AI Act Documents:

Article 33: Subsidiaries of Notified Bodies and Subcontracting

Comes into force 2 August 2025, according to Article 113(b)
1. Where a notified bodynotified bodymeans a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislationArticle 3(22) subcontracts specific tasks connected with the conformity assessmentconformity assessmentmeans the process of demonstrating whether the requirements set out in Chapter III, Section 2 relating to a high-risk AI systemAI systemmeans a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environmentsArticle 3(1) have been fulfilledArticle 3(20) or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements laid down in Article 31, and shall inform the notifying authoritynotifying authoritymeans the national authority responsible for setting up and carrying out the necessary procedures for the assessment, designation and notification of conformity assessment bodies and for their monitoringArticle 3(19) accordingly.
2. Notified bodies shall take full responsibility for the tasks performed by any subcontractors or subsidiaries.
3. Activities may be subcontracted or carried out by a subsidiary only with the agreement of the providerprovidermeans a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of chargeArticle 3(3). Notified bodies shall make a list of their subsidiaries publicly available.
4. The relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary and the work carried out by them under this Regulation shall be kept at the disposal of the notifying authoritynotifying authoritymeans the national authority responsible for setting up and carrying out the necessary procedures for the assessment, designation and notification of conformity assessment bodies and for their monitoringArticle 3(19) for a period of five years from the termination date of the subcontracting.