Article 23: Obligations of Importers

Before placing a high-risk AI system on the Union market, the importer must verify:

1. The appropriate conformity assessment (Article 43) has been carried out 2. The provider has drawn up technical documentation per Annex IV 3. The system bears the CE marking (Article 48) 4. The system is accompanied by the EU declaration of conformity (Article 47) and instructions for use 5. The provider has appointed an authorised representative where required (Article 22)

The importer must also indicate its name, registered trade name or trademark, and contact address on the system, packaging, or accompanying documentation.

After market placement, importers must:

• Ensure storage and transport conditions do not jeopardise compliance
• Keep a copy of the conformity certificate (where Annex VII was used) and ensure documentation is available to authorities
• Inform the provider if the system presents a risk, and inform the market surveillance authority of the Member State where the system is available
• Cooperate with authorities on any corrective actions

• Article 3(6) — Definition of importer.
• Article 22 — Authorised representative the importer must verify.
• Article 24 — Distributor obligations (downstream of importer).
• Article 25 — When the importer may be re-qualified as provider.
• Article 43 — Conformity assessment the importer must verify.
• Article 47 / Article 48 — Declaration and CE marking.
• Article 18 — Documentation keeping.