High-risk · Article 6 · Annex III
Guidelines, consultations, examples and sources for classifying high-risk AI systems.
The EDPB and EDPS provide joint recommendations on data protection aspects of the European Biotech Act proposal. The proposal aims to strengthen the biotechnology industry while ensuring GDPR compliance in clinical trials and AI use.
Source: European Data Protection Board
The AI Act categorizes AI systems into four risk levels: unacceptable risk (banned), high risk (strictly regulated), limited risk (transparency obligations), and minimal risk (unregulated). High-risk systems require conformity assessments, while manipulative or surveillance systems are banned from 2025.
Source: Bundesnetzagentur
The AI Act promotes trustworthy AI in the EU, protects health and fundamental rights, and establishes uniform regulations. It applies to companies, authorities, and organizations using or developing AI. Regulations will be implemented gradually between February 2025 and August 2027.
Source: Bundesnetzagentur
The Federal Network Agency provides information on the EU AI Act, which regulates AI development and use in the EU. The Act will be fully applied in stages from August 2027. Companies can learn about risk classification, transparency requirements, and the AI Compliance Compass.
Source: Bundesnetzagentur
The Commission has published draft guidelines on classifying AI systems as high-risk under the AI Act. Based on stakeholder feedback, they aim to facilitate compliance with obligations. The guidelines are non-binding but will guide enforcement. A consultation process runs until 23 June 2026.
Source: European Commission
The European Commission is conducting a consultation until 23 June 2026 on draft guidelines for classifying high-risk AI systems. The aim is to clarify the application of the AI Act and provide practical examples.
Source: European Commission
The European Commission has published draft guidelines on the classification of artificial intelligence (AI) as high-risk systems. These guidelines aim to help providers and users assess whether a system is classified as high-risk. High-risk systems are those that could endanger health, safety, or fundamental rights.
Source: European Commission
The EU Commission is consulting until 23 June 2026 on draft guidelines for classifying high-risk AI systems. The guidelines aim to help providers and deployers assess whether an AI system falls into the high-risk category. They include clarifications on relevant AI Act provisions and practical examples.
Source: European Commission
The EU Commission's draft guidelines assist providers, deployers and authorities in assessing whether an AI system qualifies as high-risk. They explain criteria under Article 6 of the AI Act and provide practical examples.
Source: European Commission
The European Commission's draft guidelines assist providers and deployers of AI systems and market surveillance authorities in assessing whether an AI system should be classified as high-risk. They include practical examples and explain criteria under Article 6 of the EU AI Act.
Source: European Commission
The EU AI Act is the world's first comprehensive AI regulation. It addresses risks to health, safety, and fundamental rights. The FAQ guide explains the scope, prohibited practices, high-risk systems, transparency requirements, and governance. It helps businesses and authorities understand and comply with the regulations.
Source: European Commission
The European Commission promotes harmonised standards for the EU AI Act to simplify compliance. These standards, developed by CEN, CENELEC, and ETSI, will be published from 2026 onwards. They provide legal certainty for providers of high-risk AI systems.
Source: European Commission
CEN-CENELEC JTC 21 is a European technical committee developing standardization deliverables for AI technologies. Its goal is to create harmonized standards aligned with the EU AI Act, enabling manufacturers to achieve presumed conformity.
Source: European Commission
The European Commission promotes harmonised standards for AI systems to ensure legal certainty and support innovation. These standards help companies comply with the EU AI Act, particularly for high-risk applications.
Source: European Commission
The European Commission provides FAQs on general-purpose AI models in the EU AI Act. It explains definitions, risks, obligations for providers, and transition periods. The focus is on transparency, copyright, and risk assessment.
Source: European Commission
The European Commission is preparing guidelines to support the implementation of the AI Act, promoting compliance and innovation. These include practical instructions on high-risk classification, transparency requirements, and incident reporting.
Source: European Commission / European AI Office
The European Commission is conducting multiple consultations covering copyright, health data, AI service interoperability, energy efficiency of AI models, and the Digital Fairness Act. These consultations aim to gather feedback for shaping future regulations.
Source: European Commission / European AI Office
The European Commission has published guidelines on the definition of AI systems to facilitate the application of the first rules of the EU AI Act. The guidelines are non-binding and intended to evolve based on practical experiences.
Source: European Commission / DG CONNECT
The European Commission has published guidelines on prohibited AI practices under the AI Act. The guidelines clarify unacceptable practices such as harmful manipulation, social scoring, and real-time remote biometric identification. They aim to ensure consistent application of the AI Act across the EU.
Source: European Commission / DG CONNECT
The European Commission has presented a comprehensive approach to regulating artificial intelligence, promoting excellence and trust. The AI Act creates a risk framework with four levels and establishes clear rules for developers, users and deployers. Complementary initiatives such as the AI Continent Action Plan and the Apply AI Strategy promote innovation and investments.
Source: European Commission / DG CONNECT
The EU promotes the development and use of safe and trustworthy AI systems. The AI Act follows a risk-based approach to enable innovation while ensuring safety. Complementary strategies such as the Apply AI Strategy and the AI Continent Action Plan strengthen Europe's technological sovereignty and competitiveness.
Source: European Commission / DG CONNECT
The EU AI Act is the first comprehensive global regulatory framework for AI. It addresses risks and promotes trustworthy AI in Europe. The risk-based approach distinguishes four risk levels, prohibits certain practices, and imposes strict requirements for high-risk systems. The regulation entered into force on 1 August 2024 and will be fully applicable in two years.
Source: European Commission / DG CONNECT
Article 7 of the EU AI Act empowers the European Commission to update Annex III by adding, removing, or modifying use cases of high-risk AI systems under specific conditions outlined in the regulation.
Source: European Commission / AI Act Service Desk
Article 6 of the EU AI Act defines criteria for classifying AI systems as high-risk. A system is considered high-risk if it serves as a safety component or is listed in Annex III, unless it meets exceptions under paragraph 3. The Commission will publish guidelines for practical implementation by 2026.
Source: European Commission / AI Act Service Desk
Article 5 of the EU AI Act prohibits AI practices that violate fundamental rights, such as manipulative, exploitative, or social scoring systems. It also bans AI systems for real-time remote biometric identification in public spaces for law enforcement, except under urgent exceptions.
Source: European Commission / AI Act Service Desk
Article 4 of the EU AI Act sets out obligations for AI literacy among providers and deployers of AI systems. They must ensure that their staff and third parties have sufficient knowledge based on their education, experience, and the application context.
Source: European Commission / AI Act Service Desk
Article 3 of the EU AI Act defines key terms used throughout the regulation. These definitions clarify AI systems, prohibited practices, high-risk applications, and transparency requirements. They form the basis for consistent application of the law.
Source: European Commission / AI Act Service Desk
The EU AI Act applies to all who offer, use, or market AI systems or general-purpose AI models in the EU market. Military applications, research, and private use are excluded. The scope is defined in Article 2 of the AI Act.
Source: European Commission / AI Act Service Desk
Article 1 of the EU AI Act defines the regulation's objective: protecting health, safety, and fundamental rights while promoting trustworthy, human-centric AI. It establishes the scope and principles for regulating AI systems in the EU.
Source: European Commission / AI Act Service Desk
The AI Act Service Desk FAQs address key questions on the EU AI Act amendments, risk categorization, transparency obligations, and governance. Targeted at providers and users of AI systems.
Source: European Commission / AI Act Service Desk
The European Commission provides resources such as guidelines, webinars, and templates for the EU AI Act, including stakeholder consultations, a whistleblower tool, and technical guidance for GPAI providers.
Source: European Commission / AI Act Service Desk
The EU AI Act is implemented progressively, with full rollout by August 2027. Key milestones include transparency rules, general-purpose AI regulations, and high-risk systems. Member states must appoint national authorities and adapt penalty laws.
Source: European Commission / AI Act Service Desk
The AI Act Explorer by the European Commission is an interactive platform for navigating the EU Artificial Intelligence Act (Regulation (EU) 2024/1689). It enables users to search for prohibited practices, risk classifications, transparency obligations, general-purpose AI models, and enforcement mechanisms. The structure by chapters, articles, and annexes supports legal professionals and businesses in complying with the regulations.
Source: European Commission / AI Act Service Desk
Regulation (EU) 2024/1689 establishes harmonized rules for artificial intelligence to strengthen the internal market and ensure a high level of protection for health, safety, and fundamental rights. It governs high-risk AI systems, protects personal data, and promotes trustworthy AI.
Source: EUR-Lex / Europäische Union
