Glossary term
Glossary term
Governance and Compliance
A change to an AI system that affects its intended purpose, risk profile, compliance status, or conformity with applicable requirements. It can trigger renewed assessment, updated documentation, fresh approvals, or a change in regulatory responsibility. Change governance must define what counts as substantial before teams change model versions, intended use, user groups, prompts, tools, or data sources.
EU AI Act Article 3(23) defines substantial modification as a change not foreseen by the provider that affects compliance with high-risk requirements or modifies intended purpose.
A deployer that substantially fine-tunes a foundation model and rebrands it can become a provider under EU AI Act Article 25, inheriting heavier obligations.
FDA's Predetermined Change Control Plans framework distinguishes pre-authorized modifications from those requiring fresh 510(k) review.