CEN/CENELEC · standards · conformity

Standards, harmonised norms and conformity

Sources on harmonised standards, standardisation, quality management and conformity assessment.

38 documents Last update: 2026-10-05T18:18:58Z
StandardisationDE

AI Competence under EU AI Act

According to the EU AI Act, providers and users of AI systems must implement measures to develop AI competence among their staff. AI competence includes understanding, critical evaluation, and responsible use of AI. The regulation does not prescribe standardized training or specific competence levels.

Source: Bundesnetzagentur

High-risk AI AI literacy Standards Governance

LawEU

EU AI Act: Annex III on Risk Classification and Requirements

Annex III of the EU AI Act defines criteria for classifying AI systems as high-risk and sets detailed requirements for their development, deployment, and monitoring. It includes 83 specific articles covering risk management, data governance, transparency obligations, and conformity assessment procedures.

Source: European Commission

High-risk AI Standards Governance Data protection

GuidelineEU

EU AI Act: Advisory Forum Kick-Off

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

High-risk AI Transparency Standards Governance

ResourceDE

Federal Network Agency - AI Act

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

Transparency GPAI AI literacy Standards

StandardisationEU

EU Commission appoints expert panels for AI Act

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

High-risk AI GPAI AI literacy Standards

LawEU

EDPB-EDPS Joint Opinion on the European Biotech Act

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

High-risk AI AI literacy Standards Data protection

LawEU

EDPB Annual Report 2025 on the Support Pool of Experts

The EDPB 2025 Annual Report summarises the activities of the Support Pool of Experts (SPE), including completed projects on AI risks, data protection enforcement, and technological tools. The report highlights transparency and cooperation between supervisory authorities.

Source: European Data Protection Board

Transparency Standards Governance Germany

StandardisationDE

BSI: Artificial Intelligence and IT Security

The German Federal Office for Information Security (BSI) examines security aspects of artificial intelligence (AI) and develops evaluation criteria. The focus is on robustness, transparency and explainability of AI systems and their application in security-critical areas.

Source: Bundesamt für Sicherheit in der Informationstechnik

Transparency AI literacy Standards Germany

StandardisationDE

Transparency Requirements for AI Systems

The Federal Network Agency explains transparency requirements for AI systems. Providers and deployers must meet specific requirements depending on the application, such as labeling synthetic content or informing affected individuals. Exceptions apply, for example, for criminal law purposes.

Source: Bundesnetzagentur

Transparency GPAI AI literacy Standards

ResourceDE

Risk Levels of the AI Act

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

Prohibited practices High-risk AI Transparency GPAI

ResourceDE

Federal Network Agency - AI Act

The Federal Network Agency prepares the implementation of the EU AI Act in Germany. The regulation governs AI systems on a risk-based approach, with strict requirements for transparency and safety at high risk. Effective from August 2027.

Source: Bundesnetzagentur

Transparency GPAI AI literacy Standards

GuidelineEU

EU Consultation on Guidelines for High-Risk AI Systems

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

High-risk AI Transparency Standards Governance

GuidelineEU

Draft Commission Guidelines on Classification of High-Risk AI Systems

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

High-risk AI Standards Governance

GuidelineEU

EU AI Act: Navigating the AI Act FAQ

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

Prohibited practices High-risk AI Transparency GPAI

Code of PracticeEU

EU AI Act: Transparency Code of Practice – Third and Final Draft

The European Commission has published the third and final draft of the Transparency Code of Practice under the EU AI Act. The code regulates the marking and disclosure of AI-generated content. Stakeholders across the AI value chain discussed technical and legal aspects during working group meetings and workshops.

Source: European Commission

Transparency Standards Governance

Code of PracticeEU

EU AI Act: Harmonised Standards for AI Systems

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

High-risk AI Transparency GPAI AI literacy

ConsultationEU

prEN 18286 Reaches Enquiry Stage: Milestone for AI Quality Management in Europe

The proposed European standard prEN 18286 for AI quality management has reached the Enquiry stage. It aims to ensure conformity with the EU AI Act and will be publicly consulted in all CEN member countries. National bodies have 12 weeks to vote and submit comments.

Source: European Commission

Standards Governance Germany

StandardisationEU

Standardisation of the AI Act

The European Commission promotes harmonized standards for high-risk AI systems to ensure legal certainty and set global benchmarks. CEN and CENELEC are developing standards in ten key areas, including risk management and transparency. The first harmonized standard was published on October 30, 2025.

Source: European Commission

High-risk AI Transparency Standards Governance

StandardisationEU

Standardisation of the EU AI Act

The European Commission promotes harmonised standards for high-risk AI systems to ensure legal certainty and support innovation. These standards translate legal requirements into technical language, helping companies comply with the AI Act.

Source: European Commission

High-risk AI Transparency Standards Governance

GuidelineEU

EU AI Act: FAQs on General-Purpose AI Models

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

High-risk AI Transparency GPAI AI literacy

Code of PracticeEU

EU launches first General-Purpose AI Code of Practice

The EU initiates the development of the first General-Purpose AI Code of Practice with four working groups on transparency, copyright rules, risk identification, technical risk mitigation, and internal risk management. Experts from academia, industry, and civil society will collaborate until April 2025 to create a comprehensive framework.

Source: European Commission / AI Office

Transparency GPAI Standards Governance

GuidelineEU

EU Code of Practice for General-Purpose AI

The voluntary General-Purpose AI Code of Practice supports providers in complying with AI Act requirements on transparency, safety, and copyright. Published on July 10, 2025, it consists of three chapters.

Source: European Commission / AI Office

Transparency GPAI Standards Governance

GuidelineEU

EU AI Board: Governance and Coordination

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

High-risk AI Transparency GPAI AI literacy

ResourceEU

European AI Office Established

The Commission decided to establish a European AI Office within the Commission. The office will be under the Directorate-General for Communication Networks, Content and Technology and subject to its annual management plan. It aims to provide guidance and complement AI system oversight without affecting existing responsibilities.

Source: European Commission / European AI Office

Standards Governance

GuidelineEU

European AI Office

The European AI Office supports the development and adoption of trustworthy AI solutions while protecting citizens from risks. It is responsible for implementing the AI Act, particularly for GPAI models, and promotes international cooperation.

Source: European Commission / European AI Office

Transparency GPAI AI literacy Standards

GuidelineEU

European Approach to Artificial Intelligence

The EU promotes research and industrial AI capacity while ensuring safety and fundamental rights. The AI Act establishes a four-tier risk framework. Initiatives like AI Factories and InvestAI support innovation and investments.

Source: European Commission / DG CONNECT

Prohibited practices High-risk AI Transparency GPAI

LawEU

EU AI Act: First Comprehensive AI Regulatory Framework

The EU AI Act is the first comprehensive legal framework for AI, addressing risks and positioning Europe as a global tech leader. It defines four risk levels, bans certain AI practices, and imposes strict requirements for high-risk systems. The Act comes into force gradually from 2025.

Source: European Commission / DG CONNECT

Prohibited practices High-risk AI Transparency GPAI

LawEU

AI Act: Amendments to Annex III

Article 7 of the EU AI Act empowers the European Commission to amend Annex III by adding, removing, or modifying high-risk AI system use cases. Changes are subject to specific criteria and conditions outlined in the regulation.

Source: European Commission / AI Act Service Desk

High-risk AI Standards

LawEU

EU AI Act: Classification Rules for High-Risk AI Systems

Article 6 of the EU AI Act defines criteria for classifying AI systems as high-risk. An AI system is considered high-risk if it is used as a safety component of a product requiring third-party conformity assessment or listed in Annex III. Exceptions apply under specific conditions.

Source: European Commission / AI Act Service Desk

High-risk AI Standards Governance Data protection

LawEU

AI Act: Article 5 – Prohibited AI Practices

Article 5 of the EU AI Act prohibits AI systems that violate fundamental rights, such as manipulative techniques, exploitation of vulnerabilities, social scoring, and real-time remote biometric identification. Two additional prohibitions apply from 2 December 2026.

Source: European Commission / AI Act Service Desk

Prohibited practices High-risk AI Transparency GPAI

LawEU

EU AI Act: Article 2 - Scope

Article 2 of the EU AI Act defines the scope of the regulation. It specifies who is subject to the regulation when offering, deploying, importing, or distributing AI systems or general-purpose AI models within the EU. Military applications, research activities, and natural persons using AI for personal purposes are excluded.

Source: European Commission / AI Act Service Desk

High-risk AI Transparency GPAI Standards

LawEU

EU AI Act: Article 1 - Subject Matter

Article 1 of the EU AI Act defines the regulation's subject matter. It establishes the objective to improve the internal market and promote trustworthy AI while protecting fundamental rights and safety. The regulation sets harmonised rules for AI systems.

Source: European Commission / AI Act Service Desk

Prohibited practices High-risk AI Transparency GPAI

ResourceEU

EU AI Act National Resources

The document lists national resources and contact points for implementing the EU AI Act in various countries. It names the competent authorities in Cyprus, Italy, Belgium, Austria, Lithuania, Luxembourg, Germany, and the Netherlands.

Source: European Commission / AI Act Service Desk

Standards Governance Germany

GuidelineEU

EU AI Act: Service Desk Resources

The European Commission provides resources for the EU AI Act, including guidelines, webinars, and templates. These materials support providers and users of AI systems in complying with legal requirements.

Source: European Commission / AI Act Service Desk

Prohibited practices Transparency GPAI Standards

GuidelineEU

EU AI Act: Resources for Transparency and Compliance

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

Prohibited practices High-risk AI Transparency GPAI

LawEU

EU AI Act Explorer by European Commission

The AI Act Explorer by the European Commission is a reference tool for the EU AI Act (Regulation (EU) 2024/1689). It enables searching for prohibited practices, risk classifications, transparency obligations, and requirements for AI systems. The document has been supplemented by the Digital Omnibus Regulation (EU 2026/1744).

Source: European Commission / AI Act Service Desk

Prohibited practices High-risk AI Transparency GPAI

ResourceEU

EU AI Act: Single Information Platform for AI Regulation

The EU AI Act, effective from August 1, 2024, establishes harmonized rules for trustworthy AI. The Single Information Platform supports providers and users in complying with regulations through interactive tools like the Compliance Checker and AI Act Explorer.

Source: European Commission / AI Act Service Desk

GPAI Standards Governance Germany

LawEU

EU AI Act 2024/1689: Harmonized AI Regulation

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 regulates high-risk AI systems, protects personal data, and promotes trustworthy, human-centric AI.

Source: EUR-Lex / Europäische Union

High-risk AI Standards Germany Data protection