High-risk · Article 6 · Annex III
Guidelines, consultations, examples and sources for classifying high-risk AI systems.
The AI Act requires providers and deployers of AI systems to implement measures for developing AI competence. AI competence includes understanding, skills and knowledge to use AI systems appropriately and minimize risks. The regulation does not prescribe standardized training or competence levels.
Source: Bundesnetzagentur
The document outlines the enforcement functions of the AI Office for GPAI models and AI systems. It clarifies responsibilities, investigative powers, sanctioning options, and monitoring tools. Enforcement begins on 2 August 2026.
Source: European Commission / European AI Office
On 19 June, the inaugural session of the AI Act Advisory Forum took place. The forum supports the implementation and enforcement of the AI Act, focusing on standardisation and classification of high-risk AI systems. It comprises 174 members from civil society, academia, and industry.
Source: European Commission
The Federal Network Agency prepares the implementation of the EU AI Act in Germany. The regulation governs AI systems based on risk, with strict requirements for transparency and safety at high risk levels. Effective from August 2027.
Source: Bundesnetzagentur
The European Commission provides draft guidelines on classifying high-risk AI systems under the AI Act. The document includes summaries and examples for AI systems in regulated products and sensitive areas.
Source: European Commission
The European Commission has appointed a Scientific Panel and an Advisory Forum to support enforcement of the AI Act. Both bodies advise the Commission's AI Office and national authorities on applying the rules. The Scientific Panel consists of 60 independent experts with experience in frontier AI, engineering, technical auditing, industry, and societal impact. The Advisory Forum provides independent technical expertise on issues such as standardisation and implementation challenges.
Source: European Commission
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 EU AI Act promotes trustworthy AI, protects health and fundamental rights, and establishes uniform rules. It applies to providers, operators, and distributors of AI systems from August 2, 2025. Deadlines and guidelines are defined until 2028.
Source: Bundesnetzagentur
The Federal Network Agency prepares the implementation of the EU AI Act in Germany. The regulation governs AI systems based on risk, with strict requirements for transparency and safety at high risk levels. Full applicability from August 2027.
Source: Bundesnetzagentur
The Commission has published draft guidelines for high-risk AI systems, based on stakeholder feedback. They help providers and users to classify AI systems and fulfill obligations. The guidelines are non-binding but guide implementation of the AI Act.
Source: European Commission
The European Commission is conducting a consultation until 23 July 2026 on draft guidelines for classifying high-risk AI systems. The goal is to assess the clarity, user-friendliness, and usefulness of the examples in the guidelines. The guidelines aim to support providers, deployers, and authorities in risk assessment.
Source: European Commission
The European Commission has published draft guidelines for classifying artificial intelligence (AI) as high-risk systems. These guidelines aim to help providers and users assess whether a system is classified as high-risk. The guidelines are part of the AI Act and will complement other guidelines for compliance with obligations for high-risk AI systems.
Source: European Commission
The European Commission has opened a consultation on draft guidelines for classifying high-risk AI systems. The goal is to assess the clarity and usefulness of the examples. The guidelines support providers, users, and market surveillance authorities in evaluating whether an AI system should be classified as high-risk. The deadline for feedback has been extended to 23 July 2026.
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 the criteria under Article 6 of the AI Act and provide practical examples.
Source: European Commission
The European Commission's draft guidelines assist providers and users 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 European Commission provides FAQs on implementing the EU AI Act. The regulation addresses risks to health, safety, and fundamental rights. It regulates prohibited AI systems, high-risk applications, transparency requirements, and general-purpose AI models.
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 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 for the practical application of high-risk classification and transparency requirements under the AI Act to support compliance and provide clear instructions for businesses.
Source: European Commission / European AI Office
The EU AI Board is a central advisory body for implementing the AI Act. It coordinates national strategies, supports enforcement, and promotes ethical AI development. The Board consists of representatives from EU Member States and is supported by the AI Office.
Source: European Commission / European AI Office
The European Commission is conducting multiple consultations on AI guidelines, including transparency obligations for AI systems and the use of AI in healthcare. Consultations run until September 2026.
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 EU AI Act establishes a legal framework with four risk levels to ensure AI safety and fundamental rights. It promotes innovation and trust through clear rules for developers and users. Implementation starts on 2 August 2026.
Source: European Commission / DG CONNECT
Article 7 of the EU AI Act empowers the European Commission to amend Annex III, which classifies high-risk AI systems. Amendments may be added, removed, or modified if certain criteria are met. This provision is part of the overall AI regulatory framework.
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 is either a safety component or listed in Annex III. Exceptions apply if no significant risk exists. Providers must document their assessment and provide it to authorities upon request.
Source: European Commission / AI Act Service Desk
Article 5 of the EU AI Act prohibits certain AI systems that violate fundamental rights, such as manipulative, exploitative, or social scoring practices. This includes AI systems for criminal risk assessment, untargeted data scraping for facial recognition, and real-time biometric identification in public spaces. Exceptions are possible if legal safeguards are followed.
Source: European Commission / AI Act Service Desk
Article 4 of the EU AI Act addresses AI literacy. Providers and deployers of AI systems must ensure their staff and third parties have sufficient knowledge. Measures must consider technical competence, experience, training, and the application context.
Source: European Commission / AI Act Service Desk
Article 3 of the EU AI Act defines key terms such as 'AI system', 'high-risk AI systems', and 'General-Purpose AI'. The definitions ensure consistent application of the regulation. The summaries are not legally binding.
Source: European Commission / AI Act Service Desk
The EU AI Act defines the scope for AI systems and general-purpose AI models. It applies to providers, users, and distributors in the EU market, excluding military use, research, and private use. Certain categories are excluded.
Source: European Commission / AI Act Service Desk
Article 1 of the EU AI Act defines the regulation's scope and objectives. It aims to create a unified market for trustworthy AI systems that protect health, safety, and fundamental rights while promoting innovation and consumer protection.
Source: European Commission / AI Act Service Desk
The FAQs address common questions on enforcement and governance of the EU AI Act. They cover the responsibilities of the AI Office, EDPS, and national authorities, the establishment of complaint and whistleblower tools, and the application of rules for GPAI models and high-risk AI systems.
Source: European Commission / AI Act Service Desk
The European Commission provides resources to support compliance with the EU AI Act, including fact sheets, guidelines, and webinars. The focus is on transparency obligations, codes of practice, and promoting AI literacy. Implementation begins on 2 August 2026.
Source: European Commission / AI Act Service Desk
The EU AI Act legislation is implemented progressively, with the full application of the main milestones by 2 August 2028. The timeline accounts for amendments introduced by the Digital Omnibus on AI.
Source: European Commission / AI Act Service Desk
The EU AI Act Explorer is a reference tool for the EU Artificial Intelligence Act. It allows users to search for prohibited practices, risk classifications, transparency obligations, and provider/deployer duties. The tool supports compliance with governance and data protection requirements.
Source: European Commission / AI Act Service Desk