Article 39: Conformity Assessment Bodies of Third Countries
Conformity assessment bodies established under the law of a third country with which the Union has concluded an agreement may
Article 40: Harmonised Standards and Standardisation Deliverables
Summary of Article 40 * Presumption of Conformity with Standards: High-risk AI systems or general-purpose AI models conforming to harmonised standards
Article 41: Common Specifications
Summary of Article 41 * Adoption of Common Specifications: The Commission may establish common specifications for regulatory requirements if harmonised standards
Article 42: Presumption of Conformity with Certain Requirements
1. High-risk AI systems that have been trained and tested on data reflecting the specific geographical, behavioural, contextual or functional
Article 43: Conformity Assessment
Summary of Article 43 * Conformity Assessment Procedures for High-Risk AI Systems: Providers of high-risk AI systems in Annex III, point
Article 44: Certificates
Summary of Article 44 * Language and Accessibility of Certificates: Certificates issued by notified bodies must be in a language easily
Article 45: Information Obligations of Notified Bodies
Summary of Article 45 * Communication with Notifying Authorities: Notified bodies must inform notifying authorities about issued, refused, withdrawn, or modified
Article 46: Derogation from Conformity Assessment Procedure
Summary of Article 46 * Derogations for Exceptional Circumstances: Market surveillance authorities may authorise the temporary use of high-risk AI systems
Article 47: EU Declaration of Conformity
Summary of Article 47 * Provider’s Responsibilities: Providers must create, sign, and maintain a machine-readable EU declaration of conformity for
Article 48: CE Marking
Summary of Article 48 * General and Visibility Requirements: CE marking must follow the general principles of Regulation (EC) No 765/
Article 49: Registration
Summary of Article 49 * Responsibilities of Providers and Authorised Representatives: Providers and authorised representatives must register themselves and their high-risk
Article 50: Transparency Obligations for Providers and Deployers of Certain AI Systems
Summary of Article 50 * Responsibilities of Providers: Providers must ensure that AI systems interacting with natural persons disclose their AI
Article 51: Classification of General-Purpose AI Models as General-Purpose AI Models with Systemic Risk
Summary of Article 51 * Classification of Systemic Risk in General-Purpose AI Models: General-purpose AI models must be classified as having
Article 52: Procedure
Summary of Article 52 * Provider's Role in Notification and Initial Assessment: Providers of general-purpose AI models meeting the
Article 53: Obligations for Providers of General-Purpose AI Models
Summary of Article 53 * Responsibilities of Providers of General-Purpose AI Models: Providers must maintain technical documentation, share necessary information with
Article 54: Authorised Representatives of Providers of General-Purpose AI Models
Summary of Article 54 * Provider's Role in Authorised Representatives: Providers in third countries must appoint and enable an
Article 55: Obligations for Providers of General-Purpose AI Models with Systemic Risk
Summary of Article 55 * Provider’s Role in Evaluating and Mitigating Systemic Risks: Providers must conduct state-of-the-art model evaluations, including
Article 56: Codes of Practice
Summary of Article 56 * Development and Scope of Codes of Practice: The AI Office facilitates the creation of codes of
Article 57: AI Regulatory Sandboxes
Summary of Article 57 * Establishment and Structure of AI Sandboxes: AI sandboxes are established at national, regional, or Union levels
Article 58: Detailed Arrangements for, and Functioning of, AI Regulatory Sandboxes
Summary of Article 58 * Establishment and Eligibility of AI Regulatory Sandboxes: The Commission shall define detailed arrangements for the establishment,
Article 59: Further Processing of Personal Data for Developing Certain AI Systems in the Public Interest in the AI Regulatory Sandbox
Summary of Article 59 * Data Processing Eligibility and Safeguards: Personal data can be processed in AI sandboxes only for substantial
Article 60: Testing of High-Risk AI Systems in Real World Conditions Outside AI Regulatory Sandboxes
Summary of Article 60 * Provider Responsibilities for Planning and Registration: Providers must create a real-world testing plan, seek approval from
Article 61: Informed Consent to Participate in Testing in Real World Conditions Outside AI Regulatory Sandboxes
Summary of Article 61 * Provider Responsibilities for Consent Procedures: Providers must obtain freely-given informed consent from subjects prior to testing,
Article 62: Measures for Providers and Deployers, in Particular SMEs, Including Start-Ups
Summary of Article 62 * Support for SMEs and Start-Ups by Member States: Member States must ensure priority access for SMEs
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