May 2, 2025
Arelis AI
A Comprehensive Guide to EU AI Act Compliance
Learn how to navigate the complex requirements of the EU AI Act and ensure your AI systems are compliant.

The European Union is pioneering the future of artificial intelligence regulation with the EU AI Act, the world's first comprehensive legal framework for AI. As businesses and organizations increasingly integrate AI into their operations, understanding and adhering to this landmark legislation is no longer optional—it's critical.
Important: Non-compliance can lead to hefty fines and significant reputational harm, making proactive preparation essential.
This guide will walk you through the key aspects of the EU AI Act, helping you navigate its complexities and ensure your AI systems are compliant.
Understanding the Risk-Based Approach
At the heart of the EU AI Act is a risk-based approach. This means that the level of regulation an AI system faces is directly proportional to the potential risk it poses to individuals' safety, fundamental rights, and societal well-being.
The Act categorizes AI systems into four distinct tiers:
Unacceptable Risk
These are AI systems deemed to pose a clear and unacceptable threat to the safety, livelihoods, or fundamental rights of people. Such systems are prohibited under the Act.
Examples include:
- •Social scoring systems by public authorities
- •Real-time remote biometric identification systems in publicly accessible spaces for law enforcement purposes (with narrow exceptions)
- •AI systems that manipulate human behavior to circumvent users' free will (e.g., toys using voice assistance encouraging dangerous behavior in minors)
- •AI systems exploiting vulnerabilities of specific groups (due to age, physical or mental disability) to materially distort their behavior in a manner that causes or is likely to cause harm
High Risk
This category includes AI systems that could adversely impact safety or fundamental rights. These systems aren't banned but are subject to stringent requirements before they can be put on the market and throughout their lifecycle.
Examples include AI systems used in:
- •Critical infrastructure (e.g., transport, energy)
- •Educational or vocational training (e.g., scoring exams)
- •Employment, workers management, and access to self-employment (e.g., CV-sorting software)
- •Essential private and public services (e.g., credit scoring, applications for social benefits)
- •Law enforcement (e.g., evaluation of evidence)
- •Migration, asylum, and border control management (e.g., verification of travel documents)
- •Administration of justice and democratic processes
Limited Risk
AI systems in this category, such as chatbots or AI-generated content (deepfakes), must adhere to specific transparency obligations.
Key requirement: Users need to be clearly informed that they are interacting with an AI system or that content has been artificially generated or manipulated, allowing them to make informed decisions.
Minimal Risk
The vast majority of AI systems are expected to fall into this category. These applications, like AI-enabled video games or spam filters, present minimal or no risk to citizens' rights or safety.
The Act allows for their free use, though providers may voluntarily commit to codes of conduct.
Key Compliance Requirements for High-Risk AI Systems: A Deep Dive
Given their potential impact, AI systems classified as "High-Risk" are subject to a comprehensive set of obligations under the EU AI Act. Organizations developing or deploying these systems must rigorously implement the following before placing them on the market or putting them into service:
- •
Risk Management Systems: This is a foundational requirement. Organizations must establish, implement, document, and maintain a continuous, iterative risk management system throughout the AI system's entire lifecycle. This involves identifying, analyzing, evaluating, and treating potential risks posed by the AI system, including those that could emerge after it's deployed.
- •
Data Governance and Management: The quality of data used to train, validate, and test high-risk AI systems is paramount. This requirement mandates robust practices for data governance, ensuring that datasets are:
- •
Relevant and Representative: Datasets must be appropriate for the intended purpose and reflect the populations and contexts where the AI will be used.
- •
Free from Errors and Complete: Measures must be taken to detect and correct errors and ensure data completeness.
- •
Appropriate in relation to the intended purpose: Data collection and processing practices must be examined for potential biases, and measures taken to mitigate them.
- •
- •
Technical Documentation: Comprehensive technical documentation must be drawn up before the system is placed on the market or put into service. This documentation must demonstrate that the high-risk AI system complies with the Act's requirements. It should detail the system's development process, its general characteristics, capabilities, limitations, conformity assessment procedures, and the measures put in place to ensure compliance.
- •
Record-Keeping (Logging): High-risk AI systems must be designed and developed with capabilities that enable the automatic recording of events ("logs") while the system is operating. These logs are crucial for tracing the system's operational history, monitoring its performance, and enabling post-incident investigations to verify compliance.
- •
Transparency and Provision of Information to Users: Users of high-risk AI systems must be provided with clear, concise, and intelligible information about the system. This includes its intended purpose, its level of accuracy, robustness, and cybersecurity, its capabilities and limitations, and any known or foreseeable risks. This transparency empowers users to understand and interact with the system appropriately.
- •
Human Oversight: Meaningful human oversight is a critical safeguard. High-risk AI systems must be designed and developed in such a way that they can be effectively overseen by natural persons during the period the AI system is in use. This includes measures that allow humans to understand the system's decisions, intervene if necessary, or even decide not to use the system in particular situations.
- •
Accuracy, Robustness, and Cybersecurity: High-risk AI systems must achieve an appropriate level of accuracy, robustness, and cybersecurity throughout their lifecycle.
- •
Accuracy: Systems must perform consistently and correctly for their intended purpose.
- •
Robustness: They must be resilient to errors, faults, or inconsistencies that may occur within the system or the environment in which it operates.
- •
Cybersecurity: They must be resilient against attempts to alter their use or performance by malicious third parties exploiting system vulnerabilities.
- •
Practical Steps for Compliance: Your Roadmap to Adherence
Navigating the EU AI Act requires a structured and proactive approach. Here are practical steps organizations should take to prepare for and maintain compliance, particularly for systems that may be classified as high-risk:
- •
Conduct an AI Inventory: The first step is to gain a comprehensive understanding of all AI systems currently in use, under development, or planned for future deployment within your organization. This inventory should include details about each system's purpose, data sources, development stage, and operational context.
- •
Perform Risk Classification: Once you have an inventory, each AI system needs to be meticulously assessed against the EU AI Act's risk categories (Unacceptable, High, Limited, Minimal). Pay close attention to the criteria defining high-risk systems, as these will trigger the most significant compliance obligations.
- •
Gap Analysis for High-Risk Systems: For any system identified as high-risk (or potentially high-risk), conduct a thorough gap analysis. Compare your current practices, processes, and documentation against the specific requirements outlined in the Act (as detailed in the previous section – risk management, data governance, technical documentation, etc.). Identify where your organization falls short.
- •
Implement Compliance Measures: Based on the gap analysis, develop and deploy the necessary changes. This may involve:
- •Establishing or enhancing risk management frameworks
- •Implementing new data governance protocols
- •Creating detailed technical documentation
- •Integrating logging capabilities
- •Designing user interfaces for transparency
- •Defining human oversight procedures
- •Strengthening cybersecurity measures
- •
Establish Governance Structures: Effective AI governance is crucial. Create clear internal roles, responsibilities, and accountability structures for AI development, deployment, and ongoing oversight. This might involve forming a dedicated AI ethics committee or assigning specific compliance duties to existing roles.
- •
Conduct Conformity Assessments (for High-Risk Systems): Before a high-risk AI system can be placed on the market or put into service, it must undergo a conformity assessment. This process verifies that the system meets all the relevant requirements of the Act. Depending on the specific type of high-risk AI system, this might involve self-assessment or assessment by a third-party notified body.
- •
Ongoing Monitoring and Adaptation: Compliance is not a one-time task. Implement processes for continuous monitoring of your AI systems, especially high-risk ones. Regularly review their performance, reassess risks, and update your compliance measures as needed. The AI landscape and the regulatory interpretations will evolve, so staying informed and adaptable is key.
How Arelis AI Can Help
Arelis AI's governance platform provides built-in tools to streamline EU AI Act compliance:
Core Features
- •Automated risk classification based on EU AI Act criteria
- •Pre-built templates for required documentation
- •Continuous monitoring and audit trail capabilities
- •PII detection and protection features
- •Human oversight workflow management
- •Regular updates as the regulatory landscape evolves
Benefits
By taking a proactive approach to compliance, organizations can not only avoid penalties but also build trust with customers and stakeholders by demonstrating responsible AI use.
Ready to ensure your AI systems are compliant with the EU AI Act? Contact Arelis AI today to learn how our platform can simplify your compliance journey.
Related Articles
Stay Updated
Get the latest insights on AI governance and compliance delivered to your inbox.
Subscribe to Newsletter