GovernanceCore
Regulation

Conformity assessment

Working definition

Reviewed 30 July 2026

Conformity assessment is the process used to verify and document that a product or system satisfies specified requirements. Under the EU AI Act, providers of high-risk AI systems must complete the applicable conformity assessment before placing the system on the market or putting it into service.

Context

Why it matters

The route, evidence, and involvement of a third party vary by system type and applicable product law. Misclassification can delay launch or leave a provider without required assurance.

Operating note

What this looks like in practice

  1. 01Confirm the applicable legal route and whether a notified body is required.
  2. 02Align technical documentation, quality management, testing, and risk records.
  3. 03Repeat assessment when a change qualifies as substantial modification.

Sources & further research

Primary authority anchors the definition. Research links add conceptual or operational depth. External sources may update independently; always verify legal duties against the current official text.

  1. Official source

    Regulation (EU) 2024/1689, Articles 43–49

    Sets conformity-assessment routes and associated registration and declaration requirements.

    European Union
    2024    Open source ↗
  2. Official source

    The Blue Guide on the implementation of EU product rules 2022

    Explains conformity assessment within the wider EU product-compliance system.

    European Commission
    2022    Open source ↗