AI Ethics & EU AI Act Compliance Software

Enforcement of the EU AI Act (Regulation 2024/1689) is arriving in phases: prohibited AI practices from February 2025, general-purpose AI rules by mid-2025, and full high-risk system obligations by August 2026. Any organisation that develops, deploys, or distributes AI systems within the European Union must classify each system by risk tier — unacceptable, high, limited, or minimal — and compile conformity documentation proportional to that classification. Penalties reach 7% of worldwide annual turnover for violations involving prohibited practices, the highest fine ceiling in EU regulatory history.

High-risk AI systems face the heaviest burden: technical files demonstrating data governance, accuracy metrics, robustness testing, cybersecurity controls, and human oversight protocols must exist before market placement and stay current throughout the system lifecycle. For companies in the electronics and IoT sector, the AI Act intersects with the Cyber Resilience Act, creating overlapping but distinct obligations for connected products that incorporate machine learning.

Sustalium structures this process around the Act's risk tiers. Each AI system in your inventory receives its own compliance record containing the mandated fields — intended purpose, training data provenance, bias evaluation results, transparency notices, and human oversight procedures. Evidence is linked at the system level, so teams managing multiple AI products maintain separate, auditable dossiers without duplicating shared governance policies. When national authorities request documentation, you export a complete conformity package rather than assembling it under deadline pressure.