EU AI Act Assessment

An EU AI Act Assessment is a comprehensive evaluation that determines whether your AI systems comply with the European Union’s Artificial Intelligence Act, otherwise known as the EU AI Act.The EU AI Act came into force on August 1, 2024.

This assessment identifies your AI systems, classifies them by risk level, and ensures they meet all regulatory requirements. You need one because the EU AI Act applies to any organization using AI systems in the EU market, with penalties reaching up to €35 million or 7% of global annual turnover for non-compliance.

The EU AI Act uses a risk-based approach, categorizing AI systems into four levels:

• Unacceptable risk (banned),
• High-risk (strict requirements),
• Limited risk (transparency obligations),
• Minimal/no risk (largely unregulated).

Understanding your system’s classification is crucial for determining your compliance obligations.

High-risk AI systems must meet several stringent requirements including:

• Establishing a risk management system throughout the system’s lifecycle,
• Implementing data governance programs to ensure training data quality,
• Maintaining comprehensive technical documentation,
• Designing automatic logging capabilities,
• Providing clear instructions for deployers,
• Enabling human oversight,
• Achieving appropriate accuracy and cybersecurity levels,
• Establishing a quality management system.

Additionally, providers must register their systems in the EU database and conduct conformity assessments before market placement.

The EU AI Act has staggered implementation dates:

• Prohibited AI systems (unacceptable risk) have been banned since February 1, 2025,
• General-purpose AI regulations apply from August 1, 2025,
• Most other provisions take effect August 1, 2026,
• High-risk systems already subject to other EU regulations have until August 1, 2027.

Organizations should begin compliance preparation immediately, as the assessment and implementation process can be complex and time-consuming.

Yes, the EU AI Act has extraterritorial reach.

If your organization places AI systems on the EU market, puts them into service in the EU, or if the output of your AI systems is intended for use in the EU, you’re subject to the Act regardless of your location.

Non-EU providers of high-risk AI systems must appoint an authorized representative in the EU. This is similar to how GDPR applies to organizations outside the EU that process EU residents’ data.

A provider develops, manufactures, or substantially modifies an AI system and places it on the market or puts it into service under their own name or trademark.

A deployer uses an AI system under their authority for their intended purpose.

Providers face more extensive obligations including conformity assessments, CE marking, and EU database registration.

Deployers must follow instructions for use, ensure human oversight, and may need to conduct fundamental rights impact assessments for certain high-risk systems

EU AI Act penalties are tiered based on violation severity:

Using prohibited AI practices can result in fines up to €35 million or 7% of worldwide annual turnover (whichever is higher),

Violating data governance or transparency requirements can lead to fines up to €7.5 million or 1% of worldwide turnover,

Other violations can result in fines up to €15 million or 3% of worldwide turnover. These substantial penalties make compliance assessment and implementation a critical business priority.

EU AI Act compliance requires extensive technical documentation including:

• System specifications and capabilities,
• Development methodology and techniques,
• Risk assessment and management procedures,
• Data governance measures,
• Human oversight provisions,
• Accuracy and robustness testing results,
• Cybersecurity measures,
• Quality management system documentation,
• Post-market monitoring plans.

This documentation must be maintained throughout the AI system’s lifecycle and made available to authorities upon request.

A comprehensive EU AI Act Assessment typically involves several phases:

1. AI system inventory and identification,
2. Risk classification according to EU AI Act categories,
3. Gap analysis against applicable requirements,
4. Compliance roadmap development,
5. Implementation guidance.

The timeline varies based on your organization’s size, number of AI systems, and their complexity. Most assessments take 4-8 weeks for initial evaluation, with implementation timelines varying based on identified gaps and required remediation measures.

Yes, the EU AI Act includes specific provisions to support SMEs and startups.

These measures include:

• Priority access to regulatory sandboxes,
• Tailored awareness-raising activities,
• Dedicated communication channels for guidance,
• Reduced conformity assessment fees based on company size and development stage,
• Encouragement to participate in standards development processes.

However, compliance obligations remain the same regardless of company size, making professional assessment services valuable for resource-constrained organizations.