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EU AI Act Article 43: which conformity assessment route applies

Article 43 sets out how a high-risk AI system is assessed before it can be placed on the market. For most Annex III systems, the provider can follow the internal control procedure in Annex VI. Where the system is a remote biometric identification system, a different route applies, generally involving a notified body under Annex VII, unless harmonised standards or common specifications have been applied in full. AI systems that are safety components of products already covered by EU sectoral legislation (Annex I) follow the conformity assessment procedure of that legislation instead. A substantial modification, per Article 25, triggers a new conformity assessment.

Who it applies to

Providers of high-risk AI systems before they place the system on the market or put it into service, and again whenever a change to the system or its purpose is substantial enough to affect compliance.

What evidence this implies

Whichever route applies, the assessment relies on the technical documentation described in Annex IV and on the quality management system of Article 17. For internal control, the provider itself checks the system against the requirements and records the outcome; for notified-body assessment, that body needs the same underlying evidence, plus test and evaluation results, in a form it can review.

Gaps to state honestly

Conformity assessment is a point-in-time judgment against the Chapter III Section 2 requirements. It does not certify that every future run of the system will behave the same way — that is what ongoing logging and post-market monitoring under Article 72 are for. A ledger cannot substitute for the assessment itself.

How Vetro helps

Vetro does not perform conformity assessment. What it provides is the runtime evidence — a hash-chained, ed25519-signed ledger of model calls, tool calls, and policy decisions — that a technical documentation file or a notified body can cite as proof the system behaves as documented after deployment. Vetro Attest verifies a ledger or OTLP GenAI trace for free and, for 49 USD, issues a counter-signed report mapping that evidence to the EU AI Act. This is technical evidence, not legal advice.

Check whether your system needs Annex III assessment at all with the high-risk classifier, or start a free verification at Vetro Attest.

See a sample ledger verified in one click, check your own logs free or get the countersigned EU AI Act report.