Conformity Assessment
The procedure demonstrating that a high-risk AI system meets the Act's requirements before it goes on the market.
Conformity assessment is the compliance gate for high-risk systems, done either by the provider itself or through a notified body depending on the use case. It ends in a declaration of conformity, CE marking, and registration in the EU database. Substantial modification can require repeating it.
In practice: A documented file showing the risk management, data governance, and testing behind the system.
Plain-English summary. The binding text is Regulation (EU) 2024/1689.