Examples
Worked examples
- Is an instance
A CE-marked AI-based medical-device manufacturer compiling the technical file for AI Act conformity.
- Is an instance
A high-risk recruitment-AI provider engaging a notified body for conformity assessment.
Counter-examples
Looks similar, but isn't
- Not an instance
An informal internal review without documentation.
- Not an instance
A research-only model never placed on a market.
Editorial commentary
An AI conformance assessment (conformity assessment) is a formal evaluation, conducted by the AI system provider or a notified third-party body, demonstrating that an AI system meets the applicable regulatory or standards-based requirements before it is placed on the market.
Where it applies under the EU AI Act
Under the EU AI Act, high-risk AI systems (the Annex III use-case categories and Annex I product-safety-component systems) must undergo conformity assessment before market placement and before receiving CE marking. For most Annex III categories, the provider may self-assess conformity against the Act’s requirements; for the narrower set of categories the Act designates for independent scrutiny, a notified third-party body must carry out the assessment instead. The harmonised technical standards that conformity assessments will be measured against are still being developed by CEN-CENELEC Joint Technical Committee 21 (JTC 21), which is why exact conformity-assessment procedures for specific high-risk categories remain a moving target as of this writing.
How this differs from an evaluation card or a management-system certification
A conformance assessment is a pass/fail regulatory determination tied to a specific legal requirement and a specific market — it is not the same thing as an AI evaluation card, which documents a benchmark evaluation’s methodology and results without asserting regulatory compliance, and it is not the same thing as ISO/IEC 42001 certification, which certifies an organisation’s overall AI governance processes rather than a single product’s compliance with a specific law. A provider could hold ISO/IEC 42001 certification and still need a separate, product-specific EU AI Act conformity assessment for a given high-risk system.
Sources
Regulation (EU) 2024/1689, Articles 43 and 48; CEN-CENELEC JTC 21 work programme.
Also known as
AI conformity assessment · AI CA
Machine-readable encodings
Use in your systems
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