Several concepts recur throughout AISDP preparation and must be understood precisely.

AI system (Article 3(1)): a machine-based system designed to operate with varying levels of autonomy, that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers from input how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments. Provider : the entity that develops an AI system or has one developed and places it on the market or puts it into service under its own name or trademark. Deployer : the entity that uses the system under its authority. Many organisations hold both roles simultaneously, which triggers dual obligations.

Intended purpose : the use for which the provider intends the system, as specified in the instructions for use, technical documentation, and Declaration of Conformity. Substantial modification : a change after placing on the market that was not foreseen or planned by the provider and that affects compliance or modifies the intended purpose; provide quantitative thresholds for identifying these. Placing on the market : the first making available on the Union market, which starts the ten-year documentation retention clock.

The AISDP itself is structured as twelve modules, each traceable to source evidence: System Identity, Development Process, Architecture and Design, Data Governance, Testing and Validation, Risk Management System, Human Oversight, Transparency and User Information, Robustness and Cybersecurity, Record-Keeping, FRIA, and Post-Market Monitoring and Change History. Every claim in the AISDP requires a supporting artefact. The approach described across these articles generates that evidence as a natural byproduct of the engineering workflow.

Key outputs

None (contextual article)