The EU AI Act (Regulation (EU) 2024/1689) is the first comprehensive regulatory framework governing artificial intelligence systems at scale. It becomes fully enforceable for high-risk systems on 2 August 2026, requiring every high-risk AI system placed on the Union market to carry a completed conformity assessment, a signed Declaration of Conformity, CE marking where applicable, and a registration entry in the EU database.
AI systems present a distinctive regulatory challenge because of their relationship with time. A traditional application behaves tomorrow the way it behaves today unless someone deliberately changes it. An AI system, by contrast, is designed to improve through learning, and that learning introduces continuous change that conventional software governance was never built to handle. Models are retrained on new data; feature distributions shift as the population served by the system evolves; fine-tuning adjusts behaviour in ways that may be subtle and difficult to document after the fact.
The evidentiary backbone for meeting the Act’s requirements is a single artefact: the AI System Documentation Package (AISDP). A national competent authority will open the AISDP first during any inquiry. A notified body will scrutinise it for technical rigour. Internal governance, legal counsel, and engineering teams will consult it throughout the system’s operational life, and it must remain retrievable for ten years after the system is placed on the market.
The Act tells organisations what they must document. It does not tell them how. Articles 8 through 15 set out the substantive requirements; Annex IV specifies the technical documentation contents. The gap between a regulatory requirement and the engineering workflow that satisfies it is where most compliance programmes stall. The AISDP preparation process described in these articles occupies that gap, translating every material obligation into concrete engineering practices, governance processes, and organisational structures.
Key outputs
None (contextual article)