Article 47 of the AI Act provides information related to the EU's declaration of conformity.
The provider must create and provide a machine-readable, physical, or electronically signed EU declaration of conformity for each high-risk AI system and ensure such records are maintained at the disposal of the national competent authorities for 10 years after such systems are placed on the market or put into service. The declaration of conformity must identify the system it has been drawn up for.
The declaration must categorically state that the high-risk AI system meets the requirements of Section 2 of the AI Act (risk management system, technical documentation, data governance, record-keeping, transparency, human oversight, accuracy, robustness, and cybersecurity). Further, it must contain the information required per Annex V. It should also be translated into a language that can be easily understood by the national competent authority of the EU member states where the high-risk AI system is made available or put into service.
In cases where the high-risk AI system is subject to other EU harmonization legislation that also requires an EU declaration of conformity, a single such declaration must be drawn up that appropriately addresses all the EU laws that may apply to that system. The declaration must contain all the information required to identify the applicable EU laws. By drawing up such a declaration of conformity, the provider assumes responsibility for compliance with the requirements of Section 2 of the Act. It must also ensure that this declaration is kept updated at all times.
The European Commission may adopt delegated acts to update the required contents for the declaration of conformity (per Annex V) and introduce new elements owing to technical progress.
