Super Intelligence definition proposal due (60 days) · Nov 28, 2026 · See what changes
A third-party conformity assessment organization designated by an EU member state to assess AI systems against the EU AI Act before they are placed on the market as high-risk AI. Notified bodies review technical documentation, assess quality management systems, and issue certificates. Most Annex III high-risk systems use internal control instead. A notified body is involved for biometric systems in point 1 of Annex III unless the provider applied harmonised standards, and for AI in products under Annex I (such as medical devices) where that product's own law requires third-party assessment.
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.