations for Providers and Deployers of Certain AI Systems
Thomas Gils
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
Toby Bond & Shima Abbady
Article 52
Procedure
Toby Bond & Shima Abbady
SECTION 2. OBLIGATIONS FOR PROVIDERS OF GENERAL-PURPOSE AI MODELS
Article 53
Obligations for Providers of General-Purpose AI Models
Nynke Elske Vellinga & Jeanne Mifsud Bonnici
Article 54
Authorised Representative
Nynke Elske Vellinga & Jeanne Mifsud Bonnici
SECTION 3. OBLIGATIONS OF PROVIDERS OF GENERAL-PURPOSE AI MODELS WITH SYSTEMIC RISK
Article 55
Obligations of Providers of General-Purpose AI Models with Systemic Risk
Nynke Elske Vellinga & Jeanne Mifsud Bonnici
SECTION 4. CODES OF PRACTICE
Article 56
Codes of Practice
Nynke Elske Vellinga & Jeanne Mifsud Bonnici
CHAPTER VI. MEASURES IN SUPPORT OF INNOVATION
Article 57
AI Regulatory Sandboxes
Norberto de Andrade
Article 58
Detailed Arrangements for, and Functioning of, AI Regulatory Sandboxes
Norberto de Andrade
Article 59
Further Processing of Personal Data for Developing Certain AI Systems in the Public Interest in the AI Regulatory Sandbox
Thomas Binder & Iris Eisenberger
Article 60
Testing of High-Risk AI Systems in Real-World Conditions Outside AI Regulatory Sandboxes
Thomas Binder & Iris Eisenberger
Article 61
Informed Consent to Participate in Testing in Real World Conditions Outside AI Regulatory Sandboxes
Samson Y. Esayas & Luca Tosoni
Article 62
Measures for Providers and Deployers, in Particular SMEs, Including Start-Ups
Thomas Binder & Iris Eisenberger
Article 63
Derogations for Specific Operators
Antonella Zarra
CHAPTER VII. GOVERNANCE
SECTION 1. GOVERNANCE AT UNION LEVEL
Article 64
AI Office
Matthias Schmidl & Andreas Rohner
Article 65
Establishment and Structure of the European Artificial Intelligence Board
Matthias Schmidl & Andreas Rohner
Article 66
Tasks of the Board
Matthias Schmidl & Andreas Rohner
Article 67
Advisory Forum
Matthias Schmidl & Andreas Rohner
Article 68
Scientific Panel of Independent Experts
Matthias Schmidl & Andreas Rohner
Article 69
Access to the Pool of Experts by the Member States
Matthias Schmidl & Andreas Rohner
SECTION 2. NATIONAL COMPETENT AUTHORITIES
Article 70
Designation of National Competent Authorities and Single Point of Contact
Matthias Schmidl & Andreas Rohner
CHAPTER VIII. EU DATABASE FOR HIGH-RISK AI SYSTEMS
Article 71
EU Database for High-Risk AI Systems Listed in Annex III
Adam Harkens
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
Ayça Atabey, Lachlan Urquhart & Burkhard Schafer
SECTION 2. SHARING OF INFORMATION ON SERIOUS INCIDENTS
Article 73
Reporting of Serious Incidents
Ayça Atabey, Lachlan Urquhart & Burkhard Schafer
SECTION 3. ENFORCEMENT
Article 74
Market Surveillance and Control of AI Systems in the Union Market
Laura Drechsler & Plixavra Vogiatzoglou
Article 75
Mutual Assistance, Market Surveillance and Control of General-Purpose AI Systems
Nikolas Smirra
Article 76
Supervision of Testing in Real World Conditions by Market Surveillance Authorities
Nikolas Smirra
Article 77
Powers of Authorities Protecting Fundamental Rights
Plixavra Vogiatzoglou & Laura Drechsler
Article 78
Confidentiality
Irmak Erdogan
Article 79
Procedure at National Level for Dealing with AI Systems Presenting a Risk
Tobias Mahler, Peter Alexander Earls Davis & Sebastian Felix Schwemer
Article 80
Procedure for Dealing with AI Systems Classified by the Provider as Non-High-Risk in Application of Annex III
Tobias Mahler & Sebastian Felix Schwemer
Article 81
Union Safeguard Procedure
Luca Tosoni & Samson Y. Esayas
Article 82
Compliant AI Systems which Present a Risk
Bernadette Zelger
Article 83
Formal Non-compliance
Bernadette Zelger
Article 84
Union AI Testing Support Structure
Bernadette Zelger
SECTION 4. REMEDIES
Article 85
Right to Lodge a Complaint with a Market Surveillance Authority
Waltraut Kotschy
Article 86
Right to Explanation of Individual Decision-Making
Maja Brkan & Hana Palcic Vilfan
Article 87
Reporting of Infringements and Protection of Reporting Persons
Amélie Lachapelle
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
Quentin B. Schäfer
Article 89
Monitoring Actions
Quentin B. Schäfer
Article 90
Alerts of Systemic Risks by the Scientific Panel
Lutz Riede & Oliver Talhoff
Article 91
Power to Request Documentation and Information
Lutz Riede & Oliver Talhoff
Article 92
Power to Conduct Evaluations
Lutz Riede & Oliver Talhoff
Article 93
Power to Request Measures
Carlota Cuatrecasas Monforte
Article 94
Procedural Rights of Economic Operators of the General Purpose AI Model
Arun Kapoor
CHAPTER X. CODES OF CONDUCT AND GUIDELINES
Article 95
Codes of Conduct for Voluntary Application of Specific Requirements
Arnd Haller, Caroline Coesemans & Lukas Maly
Article 96
Guidelines from the Commission on the Implementation of this Regulation
Clara Saillant & Katarzyna Barud
CHAPTER XI. DELEGATION OF POWER AND COMMITTEE PROCEDURE
Article 97
Exercise of the Delegation
Clara Saillant
Article 98
Committee Procedure
Clara Saillant
CHAPTER XII. PENALTIES
Article 99
Penalties
Anna Buchta
Article 100
Administrative Fines on Union Institutions, Bodies, Offices and Agencies
Anna Buchta
Article 101
Fines for Providers of General-Purpose AI Models
Anna Buchta
CHAPTER XIII. FINAL PROVISIONS
Article 102
Amendment to Regulation (EC) No. 300/2008
Ceyhun Necati Pehlivan
Article 103
Amendment to Regulation (EU) No. 167/2013
Ceyhun Necati Pehlivan
Article 104
Amendment to Regulation (EU) No. 168/2013
Ceyhun Necati Pehlivan
Article 105
Amendment to Directive 2014/90/EU
Ceyhun Necati Pehlivan
Article 106
Amendment to Directive (EU) 2016/797
Ceyhun Necati Pehlivan
Article 107
Amendment to Regulation (EU) 2018/858
Ceyhun Necati Pehlivan
Article 108
Amendment to Regulation (EU) 2018/1139
Ceyhun Necati Pehlivan
Article 109
Amendment to Regulation (EU) 2019/2144
Ceyhun Necati Pehlivan
Article 110
Amendment to Directive (EU) 2020/1828
Kenny Henderson, Reeve Boyd & Tobias Seger
Article 111
AI Systems Already Placed on the Market or Put into Service and General-Purpose AI Models Already Placed on the Marked [sic]
Adriana Winkelmeier & Christoph Korab
Article 112
Evaluation and Review
Adriana Winkelmeier & Christoph Korab
Article 113
Entry into Force and Application
Ceyhun Necati Pehlivan
