AI for Technology & SaaS

Before placing a high-risk AI system on the EU market, providers must complete a conformity assessment — either self-assessment or third-party assessment by a notified body, depending on the use case. This is not optional.

High-risk AI systems must bear the CE marking to indicate conformity with the EU AI Act. This requires a declaration of conformity, technical documentation, and an active quality management system.

Comprehensive technical documentation covering system design, development methodology, training data, performance metrics, risk management, and testing results. This documentation must be maintained throughout the system's lifecycle.

Providers must establish a post-market monitoring system proportionate to the nature and risk of the AI system. This includes collecting performance data, tracking incidents, and updating documentation when issues emerge.

Non-EU providers must appoint an EU-based authorised representative before placing AI systems on the market. The representative acts as the compliance contact for market surveillance authorities.

Providers must report serious incidents — including malfunctions that pose risks to health, safety, or fundamental rights — to market surveillance authorities. Reporting obligations begin immediately upon awareness.