DepthThe conclusion and your first steps
Direct answer
We source AI from outside the EU. What do we need to arrange?
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).
This applies now
- Article 4: AI literacyApplicable
Coming up
- Articles 22-25: value chain and authorised representativefrom 2 December 2027
- Annex III: high-risk AIfrom 2 December 2027
A provider established outside the Union must appoint an authorised representative in the EU before a high-risk system is placed on this market. Without one, you as importer or distributor can end up in the provider role yourself, with all the documentation and conformity duties that carries. Check this before purchase and record it contractually.
Your first actions
- 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.
- 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.
- 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.
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