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Direct answer

We source AI from outside the EU. What do we need to arrange?

This falls under articles 22-25: value chain and authorised representative. That obligation applies from 2 December 2027. There is one exception you have to assess yourself.

This could go the other way

  • Those acting solely as distributor or importer without the Article 25 triggers remain in that lighter role, with their own verification duties.

First step: Assess the value-chain role per system and change.

You describe: You import, distribute or use an AI system from a provider established outside the Union, and want to know which duties land with you. Likely role: deployer (the organisation).

The conclusion and your first steps

This applies now

Coming up

Then there must be a link inside the EU that is answerable: an authorised representative or an importer. Ask your vendor who that is and record it, because without that link you cannot lawfully put a high-risk system into service and you stand alone at an inspection. If you pass the system on within the EU yourself, you can become the importer or even the provider.

Your first actions

  1. Assess the value-chain role per system and change. On white-labelling, substantial modification or purpose change, assess whether your organisation becomes the provider, and arrange the representative for non-EU supply.
  2. Justify the Article 6(3) exception against each individual condition. Name which of the four Article 6(3) conditions you invoke, with facts, and separately justify why the system poses no significant risk of harm to health, safety or fundamental rights and does not materially influence the outcome of decision making.
  3. Take role- and context-specific AI literacy measures. Determine for each role, system and context which combination of instruction, guidance, practice or training is appropriate.
Read the official sourceChecked on

General interpretation, not legal advice. Checked against Regulation (EU) 2024/1689 and the Digital Omnibus (EU) 2026/1744; the official source remains authoritative.

Full map for your situation

Execution

From obligation to arranged and demonstrable

Knowing where you stand is step one. Embed AI translates this obligation into a concrete approach for your organisation: scope, ownership, register and evidence.

See the Embed AI approach
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Zahed Ashkara, lawyer and AI governance specialist

Expert behind this page

Zahed Ashkara

Lawyer and AI governance specialist