Article 23 of the AI Act provides valuable details related to the obligations of importers of high-risk AI systems.
Before making a high-risk AI system available on the market, the importer must ensure its conformity with the relevant provisions of the AI Act. It can do so by verifying the following:
- The relevant conformity assessment has been carried out by the provider per the requirements established in Article 43;
- The provider has drawn up and maintained the necessary technical documentation per Article 11 and Annex IV;
- The system is appropriately labeled with the CE marking and is accompanied by the EU declaration of conformity and the instructions for use; and
- The provider has appointed an authorized representative per Article 22.
If the importer has reasons to believe the high-risk AI system does not comply with the AI Act's requirements, is falsified, or is accompanied by falsified documentation, it must not place the system on the market until the same is in conformity with the necessary requirements. Additionally, if the system presents a risk as per the meaning of Article 79(1), the importer must inform the provider, the authorized representative and the market surveillance authorities.
The importer should ensure that while a high-risk AI system is under its responsibility, the storage and transportation conditions do not adversely impact the system’s legal compliance status. It must ensure the system's packaging or accompanying documentation contains its name, trade name/trademark, and contact address. The importer must maintain a copy of the certificate issued by the notified body, along with the instructions for use and the EU declaration of conformity for 10 years after introducing the high-risk AI system in the market.
It will also be responsible for cooperating with the concerned competent authorities if they make a reasoned request. The importer must provide them with all the necessary information and documentation, including technical documentation, to show that the high-risk AI system complies with the AI Act. This information must be provided in a language that is easy for the authorities to understand. The importer should cooperate with these authorities on any actions they take regarding the high-risk AI system it placed on the market, especially to help reduce or mitigate any risks the system may pose.
