Chapter III · Section 5 · Standards, conformity assessment, certificates, registration
Article 47 — EU declaration of conformity
▼ Primary text, verbatim. Our annotations appear below, visibly separated.
1. The provider shall draw up a written machine readable, physical or electronically signed EU declaration of conformity for each high-risk AI system, and keep it at the disposal of the national competent authorities for 10 years after the high-risk AI system has been placed on the market or put into service. The EU declaration of conformity shall identify the high-risk AI system for which it has been drawn up. A copy of the EU declaration of conformity shall be submitted to the relevant national competent authorities upon request.
2. The EU declaration of conformity shall state that the high-risk AI system concerned meets the requirements set out in Section 2. The EU declaration of conformity shall contain the information set out in Annex V, and shall be translated into a language that can be easily understood by the national competent authorities of the Member States in which the high-risk AI system is placed on the market or made available.
3. Where high-risk AI systems are subject to other Union harmonisation legislation which also requires an EU declaration of conformity, a single EU declaration of conformity shall be drawn up in respect of all Union law applicable to the high-risk AI system. The declaration shall contain all the information required to identify the Union harmonisation legislation to which the declaration relates.
4. By drawing up the EU declaration of conformity, the provider shall assume responsibility for compliance with the requirements set out in Section 2. The provider shall keep the EU declaration of conformity up-to-date as appropriate.
5. The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend Annex V by updating the content of the EU declaration of conformity set out in that Annex, in order to introduce elements that become necessary in light of technical progress.
This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex.
What this means for you
In your terms · EU declaration of conformity and CE marking
Digital systems carry a digital CE marking; it is part of the shipping surface.
In your terms · EU declaration of conformity and CE marking
The declaration is the formal claim that everything upstream (risk management, data, documentation, assessment) holds; signing it is the accountability moment.
- EU declaration of conformity per system
Failure smells likeThe system is on the market with no signed declaration behind it, because drawing one up was treated as paperwork that follows the release.
Obligations derived from this article
If you would rather not read the law
The basics page explains the Regulation's own categories in order: scope, role, tier, date. The engineering view groups the obligations by the platform capability they demand.