AI governance glossary
Substantial modification
Definition
A change to an AI system after it is placed on the market that the provider's original conformity assessment did not foresee, and that affects its compliance or changes its intended purpose. Under the EU AI Act, whoever makes a substantial modification to a high-risk system can become its provider, with the provider's duties.
Source: EU AI Act (Regulation (EU) 2024/1689). A plain-language explanation for orientation, not the legal text; follow the source for the binding wording.
Release and change management control →
Laws and policies on record that use it
- EU AI ActEuropean Union · Partially applicable
- Colorado AI ActColorado (United States) · Repealed
Duties that mention it
- Deployers, distributors and importers must assume provider duties when they rebrand or substantially modify high-risk AIEU AI Act · European Union
- Deployers must complete impact assessments for high-risk AIColorado AI Act · Colorado (United States)
Related terms
- AI systemA machine-based system that operates with some autonomy, may adapt after it is deployed, and infers from the i...
- Intended purposeThe use a provider intends an AI system for, including the context and conditions of use, as stated in its ins...
- Conformity assessmentThe process of showing that a high-risk AI system meets the EU AI Act's requirements before it is placed on th...
- Red teaming (AI)Structured adversarial testing in which testers try to make an AI system fail: produce harmful output, leak da...
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Frequently asked questions
What does "Substantial modification" mean?
A change to an AI system after it is placed on the market that the provider's original conformity assessment did not foresee, and that affects its compliance or changes its intended purpose. Under the EU AI Act, whoever makes a substantial modification to a high-risk system can become its provider, with the provider's duties.
Where does the term Substantial modification come from?
This explanation follows EU AI Act (Regulation (EU) 2024/1689). It is a plain-language paraphrase for orientation; the source has the binding wording.
Which laws and policies use the term Substantial modification?
Among the records on this site: EU AI Act (EU) and Colorado AI Act (Colorado).