Artificial Intelligence Act
El AI Act clasifica los sistemas de IA por nivel de riesgo (inaceptable, alto, limitado, mínimo) e impone obligaciones proporcionales a fabricantes, importadores y distribuidores. Los sistemas de IA de alto riesgo en sectores críticos requieren evaluación de conformidad antes de su puesta en mercado.
En vigor
2 ago 2026
Articulos
113
Guias oficiales
6
Guias tecnicas y fuentes oficiales
European Commission - AI Act
Pagina oficial sobre el AI Act, calendario, obligaciones y enfoque por riesgo.
AI Office - Guidelines on AI system definition
Guia oficial para determinar si un software es un sistema de IA bajo el AI Act.
AI Office - Guidelines on prohibited AI practices
Guia oficial sobre practicas prohibidas por el AI Act.
AI Office - General-Purpose AI Code of Practice
Codigo de practica para proveedores de modelos GPAI.
European Commission - Standardisation of the AI Act
Estandares armonizados para cumplir requisitos de sistemas de IA de alto riesgo.
European Commission - AI Act
Pagina oficial de la Comision Europea sobre el AI Act, calendario y obligaciones.
General
113Subject matter`
El artículo 1 (Subject matter`) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Scope
El artículo 2 (Scope) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Definitions
El artículo 3 (Definitions) establece obligaciones y criterios operativos dentro del marco DORA. For the purposes of this Regulation, the following definitions apply: (1) ‘AI system’ means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implici
AI literacy
El artículo 4 (AI literacy) establece obligaciones y criterios operativos dentro del marco DORA. Providers and deployers of AI systems shall take measures to ensure, to their best extent, a sufficient level of AI literacy of their staff and other persons dealing with the operation and use of AI systems on their behalf, taking into account their technical
Prohibited AI practices
El artículo 5 (Prohibited AI practices) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Classification rules for high-risk AI systems
El artículo 6 (Classification rules for high-risk AI systems) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Amendments to Annex III
El artículo 7 (Amendments to Annex III) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Compliance with the requirements
El artículo 8 (Compliance with the requirements) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Risk management system
El artículo 9 (Risk management system) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Data and data governance
El artículo 10 (Data and data governance) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Technical documentation
El artículo 11 (Technical documentation) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Record-keeping
El artículo 12 (Record-keeping) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Transparency and provision of information to deployers
El artículo 13 (Transparency and provision of information to deployers) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Human oversight
El artículo 14 (Human oversight) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Accuracy, robustness and cybersecurity
El artículo 15 (Accuracy, robustness and cybersecurity) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Obligations of providers of high-risk AI systems
El artículo 16 (Obligations of providers of high-risk AI systems) establece obligaciones y criterios operativos dentro del marco DORA. Providers of high-risk AI systems shall: (a) ensure that their high-risk AI systems are compliant with the requirements set out in Section 2; (b) indicate on the high-risk AI system or, where that is not possible, on its packaging or its accompanying documenta
Quality management system
El artículo 17 (Quality management system) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Documentation keeping
El artículo 18 (Documentation keeping) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Automatically generated logs
El artículo 19 (Automatically generated logs) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Corrective actions and duty of information
El artículo 20 (Corrective actions and duty of information) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Cooperation with competent authorities
El artículo 21 (Cooperation with competent authorities) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Authorised representatives of providers of high-risk AI systems
El artículo 22 (Authorised representatives of providers of high-risk AI systems) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Obligations of importers
El artículo 23 (Obligations of importers) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Obligations of distributors
El artículo 24 (Obligations of distributors) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Responsibilities along the AI value chain
El artículo 25 (Responsibilities along the AI value chain) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Obligations of deployers of high-risk AI systems
El artículo 26 (Obligations of deployers of high-risk AI systems) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Fundamental rights impact assessment for high-risk AI systems
El artículo 27 (Fundamental rights impact assessment for high-risk AI systems) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Notifying authorities
El artículo 28 (Notifying authorities) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Application of a conformity assessment body for notification
El artículo 29 (Application of a conformity assessment body for notification) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Notification procedure
El artículo 30 (Notification procedure) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Requirements relating to notified bodies
El artículo 31 (Requirements relating to notified bodies) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Presumption of conformity with requirements relating to notified bodies
El artículo 32 (Presumption of conformity with requirements relating to notified bodies) establece obligaciones y criterios operativos dentro del marco DORA. Where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union , it shall be presumed t
Subsidiaries of notified bodies and subcontracting
El artículo 33 (Subsidiaries of notified bodies and subcontracting) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Operational obligations of notified bodies
El artículo 34 (Operational obligations of notified bodies) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Identification numbers and lists of notified bodies
El artículo 35 (Identification numbers and lists of notified bodies) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Changes to notifications
El artículo 36 (Changes to notifications) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Challenge to the competence of notified bodies
El artículo 37 (Challenge to the competence of notified bodies) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Coordination of notified bodies
El artículo 38 (Coordination of notified bodies) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Conformity assessment bodies of third countries
El artículo 39 (Conformity assessment bodies of third countries) establece obligaciones y criterios operativos dentro del marco DORA. Conformity assessment bodies established under the law of a third country with which the Union has concluded an agreement may be authorised to carry out the activities of notified bodies under this Regulation, provided that they meet the requirements laid down
Harmonised standards and standardisation deliverables
El artículo 40 (Harmonised standards and standardisation deliverables) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Common specifications
El artículo 41 (Common specifications) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Presumption of conformity with certain requirements
El artículo 42 (Presumption of conformity with certain requirements) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Conformity assessment
El artículo 43 (Conformity assessment) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Certificates
El artículo 44 (Certificates) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Information obligations of notified bodies
El artículo 45 (Information obligations of notified bodies) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Derogation from conformity assessment procedure
El artículo 46 (Derogation from conformity assessment procedure) establece obligaciones y criterios operativos dentro del marco DORA. 1.
EU declaration of conformity
El artículo 47 (EU declaration of conformity) establece obligaciones y criterios operativos dentro del marco DORA. 1.
CE marking
El artículo 48 (CE marking) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Registration
El artículo 49 (Registration) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Transparency obligations for providers and deployers of certain AI systems
El artículo 50 (Transparency obligations for providers and deployers of certain AI systems) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Classification of general-purpose AI models as general-purpose AI models with systemic risk
El artículo 51 (Classification of general-purpose AI models as general-purpose AI models with systemic risk) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Procedure
El artículo 52 (Procedure) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Obligations for providers of general-purpose AI models
El artículo 53 (Obligations for providers of general-purpose AI models) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Authorised representatives of providers of general-purpose AI models
El artículo 54 (Authorised representatives of providers of general-purpose AI models) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Obligations of providers of general-purpose AI models with systemic risk
El artículo 55 (Obligations of providers of general-purpose AI models with systemic risk) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Codes of practice
El artículo 56 (Codes of practice) establece obligaciones y criterios operativos dentro del marco DORA. 1.
AI regulatory sandboxes
El artículo 57 (AI regulatory sandboxes) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Detailed arrangements for, and functioning of, AI regulatory sandboxes
El artículo 58 (Detailed arrangements for, and functioning of, AI regulatory sandboxes) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Further processing of personal data for developing certain AI systems in the public interest in the AI regulatory sandbox
El artículo 59 (Further processing of personal data for developing certain AI systems in the public interest in the AI regulatory sandbox) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes
El artículo 60 (Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Informed consent to participate in testing in real world conditions outside AI regulatory sandboxes
El artículo 61 (Informed consent to participate in testing in real world conditions outside AI regulatory sandboxes) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Measures for providers and deployers, in particular SMEs, including start-ups
El artículo 62 (Measures for providers and deployers, in particular SMEs, including start-ups) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Derogations for specific operators
El artículo 63 (Derogations for specific operators) establece obligaciones y criterios operativos dentro del marco DORA. 1.
AI Office
El artículo 64 (AI Office) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Establishment and structure of the European Artificial Intelligence Board
El artículo 65 (Establishment and structure of the European Artificial Intelligence Board) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Tasks of the Board
El artículo 66 (Tasks of the Board) establece obligaciones y criterios operativos dentro del marco DORA. The Board shall advise and assist the Commission and the Member States in order to facilitate the consistent and effective application of this Regulation.
Advisory forum
El artículo 67 (Advisory forum) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Scientific panel of independent experts
El artículo 68 (Scientific panel of independent experts) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Access to the pool of experts by the Member States
El artículo 69 (Access to the pool of experts by the Member States) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Designation of national competent authorities and single points of contact
El artículo 70 (Designation of national competent authorities and single points of contact) establece obligaciones y criterios operativos dentro del marco DORA. 1.
EU database for high-risk AI systems listed in Annex III
El artículo 71 (EU database for high-risk AI systems listed in Annex III) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Post-market monitoring by providers and post-market monitoring plan for high-risk AI systems
El artículo 72 (Post-market monitoring by providers and post-market monitoring plan for high-risk AI systems) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Reporting of serious incidents
El artículo 73 (Reporting of serious incidents) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Market surveillance and control of AI systems in the Union market
El artículo 74 (Market surveillance and control of AI systems in the Union market) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Mutual assistance, market surveillance and control of general-purpose AI systems
El artículo 75 (Mutual assistance, market surveillance and control of general-purpose AI systems) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Supervision of testing in real world conditions by market surveillance authorities
El artículo 76 (Supervision of testing in real world conditions by market surveillance authorities) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Powers of authorities protecting fundamental rights
El artículo 77 (Powers of authorities protecting fundamental rights) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Confidentiality
El artículo 78 (Confidentiality) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Procedure at national level for dealing with AI systems presenting a risk
El artículo 79 (Procedure at national level for dealing with AI systems presenting a risk) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Procedure for dealing with AI systems classified by the provider as non-high-risk in application of Annex III
El artículo 80 (Procedure for dealing with AI systems classified by the provider as non-high-risk in application of Annex III) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Union safeguard procedure
El artículo 81 (Union safeguard procedure) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Compliant AI systems which present a risk
El artículo 82 (Compliant AI systems which present a risk) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Formal non-compliance
El artículo 83 (Formal non-compliance) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Union AI testing support structures
El artículo 84 (Union AI testing support structures) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Right to lodge a complaint with a market surveillance authority
El artículo 85 (Right to lodge a complaint with a market surveillance authority) establece obligaciones y criterios operativos dentro del marco DORA. Without prejudice to other administrative or judicial remedies, any natural or legal person having grounds to consider that there has been an infringement of the provisions of this Regulation may submit complaints to the relevant market surveillance authority.
Right to explanation of individual decision-making
El artículo 86 (Right to explanation of individual decision-making) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Reporting of infringements and protection of reporting persons
El artículo 87 (Reporting of infringements and protection of reporting persons) establece obligaciones y criterios operativos dentro del marco DORA. Directive (EU) 2019/1937 shall apply to the reporting of infringements of this Regulation and the protection of persons reporting such infringements.
Enforcement of the obligations of providers of general-purpose AI models
El artículo 88 (Enforcement of the obligations of providers of general-purpose AI models) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Monitoring actions
El artículo 89 (Monitoring actions) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Alerts of systemic risks by the scientific panel
El artículo 90 (Alerts of systemic risks by the scientific panel) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Power to request documentation and information
El artículo 91 (Power to request documentation and information) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Power to conduct evaluations
El artículo 92 (Power to conduct evaluations) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Power to request measures
El artículo 93 (Power to request measures) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Procedural rights of economic operators of the general-purpose AI model
El artículo 94 (Procedural rights of economic operators of the general-purpose AI model) establece obligaciones y criterios operativos dentro del marco DORA. Article 18 of Regulation (EU) 2019/1020 shall apply mutatis mutandis to the providers of the general-purpose AI model, without prejudice to more specific procedural rights provided for in this Regulation.
Codes of conduct for voluntary application of specific requirements
El artículo 95 (Codes of conduct for voluntary application of specific requirements) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Guidelines from the Commission on the implementation of this Regulation
El artículo 96 (Guidelines from the Commission on the implementation of this Regulation) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Exercise of the delegation
El artículo 97 (Exercise of the delegation) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Committee procedure
El artículo 98 (Committee procedure) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Penalties
El artículo 99 (Penalties) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Administrative fines on Union institutions, bodies, offices and agencies
El artículo 100 (Administrative fines on Union institutions, bodies, offices and agencies) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Fines for providers of general-purpose AI models
El artículo 101 (Fines for providers of general-purpose AI models) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Amendment to Regulation (EC) No 300/2008
El artículo 102 (Amendment to Regulation (EC) No 300/2008) establece obligaciones y criterios operativos dentro del marco DORA. In Article 4(3) of Regulation (EC) No 300/2008, the following subparagraph is added: ‘When adopting detailed measures related to technical specifications and procedures for approval and use of security equipment concerning Artificial Intelligence systems withi
Amendment to Regulation (EU) No 167/2013
El artículo 103 (Amendment to Regulation (EU) No 167/2013) establece obligaciones y criterios operativos dentro del marco DORA. In Article 17(5) of Regulation (EU) No 167/2013, the following subparagraph is added: ‘When adopting delegated acts pursuant to the first subparagraph concerning artificial intelligence systems which are safety components within the meaning of Regulation (EU)
Amendment to Regulation (EU) No 168/2013
El artículo 104 (Amendment to Regulation (EU) No 168/2013) establece obligaciones y criterios operativos dentro del marco DORA. In Article 22(5) of Regulation (EU) No 168/2013, the following subparagraph is added: ‘When adopting delegated acts pursuant to the first subparagraph concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU)
Amendment to Directive 2014/90/EU
El artículo 105 (Amendment to Directive 2014/90/EU) establece obligaciones y criterios operativos dentro del marco DORA. In Article 8 of Directive 2014/90/EU, the following paragraph is added: ‘5.
Amendment to Directive (EU) 2016/797
El artículo 106 (Amendment to Directive (EU) 2016/797) establece obligaciones y criterios operativos dentro del marco DORA. In Article 5 of Directive (EU) 2016/797, the following paragraph is added: ‘12.
Amendment to Regulation (EU) 2018/858
El artículo 107 (Amendment to Regulation (EU) 2018/858) establece obligaciones y criterios operativos dentro del marco DORA. In Article 5 of Regulation (EU) 2018/858 the following paragraph is added: ‘4.
Amendments to Regulation (EU) 2018/1139
El artículo 108 (Amendments to Regulation (EU) 2018/1139) establece obligaciones y criterios operativos dentro del marco DORA. Regulation (EU) 2018/1139 is amended as follows: (1) in Article 17, the following paragraph is added: ‘3.
Amendment to Regulation (EU) 2019/2144
El artículo 109 (Amendment to Regulation (EU) 2019/2144) establece obligaciones y criterios operativos dentro del marco DORA. In Article 11 of Regulation (EU) 2019/2144, the following paragraph is added: ‘3.
Amendment to Directive (EU) 2020/1828
El artículo 110 (Amendment to Directive (EU) 2020/1828) establece obligaciones y criterios operativos dentro del marco DORA. In Annex I to Directive (EU) 2020/1828 of the European Parliament and of the Council ( 58 ) , the following point is added: ‘(68) Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial
AI systems already placed on the market or put into service and general-purpose AI models already placed on the marked
El artículo 111 (AI systems already placed on the market or put into service and general-purpose AI models already placed on the marked) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Evaluation and review
El artículo 112 (Evaluation and review) establece obligaciones y criterios operativos dentro del marco DORA. 1.
Entry into force and application
El artículo 113 (Entry into force and application) establece obligaciones y criterios operativos dentro del marco DORA. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .