How does the AI Act affect product compliance?

Dutch term: AI Act | Legal basis: Regulation (EU) 2024/1689

The EU AI Act (Regulation (EU) 2024/1689) establishes a risk-based regulatory framework for artificial intelligence systems placed on the EU market. High-risk AI systems, including AI embedded in regulated products (machinery, medical devices, vehicles), must undergo conformity assessment, maintain technical documentation, and comply with requirements on data governance, transparency, human oversight and robustness.

For products that already require CE marking under sector-specific legislation, the AI Act adds an additional compliance layer: the AI-specific requirements must be assessed alongside the existing essential requirements of the applicable product directive or regulation. Notified bodies involved in conformity assessment of the product must also assess the AI component.

Why it matters for international businesses

Manufacturers integrating AI into physical products need to coordinate their AI Act compliance with existing CE marking and product safety obligations, creating a complex but navigable compliance picture.