EU AI Act: A Risk-Based Approach to Managing AI Compliance
1. Objective and Scope
The EU AI Act aims to ensure that AI systems placed on the EU market are safe, respect fundamental rights, and encourage trustworthy innovation. It applies to both public and private actors who provide or use AI in the EU, regardless of whether they are based in the EU or not. The Act follows a risk-based approach, categorizing AI systems into four levels of risk: unacceptable, high, limited, and minimal.
2. Prohibited AI Practices
Certain AI applications are completely banned because they violate fundamental rights. These include systems that manipulate human behavior, exploit vulnerabilities of specific groups, enable social scoring by governments, or use real-time remote biometric identification in public spaces (with narrow exceptions such as law enforcement).
3. High-Risk AI Systems
AI systems used in critical sectors—like biometric identification, infrastructure, education, employment, access to public services, and law enforcement—are considered high-risk. These systems must undergo strict compliance procedures, including risk assessments, data governance checks, documentation, human oversight, and post-market monitoring.
4. Obligations for High-Risk AI Providers
Providers of high-risk AI must implement and document a quality management system, ensure datasets are relevant and free from bias, establish transparency and traceability mechanisms, and maintain detailed technical documentation. They must also register their AI system in a publicly accessible EU database before placing it on the market.
5. Roles and Responsibilities
The Act defines clear responsibilities for all actors in the AI supply chain—providers, importers, distributors, and deployers. Each has specific obligations based on their role. For instance, deployers of high-risk AI systems must ensure proper human oversight and inform individuals impacted by the system.
6. Limited and Minimal Risk AI
For AI systems with limited risk (like chatbots), providers must meet transparency requirements, such as informing users that they are interacting with AI. Minimal-risk systems (e.g., spam filters or AI in video games) are largely unregulated, though developers are encouraged to voluntarily follow codes of conduct and ethical guidelines.
7. General Purpose AI Models
General-purpose AI (GPAI) models, including foundation models like GPT, are subject to specific transparency obligations. Developers must provide technical documentation, summaries of training data, and usage instructions. Advanced GPAIs with systemic risks face additional requirements, including risk management and cybersecurity obligations.
8. Enforcement, Governance, and Sanctions
Each Member State will designate a national supervisory authority, while the EU will establish a European AI Office to oversee coordination and enforcement. Non-compliance can result in fines of up to €35 million or 7% of annual global turnover, depending on the severity of the violation.
9. Timeline and Compliance Strategy
The AI Act will come into effect in stages after formal adoption. Prohibited practices will be banned within six months; GPAI rules will apply after 12 months; and the core high-risk system obligations will become enforceable in 24 months. Businesses should begin gap assessments, build internal governance structures, and prepare for conformity assessments to ensure timely compliance.
EU publishes General-Purpose AI Code of Practice: Compliance Obligations Begin August 2025
For U.S. organizations operating in or targeting the EU market, preparation involves mapping AI use cases against the Act’s risk tiers, enhancing risk management practices, and implementing robust documentation and accountability frameworks. By aligning with the EU AI Act’s principles, U.S. firms can not only ensure compliance but also demonstrate leadership in trustworthy AI on a global scale.
A compliance readiness checklist for U.S. organizations preparing for the EU AI Act:
👉 EU AI Act Compliance Checklist for U.S. Organizations
The EU Artificial Intelligence (AI) Act: A Commentary
What are the benefits of AI certification Like AICP by EXIN
The New Role of the Chief Artificial Intelligence Risk Officer (CAIRO)
InfoSec services | InfoSec books | Follow our blog | DISC llc is listed on The vCISO Directory | ISO 27k Chat bot | Comprehensive vCISO Services | ISMS Services | Security Risk Assessment Services
