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Your guide to the EU AI Act
Discover everything you need to know—all in one place.
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1. What is the EU AI Act?
The EU AI Act is the world’s first comprehensive legal framework for AI regulation. Developed by the European Commission, it aims to ensure AI systems used within the EU are safe, transparent, and aligned with fundamental rights.
At its core, the Act introduces a risk-based approach to regulating AI and assigns obligations accordingly. It applies not only to EU-based organizations but also to any entity using AI in interaction with EU residents.
3. Risk Classification Under the EU AI Act
At the heart of the EU AI Act is a risk-based regulatory framework that assigns AI systems to different risk categories based on their potential impact on individuals and society. This classification determines the legal obligations that apply to the system, making it the first and most critical step for any organization developing or using AI.
The three main vertical risk categories are:
Prohibited AI Systems
These systems pose an unacceptable risk and are banned under Article 5. Examples include:
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Subliminal manipulation of individuals beyond their awareness
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Exploitation of vulnerabilities due to age, disability, or social status
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Biometric categorization inferring sensitive data (e.g., ethnicity, religion)
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Social scoring by public authorities
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Real-time remote biometric identification in public spaces (with narrow law enforcement exceptions)
These practices are deemed incompatible with EU values. No compliance path exists unless specific exemptions apply
High-Risk AI Systems
If not prohibited, an AI system may be classified as high-risk if it falls into a listed use case in Annex III or is part of regulated products under EU harmonization legislation (Annex I). High-risk sectors include:
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Biometric identification and emotion recognition
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Critical infrastructure (e.g., energy, transport)
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Education and vocational training
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Employment, worker management
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Public services and social benefits
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Law enforcement and criminal justice
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Migration, asylum, and border control
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Judicial decision support
High-risk systems must meet detailed requirements covering risk management, data quality, oversight, and more.
Some systems in Annex III may be exempt if they only have limited functionality or indirect influence. However, profiling systems that use personal data are not eligible for exemption.
Minimal-Risk AI Systems
Systems that do not fall into the prohibited or high-risk categories are considered minimal-risk. These include most everyday applications such as AI-powered chatbots, recommendation engines, or spam filters. They are not subject to mandatory regulation but may voluntarily follow codes of conduct to promote responsible AI development.
In addition to the tiered risk classification, the EU AI Act imposes horizontal requirements that apply regardless of the system’s risk level. These ensure a baseline of trust, transparency, and accountability in AI development and deployment:
Horizontal Requirements: Obligations Across All Risk Levels
1. Transparency Obligations
Certain systems must inform users that they are interacting with AI—even if they are minimal-risk. These obligations apply to:
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Conversational AI (e.g., chatbots)
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Synthetic content generators (e.g., deepfakes, AI-generated media)
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Emotion recognition and biometric categorization systems
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Publicly available AI-generated text or content
Failure to meet these obligations can mislead users and result in enforcement actions, even if the system is otherwise low-risk.
2. AI Literacy
Providers and deployers must promote AI literacy among staff and affected individuals. This includes training users to understand system capabilities, risks, and appropriate use—particularly where AI impacts decision-making or user rights.
2. Who is Affected: Roles & Responsibilites
The EU AI Act defines five key roles in the AI system lifecycle, each with tailored responsibilities:
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Providers: Entities that develop, train, or market AI systems. They hold the most extensive obligations.
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Deployers: Organizations that use AI systems in their operations.
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Importers: Entities that bring AI systems from outside the EU into the EU market.
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Distributors: Those who make AI systems available without modifying them.
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Authorized Representatives: EU-based entities representing non-EU providers.
Understanding your role is the first step toward compliance. Each role carries specific duties for documentation, monitoring, and accountability.
4. Key Compliance Requirements of the EU AI Act
The EU AI Act outlines a set of obligations for high-risk AI systems, including the following:
Risk Management System
Implement a continuous, documented process to identify, analyze, and mitigate risks to health, safety, fundamental rights, and the environment throughout the AI system’s lifecycle.
Data and Data Governance
Use training, validation, and testing datasets that are relevant, representative, complete, and free of errors. Address bias and ensure data integrity and traceability
Technical Documentation
Maintain up-to-date documentation explaining the system’s purpose, design, development process, and compliance measures to support regulatory oversight
Record-Keeping / Logging
Ensure the system automatically logs events during operation to support traceability, error investigation, and auditability. Retain logs securely.
Transparency and User Information
Provide users with clear instructions on system capabilities, limitations, expected performance, and appropriate use, including human oversight details.
Human Oversight
Design the system to allow meaningful human control or intervention during operation to prevent or minimize risks.
Accuracy, Robustness, and Cybersecurity
Ensure the system performs reliably under normal and stressful conditions, resists attacks, and includes fallback procedures in case of faults.
Quality Management System (QMS)
Establish and maintain a QMS that covers compliance procedures, design controls, data handling, testing, updates, and continuous improvement.
Conformity Assessment
Carry out an internal or external conformity assessment to verify that the system meets EU AI Act requirements before market placement.
CE Marking and Declaration of Conformity
Issue a declaration confirming compliance and affix the CE marking before placing the system on the EU market.
Post-Market Monitoring
Monitor the system’s performance after deployment to identify new risks, ensure continued compliance, and update documentation as needed.
Data and Data Governance
Use training, validation, and testing datasets that are relevant, representative, complete, and free of errors. Address bias and ensure data integrity and traceability
Incident Reporting
Report serious incidents or system malfunctions to authorities without undue delay and take corrective action.
EU Database Registration
Register the high-risk AI system in the EU’s public database before placing it on the market or putting it into use.
Aligning with international standards like ISO/IEC 42001 and ISO/IEC 42005 can help organizations implement these requirements systematically. It supports structured risk management, governance, transparency, and continuous improvement—essential elements of sustainable compliance.
Using ISO/IEC 42001 and ISO/IEC 42005 doesn’t guarantee compliance but helps you operationalize obligations at scale, demonstrate due diligence, and prepare for audits or conformity assessments more effectively.
5. Penalties for Non-Compliance
To enforce the regulation, the EU AI Act empowers national market surveillance authorities to issue significant penalties for non-compliance. Fines are based on the severity of the violation and can be calculated either as a fixed amount or a percentage of global annual turnover — whichever is higher:
Non compliance with prohibited AI practices:
€35M
or 7% of global revenue,
whichever is higher
Breaches of other compliance obligations:
€15M
or 3% of global revenue,
whichever is higher
Supplying false or misleading information:
€7.5M
or 1.5% of global revenue,
whichever is higher
6. Timeline: When the EU AI Act Takes Effect
Understanding the EU AI Act timeline is critical for planning your compliance strategy. Timing might still look convenient but be aware that there are a lot of organizational requirements which need to be met and esp. those take their time. It's recommended not to wait too long. The Act officially entered into force on 1 August 2024. By 2 February 2025, all providers and deployers of AI systems needed to ensure, to their best extent, a sufficient level of AI literacy among staff dealing with the operation and use of AI systems. The Act will become fully applicable in August 2026, except for specific provisions.
7. Benefits of Complying
The AI Act is a game-changer for anyone working with artificial intelligence. Compliant organizations will be seen as responsible and forward-thinking leaders in the AI space. Being able to present compliance both to internal (e.g. applicants) and external groups (like investors, clients, suppliers, etc.) can become a differentiator. Demonstrating compliance can be achieved by official standards/certification but also providing a self-assessment supported via a comprehensive tool/platform is a good building block.
Build Trust
Show your AI systems are safe, transparent, and accountable.
Reduce Risk
Minimize legal and reputational exposure with strong oversight.
Stay Compliant
Ensure alignment with EU law and global regulations.
Strengthen Market Position
Enhance your competitiveness in the European AI landscape.
Boost Confidence
Increase confidence among customers and stakeholders.
Future-Proof AI
Establish governance that supports long-term innovation.
8. How Validaitor Helps
The EU AI Act is complex, but Validaitor makes it manageable. Our platform is built to help you meet regulatory demands like the EU AI Act at any stage of your AI journey without slowing innovation.
For end-to-end support, explore our Validaitor Ecosystem—a network of expert partners offering implementation, integration, legal, and training services to help you operationalize Trustworthy AI and stay compliant with the EU AI Act.
Start today and turn regulation into a Competitive Advantage.
9. Resources
Our EU AI Act resource hub offers practical guides and expert insights to help you understand the regulation and meet your compliance obligations with confidence.
