Art.47

Article 47 — EU Declaration of Conformity

High-Risk Systems SME Relevant ~3 min read · 535 words

Article 47 requires every provider of a high-risk AI system to draw up an EU declaration of conformity before placing their system on the market. This is the provider’s formal written statement — signed under their own responsibility — that their AI system meets all applicable requirements of the EU AI Act. It is one of the most tangible compliance deliverables the Act requires.

! High compliance impact for SMEs

WHAT THE ARTICLE IS ABOUT

The provider’s formal written declaration that their AI system is compliant

Article 47 establishes the EU declaration of conformity — the document in which a provider formally declares, under their sole responsibility, that their high-risk AI system complies with the EU AI Act. It is a legally significant document that must accompany every high-risk AI system placed on the EU market, and its content is specified in Annex V of the Act.

WHAT IT SAYS

One declaration per system, updated when necessary, kept for ten years

Providers must draw up an EU declaration of conformity for each high-risk AI system and keep it up to date
The declaration must contain all the information specified in Annex V — including the provider’s identity, a description of the AI system, a statement that the system conforms to the Act, references to harmonised standards or common specifications applied, where applicable the identification number of the notified body and certificate reference, the place and date of issue, and the provider’s signature
Where multiple EU legislative acts require a declaration of conformity, a single declaration may be drawn up covering all applicable acts — reducing duplication
The declaration must be available to national competent authorities on request
The provider must keep the declaration for ten years after the system is placed on the market — matching the technical documentation retention period under Article 18
By drawing up the declaration, the provider assumes full responsibility for the system’s compliance

WHO IS AFFECTED

All providers of high-risk AI systems

All providers of high-risk AI systems — the declaration is mandatory before market placement
Authorised representatives of non-EU providers who may draw up the declaration on the provider’s behalf
Importers who must verify the declaration exists and is accurate before placing systems on the market
Distributors who must verify the declaration accompanies the system
Market surveillance authorities who may request the declaration during investigations

WHAT IT MEANS FOR SMES

A formal document you draft yourself — but must be accurate

The EU declaration of conformity is not issued by a notifying body or authority — you write it yourself and sign it under your own responsibility
This means the declaration is only as credible as the compliance work behind it — a declaration drawn up without completing the full conformity assessment process is legally worthless and creates liability
Use Annex V as your template — it specifies exactly what the declaration must contain, making this a structured drafting task rather than an open-ended document
Where your system is also subject to other EU legislation requiring a declaration of conformity — such as the Radio Equipment Directive or Machinery Regulation — you can combine all declarations into a single document
The ten-year retention obligation mirrors your technical documentation — store both together in your compliance archive
Treat the declaration as the capstone of your compliance process — if you cannot sign it honestly, you are not ready for market placement

Article 16 — Provider obligations (drawing up the declaration is one of the twelve mandatory obligations)
Article 43 — Conformity assessment (must be completed before the declaration can be drawn up)
Article 18 — Documentation keeping (the ten-year retention obligation applies to both)
Annex V — EU declaration of conformity content (the template that specifies what must be included)

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