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A third-party conformity assessment organization accredited by an EU member state to audit, test, and certify AI systems before they may be placed on the EU market as high-risk AI. Notified bodies review technical documentation, conduct audits, test system performance, and issue EU type-examination certificates confirming that a system meets the EU AI Act's requirements. Not all high-risk AI systems require third-party notified body assessment — some allow self-declaration of conformity — but those in regulated sectors (medical devices, critical infrastructure, biometrics) typically do.
Why this matters for your team
If your AI system requires notified body certification, plan for it 12–18 months before your EU launch target. There are a limited number of accredited bodies, assessment timelines are long, and costs run into the tens of thousands of euros. Factor this into product roadmaps and funding rounds.
A medical device company embedding AI-based diagnostics into its product must engage an EU notified body to audit its technical documentation and test the AI component before applying CE marking and launching in the EU.