A notified body is an independent organisation designated by an EU member state to assess the conformity of certain products, including specified high-risk AI systems, with the applicable requirements of EU law before they are placed on the market.
In practiceUnder the EU AI Act, third-party conformity assessment by a notified body is required for a defined subset of high-risk systems, primarily those that are safety components of products already covered by EU harmonisation legislation, and for certain biometric use cases. Most high-risk AI providers rely on internal conformity assessment instead, supported by the Annex IV technical documentation. A common confusion is to assume that all high-risk systems need a notified body: in practice, the route to conformity depends on the category and the legislative framework that already applies.
A manufacturer placing an AI-driven safety component for industrial machinery on the EU market engages a notified body to assess the AI system together with the machinery, since the product already falls under the machinery legislation in Annex I.
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