AION
EU AI Act-Ready AI

Regulatory Compliance

AI systems bring ethical, security, transparency, and regulatory risk. ISO 42001 helps organisations manage these risks in a structured, auditable way. We align your AI solutions with the EU AI Act and international standards: risk classification, controls, and governance from end to end.

EU AI Act

What You Get

EU AI Act

01

Correct EU AI Act risk classification

02

Transparency and explainability framework

03

Data governance and human oversight alignment

04

Provider/deployer responsibility map

05

Audit-ready compliance documentation

Compliance Gaps

What Are EU AI Act Compliance Gaps?

01

Incorrect Risk Classification and Missing Impact Assessments

Up to €35M or 7% of global turnover

Many organisations misclassify AI systems under the EU AI Act or skip mandatory impact assessments for high-risk use cases. Fines can reach €35 million or 7% of global turnover. We audit and classify your systems against international standards so you know your obligations before regulators ask.

02

Insufficient Transparency and Explainability

The EU AI Act requires users to know when they interact with AI, for example chatbots or synthetic media. Opaque model decisions erode trust and create regulatory exposure. We help you document and explain decision processes so your systems meet transparency requirements.

03

Data Governance and Human Oversight Violations

Training data must be managed responsibly, and automated decisions need effective human oversight. Gaps in data quality, bias control, or review processes create both legal and security risk. We secure data governance and integrate the oversight architecture regulators expect.

04

Neglect of Provider and Deployer Responsibilities

Indirect fines up to €15M

Roles in the AI value chain must be clear, especially when using third-party models or platforms. Missing supplier due diligence and undocumented responsibilities can trigger fines up to €15 million. We map provider and deployer obligations and align contracts and controls with ISO 42001 and the EU AI Act.

FAQ

Questions About Regulatory Compliance

Which AI systems are classified as high-risk under the EU AI Act?

High-risk AI systems include applications in employment decisions, credit scoring, law enforcement, critical infrastructure, education assessment, and certain biometric identification. Classification depends on intended purpose, deployment context, and whether the system affects fundamental rights. AION runs structured impact assessments to determine the correct category for each system.

What penalties apply for EU AI Act non-compliance?

Administrative fines vary by violation type. Prohibited AI practices can reach up to €35 million or 7% of global annual turnover. Supply-chain and provider obligations carry penalties up to €15 million or 3% of turnover. Correct risk classification, documentation, and human oversight controls reduce these exposures.

Do we need EU AI Act compliance if we only use third-party AI tools?

In most cases, yes. Deployers remain responsible for how AI systems are used, even when models or platforms come from third parties. You must verify provider documentation, run conformity assessments where required, and ensure transparency, data governance, and human oversight fit your use case.

How does AION classify our AI systems under the EU AI Act?

We audit each AI system against Annex III criteria and applicable exceptions, document intended purpose and deployment context, and map obligations to concrete controls. The output is a risk classification register, responsibility matrix, and compliance roadmap aligned with ISO 42001 and EU AI Act requirements.

Free Gap Analysis

Do not guess your audit risk before classification

In 5 minutes, map the first view of your AI risk class, control gaps, and certification roadmap.

No commitment. No sales pressure. Your data is protected under KVKK and ISO 27001 standards.

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