The EU AI Act Compliance Guide

Risk Classification Framework

The EU AI Act applies regulatory burdens proportionally based on the inherent risk of the deployed artificial intelligence system.

Prohibited Systems

High-Risk AI

General Purpose AI

Cognitive behavioral manipulation, untargeted scraping of facial images, and social scoring systems are strictly banned under the regulation.

Systems in healthcare, critical infrastructure, and biometrics must comply with strict QMS, logging, and human oversight obligations.

GPAI models require technical documentation, adversarial testing, and systemic risk evaluations under the tiered compliance framework.

The Compliance Roadmap

Classify Your System

Establish a QMS

Compile Technical Docs

Conformity Assessment

Determine if your AI application falls under prohibited, high-risk, or general-purpose categories based on intended use.

Implement a quality management system aligned with ISO/IEC 42001 to govern data, testing, and lifecycle risk.

Draft Annex IV technical documentation detailing model architecture, training datasets, and validation metrics.

Complete internal control checks or third-party audits before placing the high-risk system on the European market.

Regulatory FAQ

Clear answers to critical compliance questions regarding timelines, enforcement, and international standards integration.

When does enforcement begin?

Who is classified as a provider?

Prohibitions take effect 6 months post-entry into force. High-risk obligations apply within 24 to 36 months, depending on the specific system classification.

Any entity that develops an AI system or has an AI system developed with a view to placing it on the market under its own name.

Does ISO 42001 satisfy the Act?

What are the penalty risks?

ISO/IEC 42001 provides a structured management system that heavily overlaps with the Act's Quality Management System requirements, serving as an excellent foundation.

Non-compliance with prohibited practices can result in administrative fines of up to 35 million EUR or 7% of global annual turnover.

Prepare Your Compliance Framework

Download our structured compliance checklists, risk registers, and technical documentation templates designed for rigorous regulatory alignment.