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AI Regulation

AI Conformity Assessment

AI conformity assessment is the process of demonstrating that an AI system meets required legal and technical requirements before it is placed on the market or put into use.

Also known as: Conformity assessment, Compliance assessment, Pre-market assessment

Definition

Conformity assessment is a structured procedure to verify and document that a system meets specified requirements. Under the EU AI Act, high-risk AI systems typically require conformity assessment steps supported by technical documentation and testing evidence.

Why it matters

  • Market access: conformity is tied to lawful placing on the EU market for certain systems.
  • Audit readiness: assessment produces the evidence regulators and customers ask for.
  • Quality discipline: it forces clear scope, intended use, and controls.

How it works

Define scope -> implement controls -> test -> document -> assess -> maintain after changes

Assessment routes and standards vary by system category and applicable rules, so the process must be designed for the specific intended use.

Practical example

A provider prepares the technical documentation, runs validation tests, and documents risk controls for a system classified as high-risk, before releasing it to customers.

Common questions

Q: Is conformity assessment a one-time event?

A: No. Material changes, new risks, or updated standards may require reassessment and updated documentation.

Q: Who is responsible for the assessment?

A: Usually the provider, but deployers still need to ensure proper use and operational controls.

References

Regulation (EU) 2024/1689 (EU AI Act).