What Is Conformity Assessment?
Conformity Assessment is the process by which a provider of an AI system demonstrates that it meets the requirements of an applicable regulation or standard before placing the system on the market.
Conformity Assessment, the process by which a provider of an AI system demonstrates that it meets the requirements of an applicable regulation or standard before placing the system on the market.
Under the EU AI Act, high-risk AI must undergo a conformity assessment before deployment. For most high-risk AI, this is self-assessment against the Act's requirements. For AI embedded in certain regulated products (medical devices, machinery), third-party conformity assessment by a notified body is required. The outcome is CE marking. Conformity assessments must be documented in technical files that regulators can request.
Source: EU AI Act, Articles 43–44
Plain-language explanation
Under the EU AI Act, high-risk AI must undergo a conformity assessment before deployment. For most high-risk AI, this is self-assessment against the Act's requirements. For AI embedded in certain regulated products (medical devices, machinery), third-party conformity assessment by a notified body is required. The outcome is CE marking. Conformity assessments must be documented in technical files that regulators can request.
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