Importer Compliance Gate

The importer must verify that the foreign manufacturer has performed the appropriate conformity assessment procedure. This involves checking that the technical documentation demonstrates compliance with the essential requirements of the EU AI Act. The importer is not merely accepting a declaration at face value but must confirm the existence of a valid Declaration of Conformity and, where applicable, a CE marking.

• Confirm the correct assessment module was applied (internal control vs. notified body).
• Verify the quality management system is certified if required by Annex VI.
• Ensure the assessment covers the system's intended purpose as it will be marketed in the Union.

The importer must ensure the provider (manufacturer) has registered the high-risk AI system in the EU AI Act Database before placing it on the market. The importer should obtain the Unique Registration ID and verify its validity. This step prevents unregistered, non-compliant systems from entering the Union supply chain.

• Cross-reference the Unique Registration ID with the public EU database.
• Confirm the registration details match the system's intended purpose declaration.
• Retain evidence of this verification as part of the importer's own compliance file.

If the non-EU manufacturer has not designated an authorized representative established within the Union, the importer must fulfill this role by default. This means the importer assumes legal responsibility for holding the technical documentation file, the Declaration of Conformity, and acting as the primary point of contact for National Competent Authorities.

• Maintain a complete copy of the technical documentation for 10 years.
• Cooperate with authorities on any corrective actions or market withdrawal notifications.
• Ensure the importer's name, registered trade name, and address are on the system or its packaging.

The importer must ensure the system is linked to a post-market monitoring plan. While the provider typically operates the plan, the importer is obligated to verify its existence and report any serious incidents or substantial modifications they become aware of. The importer acts as a critical sensor in the incident reporting linkage chain.

• Verify the provider has a systematic plan for collecting real-world performance data.
• Immediately inform the provider and market surveillance authority of any serious incident.
• Do not place a system on the market if it has been substantially modified without a new conformity assessment.

The importer must ensure that storage and transport conditions do not jeopardize the system's compliance with the essential requirements. This is a specific obligation under Article 27 of the EU AI Act. If a model's performance or safety features degrade due to improper environmental conditions during warehousing or shipping, the importer is liable.

• Adhere to manufacturer-specified environmental parameters (temperature, humidity, shock).
• Implement supply chain controls to prevent tampering or data poisoning during transit.
• Document all storage and logistics conditions for the audit trail.

The importer must verify that the system bears the CE marking and is accompanied by the required instructions and transparency information in a language easily understood by end-users, as determined by the member state. This includes the residual risk disclosure and any operational constraints.

• Check for the physical or digital CE marking on the system or packaging.
• Ensure the intended purpose declaration is clear and not misleading.
• Translate user instructions and safety information into the official languages of the target market.