WHAT THE ARTICLE IS ABOUT
The EU gateway requirement for non-EU AI providers
Article 22 establishes the authorised representative requirement for providers of high-risk AI systems who are not established in the EU. It mirrors a common mechanism used across EU product safety law — ensuring that every high-risk AI system on the EU market has an identifiable, legally responsible party within EU jurisdiction that regulators can engage with directly.
WHAT IT SAYS
Mandatory appointment, written mandate, full liability
- Providers established outside the EU must appoint, by written mandate, an authorised representative established in the EU before placing their high-risk AI system on the market or putting it into service in the EU
- The authorised representative must be named in the documentation accompanying the AI system
- The representative is responsible for performing and carrying out on the provider’s behalf the obligations and procedures established by the Act — including cooperation with authorities, maintaining documentation, and handling conformity assessments
- The representative must have sufficient powers and resources to fulfil these obligations and must be able to respond to authority requests even if the provider is unresponsive or unreachable
- If the provider fails to comply with the Act, the authorised representative may be held liable for the non-compliance alongside the provider
- The appointment does not relieve the provider of its own obligations — both remain responsible
WHO IS AFFECTED
Every non-EU provider of high-risk AI placing systems on the EU market
- US, UK, Asian and all other non-EU companies whose high-risk AI systems are used in the EU
- Authorised representatives themselves — legal or natural persons in the EU who accept these mandates and the liability that comes with them
- EU importers who sometimes also act as authorised representatives
- National competent authorities who deal with the representative rather than the non-EU provider directly
WHAT IT MEANS FOR SMES
Non-EU SMEs: appoint before you launch, not after
- If you are a non-EU business selling high-risk AI to EU customers, this article is non-negotiable — you cannot place your system on the EU market without an appointed representative
- The representative can be a law firm, a compliance consultancy, or any EU-established legal entity willing to accept the mandate in writing
- Choose your representative carefully — they carry real liability and must have genuine capacity to respond to regulatory requests on your behalf
- The cost of appointing a representative is small compared to the penalty for operating without one — fines for non-compliance can reach up to 15 million euros or 3% of global annual turnover
- EU-based SMEs are not subject to this article — it applies only to providers established outside the EU
Related Articles
- Article 2 — Scope (establishes that non-EU providers are in scope when their systems are used in the EU)
- Article 16 — Provider obligations (the representative fulfils these on the provider’s behalf)
- Article 21 — Cooperation with competent authorities (the representative handles this)
- Article 23 — Obligations of importers (importers can also serve as authorised representatives)
