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EnforcementHigh-risk July 8, 2026

The notified-body bottleneck: capacity for high-risk assessment is thin

The AI conformity-assessment ecosystem is still being built, echoing the MDR and IVDR experience.

ANALYSIS — EDITORIAL, NOT THE LEGAL RECORD

The register of notified bodies for AI Act conformity assessment is still filling out through NANDO, and capacity is a known constraint. The parallel most often drawn is medical devices, where a shortage of designated bodies became a lasting bottleneck.

The exposure is narrower than it first appears. Most high-risk systems use internal self-assessment under Annex VI. A notified body is required mainly for remote biometric identification and for AI embedded in Annex I products that already need third-party assessment.

That still leaves a real question for the systems that do need a body: whether enough AI-designated organisations exist by the time high-risk obligations bite in December 2027 and August 2028. The deferral bought time to build the capacity — if it is used.

Sources: Art. 35 · Annex VI · verified 2026-07-16
Analysis is original writing by the euaicompliant desk. Not legal advice — the binding text is on EUR-Lex.
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