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Table of Contents
Title I: General Provisions
Art. 1 Subject MatterArt. 2 ScopeArt. 3 DefinitionsArt. 4 Implementing Acts
Title IA: General Purpose AI Systems
Art. 4a Compliance of General Purpose AI Systems with this RegulationArt. 4b AI LiteracyArt. 4c Exceptions to Article 4b
Title II: Prohibited Artificial Intelligence Practices
Art. 5 Prohibited Artificial Intelligence Practices
Title III: Classification of AI Systems as High-Risk
Chapter 1: Classification of AI Systems as High-Risk
Art. 6 Classification Rules for High-Risk AI Systems
Art. 7 Amendments to Annex IIIChapter 2: Requirements for High-Risk AI Systems
Art. 8 Compliance with the Requirements
Art. 9 Risk Management System
Art. 10 Data and Data Governance
Art. 11 Technical Documentation
Art. 12 Record-Keeping
Art. 13 Transparency and Provision of Information to Deployers
Art. 14 Human Oversight
Art. 15 Accuracy, Robustness and Cybersecurity
Chapter 3: Obligations of Providers and Users of High-Risk AI Systems and Other Parties
Art. 16 Obligations of Providers of High-Risk AI Systems
Art. 17 Quality Management System
Art. 18 Documentation Keeping
Art. 19 Conformity Assessment
Art. 20 Automatically Generated Logs
Art. 21 Corrective Actions and Duty of Information
Art. 22 Duty of Information
Art. 23 Cooperation with Competent Authorities
Art. 23a Conditions for Other Persons to be Subject to the Obligations of a Provider
Art. 24 [Deleted]
Art. 25 Authorised Representatives
Art. 26 Obligations of Importers
Art. 27 Obligations of Distributors
Art. 28 Responsibilities along the AI Value Chain
Art. 29 Obligations of Deployers of High-Risk AI Systems
Art. 29a Fundamental Rights Impact Assessment for High-Risk AI Systems
Chapter 4: Notifying Authorities and Notified Bodies
Art. 30 Notifying Authorities
Art. 31 Application of a Conformity Assessment Body for Notification
Art. 32 Notification Procedure
Art. 33 Requirements Relating to Notified BodiesArt. 33a Presumption of Conformity with Requirements Relating to Notified BodiesArt. 34 Subsidiaries of and Subcontracting by Notified Bodies
Art. 34a Operational Obligations of Notified Bodies
Art. 35 Identification Numbers and Lists of Notified Bodies Designated under this Regulation
Art. 36 Changes to Notifications
Art. 37 Challenge to the Competence of Notified Bodies
Art. 38 Coordination of Notified Bodies
Art. 39 Conformity Assessment Bodies of Third Countries
Chapter 5: Standards, Conformity Assessment, Certification, Registration
Art. 40 Harmonised Standards and Standardisation Deliverables
Art. 41 Common Specifications
Art. 42 Presumption of Conformity with Certain Requirements
Art. 43 Conformity Assessment
Art. 44 Certificates
Art. 45 Appeal Against Decisions of Notified Bodies
Art. 46 Information Obligations of Notified Bodies
Art. 47 Derogation from Conformity Assessment Procedure
Art. 48 EU Declaration of Conformity
Art. 49 CE Marking of Conformity
Art. 50 [Deleted]Art. 51 Registration
Title IV: Transparency Obligations for Providers and Deployers of Certain AI Systems
Art. 52 Transparency Obligations for Providers and Users of Certain AI Systems and GPAI Models
Title VIIIa: General Purpose AI Models
Chapter 1: Classification Rules
Art. 52a Classification of General Purpose AI Models as General Purpose AI Models with Systemic RiskArt. 52b ProcedureChapter 2: Obligations for Providers of General Purpose AI Models
Art. 52c Obligations for Providers of General Purpose AI ModelsArt. 52ca Authorised RepresentativeChapter 3: Obligations for Providers of General Purpose AI Models with Systemic Risk
Art. 52d Obligations for Providers of General Purpose AI Models with Systemic RiskArt. 52e Codes of Practice
Title V: Measures in Support of Innovation
Art. 53 AI Regulatory SandboxesArt. 53a Modalities and Functioning of AI Regulatory SandboxesArt. 54 Further Processing of Personal Data for Developing Certain AI Systems in the Public Interest in the AI Regulatory SandboxArt. 54a Testing of High-Risk AI Systems in Real World Conditions Outside AI Regulatory SandboxesArt. 54b Informed Consent to Participate in Testing in Real World Conditions Outside AI Regulatory SandboxesArt. 55 Measures for Deployers, in Particular SMEs, including Start-UpsArt. 55a Derogations for Specific Operators
Title VI: Governance
Art. 55b Governance at Union LevelChapter 1: European Artificial Intelligence Board
Art. 56 Establishment of the European Artificial Intelligence BoardArt. 57 [Deleted]
Art. 58 Tasks of the BoardArt. 58a Advisory ForumChapter 1A: Scientific Panel of Independent Experts
Art. 58b Scientific Panel of Independent ExpertsArt. 58c Access to the Pool of Experts by the Member StatesChapter 2: National Competent Authorities
Art. 59 Designation of National Competent Authorities and Single Point of Contact
Title VII: EU Database for High-Risk AI Systems Listed in Annex III
Art. 60 EU Database for High-Risk AI Systems Listed in Annex III
Title VIII: Post-Market Monitoring, Information Sharing, Market Surveillance
Chapter 1: Post-Market Monitoring
Art. 61 Post-Market Monitoring by Providers and Post-Market Monitoring Plan for High-Risk AI SystemsChapter 2: Sharing of Information on Serious Incidents
Art. 62 Reporting of Serious IncidentsChapter 3: Enforcement
Art. 63 Market Surveillance and Control of AI Systems in the Union MarketArt. 63a Mutual Assistance, Market Surveillance and Control of General Purpose AI SystemsArt. 63b Supervision of Testing in Real World Conditions by Market Surveillance AuthoritiesArt. 64 Powers of Authorities Protecting Fundamental RightsArt. 65 Procedure for Dealing with AI Systems Presenting a Risk at National LevelArt. 65a Procedure for Dealing with AI Systems Classified by the Provider as a Not High-Risk in Application of Annex IIIArt. 66 Union Safeguard ProcedureArt. 67 Compliant AI Systems Which Present a RiskArt. 68 Formal Non-ComplianceArt. 68a Union Testing Facilities in the Area of Artificial IntelligenceChapter 3b: Remedies
Art. 68b Right to Lodge a Complaint with a Market Surveillance AuthorityArt. 68c A Right to Explanation of Individual Decision-MakingArt. 68d Amendment to Directive (EU) 2020/1828Art. 68e Reporting of Breaches and Protection of Reporting PersonsChapter 3c: Supervision, Investigation, Enforcement and Monitoring in Respect of Providers of General Purpose AI Models
Art. 68f Enforcement of Obligations on Providers of General Purpose AI ModelsArt. 68g Monitoring ActionsArt. 68h Alerts of Systemic Risks by the Scientific PanelArt. 68i Power to Request Documentation and InformationArt. 68j Power to Conduct EvaluationsArt. 68k Power to Request MeasuresArt. 68m Procedural Rights of Economic Operators of the General Purpose AI Model
Title IX: Codes of Conduct
Art. 69 Codes of Conduct for Voluntary Application of Specific Requirements
Title X: Confidentiality and Penalties
Art. 70 Confidentiality
Art. 71 PenaltiesArt. 72 Administrative Fines on Union Institutions, Agencies and BodiesArt. 72a Fines for Providers of General Purpose AI Models
Title XI: Delegation of Power and Committee Procedure
Art. 73 Exercise of the DelegationArt. 74 Committee Procedure
Title XII: Final Provisions
Art. 75 Amendment to Regulation (EC) No 300/2008Art. 76 Amendment to Regulation (EU) No 167/2013Art. 77 Amendment to Regulation (EU) No 168/2013Art. 78 Amendment to Directive 2014/90/EUArt. 79 Amendment to Directive (EU) 2016/797Art. 80 Amendment to Regulation (EU) 2018/858Art. 81 Amendment to Regulation (EU) 2018/1139Art. 82 Amendment to Regulation (EU) 2019/2144Art. 82a Guidelines from the Commission on the Implementation of this RegulationArt. 83 AI Systems Already Placed on the Market or Put into ServiceArt. 84 Evaluation and ReviewArt. 85 Entry into Force and Application
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Article 55a

Derogations for Specific Operators

Updated on Feb 6th 2024 based on the version endorsed by the Coreper I on Feb 2nd

2b. Microenterprises as defined in Article 2(3) of the Annex to the Commission Recommendation 2003/361/EC concerning the definition of micro, small and medium- sized enterprises, provided those enterprises do not have partner enterprises or linked enterprises as defined in Article 3 of the same Annex may fulfil certain elements of the quality management system required by Article 17 of this Regulation in a simplified manner. For this purpose, the Commission shall develop guidelines on the elements of the quality management system which may be fulfilled in a simplified manner considering the needs of micro enterprises without affecting the level of protection and the need for compliance with the requirements for high-risk AI systems.

2c. Paragraph 1 shall not be interpreted as exempting those operators from fulfilling any other requirements and obligations laid down in this Regulation, including those established in Articles 9, 10, 11, 12, 13, 14, 15, 61 and 62.

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[Previous version]

1. The obligations laid down in Article 17 of this Regulation shall not apply to microenterprises as defined in Article 2(3) of the Annex to the Commission Recommendation 2003/361/EC concerning the definition of micro, small and medium-sized enterprises, provided those enterprises do not have partner enterprises or linked enterprises as defined in Article 3 of the same Annex.

2. Paragraph 1 shall not be interpreted as exempting those operators from fulfilling any other requirements and obligations laid down in this Regulation, including those established in Articles 9, 61 and 62.

3. Requirements and obligations for general purpose AI systems laid down in Article 4b shall not apply to micro, small and medium-sized enterprises, provided those enterprises do not have partner enterprises or linked enterprises as defined in Article 3 of the the Annex to the Commission Recommendation 2003/361/EC concerning the definition of micro, small and medium-sized enterprises.

Suitable Recitals
(12c)
(74a)
Article 1
Article 2
Article 3
Article 4
Article 4a
Article 4b
Article 4c
Article 5
Article 6
Article 7
Article 8
Article 9
Article 10
Article 11
Article 12
Article 13
Article 14
Article 15
Article 16
Article 17
Article 18
Article 19
Article 20
Article 21
Article 22
Article 23
Article 23a
Article 24
Article 25
Article 26
Article 27
Article 28
Article 29
Article 29a
Article 30
Article 31
Article 32
Article 33
Article 33a
Article 34
Article 34a
Article 35
Article 36
Article 37
Article 38
Article 39
Article 40
Article 41
Article 42
Article 43
Article 44
Article 45
Article 46
Article 47
Article 48
Article 49
Article 50
Article 51
Article 52
Article 52a
Article 52b
Article 52c
Article 52ca
Article 52d
Article 52e
Article 53
Article 53a
Article 54
Article 54a
Article 54b
Article 55
Article 55a
Article 55b
Article 56
Article 57
Article 58
Article 58a
Article 58b
Article 58c
Article 59
Article 60
Article 61
Article 62
Article 63
Article 63a
Article 63b
Article 64
Article 65
Article 65a
Article 66
Article 67
Article 68
Article 68a
Article 68b
Article 68c
Article 68d
Article 68e
Article 68f
Article 68g
Article 68h
EU AI Act Table of Contents
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