Art. 47

Article 47: EU Declaration of Conformity

Article 47 requires providers to draw up a written, signed EU declaration of conformity for each high-risk system, stating that the requirements of Articles 8 to 15 have been met, and to keep it available to national authorities for ten years after the system is placed on the market. This declaration is the legal basis underlying the CE marking affixed under Article 48.

provider high-risk
When it applies
What it requires
What you keep on file
Commonly misread

The EU declaration of conformity is often conflated with the CE mark itself; the declaration is the underlying legal statement of compliance, while the CE mark under Article 48 is the physical or digital symbol affixed once the declaration exists.

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Informational content only. Not legal advice and not a substitute for qualified counsel. Dates reflect Regulation (EU) 2026/1744 as of 04 Aug 2026.