Role · Importer or distributor

You do not build it. You let it into the market.

An importer brings a third-country provider's system into the Union; a distributor passes it further down the chain. Neither role writes a technical file — both perform checks before placing, and both hold the paperwork for ten years afterwards. Put your own name on it and Article 25 makes you the provider instead.

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Veritome evidence register — files with fingerprints, the clauses each satisfies, scope and status
The reality

What the supply-chain roles miss.

What we hear

“We assumed the CE mark meant the checks were done.”

What the product does

A CE mark is a claim by the provider. Article 23 makes verifying it your duty — the conformity assessment carried out, the technical documentation drawn up, the declaration and the instructions supplied, the authorised representative appointed where required.

What we hear

“We rebranded it, and nothing changed on our side.”

What the product does

Article 25(1)(a) says otherwise. The name on the product moves the whole provider set to you, and the original provider's obligations for that system fall away.

What we hear

“Nobody knew we had to keep the declaration for a decade.”

What the product does

Article 23(5) sets ten years from placing on the market. That outlives most vendor folders, most staff and most document-retention defaults.

What you get

A pre-market check that leaves a record.

01

The verification, as a form

Provider details, authorised representative, CE marking date, declaration reference and market-placement date — structured, so the check is evidence rather than a recollection.

02

Only the supply-chain duties

The engine gives an importer the Article 23 set, not the Annex IV technical file. You never see obligations that belong to whoever built the system.

03

The ten-year clock, held

Article 23(5) retention tracked against the placing date, so the certificate, the instructions and the declaration outlive the folder they arrived in.

04

The Article 25 question, asked

The classification asks whether your name goes on the product — the one question that turns this role into the provider role.

05

Non-conformity, recorded

Where you have reason to believe a system does not conform, the decision not to place it is captured with its reasoning and date.

06

Ready for the authority

Both roles must cooperate and produce information on request. The record is exportable rather than assembled under pressure.

In practice

Where the checks actually bite.

Use case 01

A reseller importing a US vendor's high-risk system.

  • Art. 23 checks recorded before placing — assessment, documentation, CE, declaration.
  • The authorised representative in the Union is named, not assumed.
  • Declaration and instructions retained against the Art. 23(5) ten-year clock.
  • No Annex IV: the technical file remains the provider's obligation.
Veritome evidence register — files with fingerprints, the clauses each satisfies, scope and status
Use case 02

A distributor putting its own brand on a bought model.

  • The branding question in the intake flips the role to provider under Art. 25(1)(a).
  • The obligation set changes on the spot — risk management, Annex IV, conformity, CE.
  • The vendor's file becomes an input to theirs, not a replacement for it.
  • Recognised at classification rather than at audit.
Veritome guided classification — the register wizard that walks Article 5, Annex I, Annex III and the Article 6(3) exception
Use case 03

A reseller who believes a shipped system no longer conforms.

  • The decision not to make it available is recorded with its reasoning and date.
  • The provider and the relevant authority are informed, and that is evidenced.
  • Storage and transport conditions are captured while the system is their responsibility.
  • The trail is hash-chained, so the sequence of what was known when holds up.
Veritome audit log — every change with the user, the timestamp and what changed, hash-chained and anchored daily
Also included

The parts the supply chain reaches for.

Straight answers

Straight answers for the supply chain.

What is the difference between an importer and a distributor?

An importer places on the EU market an AI system bearing the name or trademark of a provider established outside the Union (Art. 3(6)). A distributor is anyone else in the supply chain who makes a system available on the market, other than the provider or the importer (Art. 3(7)). The importer is the first point of entry into the Union; the distributor is a later link in the same chain.

What must an importer verify before placing a high-risk system?

Article 23 requires you to check that the provider has carried out the conformity assessment, drawn up the technical documentation, affixed the CE marking, provided the EU declaration of conformity and the instructions for use, and appointed an authorised representative where required. If you have reason to believe the system does not conform, you must not place it on the market until it does.

How long must an importer keep the paperwork?

Article 23(5) requires the importer to keep a copy of the certificate issued by the notified body where applicable, the instructions for use and the EU declaration of conformity for ten years after the system was placed on the market. Ten years is longer than most document-retention defaults, which is why it is worth recording deliberately rather than assuming the vendor folder survives.

When does a distributor become a provider?

Article 25(1) — if you put your name or trademark on a high-risk system already on the market, substantially modify it, or change its intended purpose so that it becomes high-risk. At that point the provider set applies to you and the original provider's obligations for that system fall away. Rebranding is the most common route, and it is rarely recognised as a compliance event at the time.

Do we have duties after the system is sold?

Yes. Both roles must ensure that storage and transport conditions do not jeopardise conformity while the system is their responsibility, must act where they consider a system non-conforming, and must cooperate with authorities and give them the information needed to demonstrate conformity.

Where to next

Find out whether you are still only a distributor.

One question about branding decides whether you hold the Article 24 duties or the whole provider set. The free check asks it.

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