Article 43: Conformity assessment

Article 43 describes two routes: internal control based on Annex VI, or assessment by a notified body based on Annex VII, depending on the type of AI system.

Third-party assessment is mandatory for biometric AI systems (point 1 of Annex III) where the provider has not applied harmonised standards or common specifications.

Article 43 of the AI Act does not provide a general exemption for SMEs. However, the AI Act includes supportive measures and potentially lighter obligations for small and medium-sized enterprises, depending on their role in the AI value chain.

Article 43 of the AI Act complements the GDPR. While the GDPR protects personal data, the AI Act focuses on the safety and trustworthiness of AI systems. Organisations must comply with both regulations when their AI system processes personal data.

The AI Act follows a phased implementation. Prohibited AI practices apply from February 2025, obligations for high-risk AI systems from August 2026, and other provisions take effect gradually. The specific deadline for Article 43 depends on the category of the obligation.

Yes, Article 43 of the AI Act may also be relevant when you purchase AI systems. As a deployer, you have your own obligations under the AI Act, regardless of whether you developed the system yourself or purchased it from a provider.

Under Article 43 of the AI Act, the provider is the entity that develops or places the AI system on the market, while the deployer is the entity that uses the system under its own authority. Both roles carry different obligations.

Article 43 of the AI Act requires that relevant documentation is maintained as part of the compliance process. This may include technical documentation, instructions for use, logs or declarations of conformity, depending on the classification of the AI system.