Praxikon
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Direct answer

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

This falls under Annex III: high-risk AI. That obligation applies from 2 December 2027. There is one exception you have to assess yourself.

This could go the other way

  • A listed Annex III system may fall outside high-risk under the strict conditions in Article 6(3), except where it profiles. The assessment and registration must be documented.

First step: Justify the Article 6(3) exception against each individual condition.

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 your vendor is directly answerable under the regulation and you can request the required documentation from them. Fix in the contract which documents you receive and within what period: technical documentation, instructions for use and the declaration of conformity are the three that fill your own file.

Your first actions

  1. 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.
  2. 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

Record the classification in an AI register

A classification without a register and ownership is not demonstrable. Embed AI guides classification, register and reassessment in a fixed approach.

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