EU AI Act glossary · Operator roles· Art. 25

Substantial modification

A substantial modification is a change to a high-risk AI system — to its intended purpose or one affecting its compliance — that was not foreseen in the original conformity assessment, triggering a fresh assessment.

Under Article 25, an operator that substantially modifies a high-risk system, or repurposes it into a high-risk use, is treated as the provider for that system and inherits the full provider obligations.

Related terms

See how substantial modification applies to your systems

Run the free 2-minute EU AI Act checker — no sign-up.

Run the free check