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AI Act · Authorised representative · AESIA · EU establishment

Do you need an EU entity to sell AI in Europe? The authorised representative question.

Most AI Act coverage is about conformity assessment. The obligation that actually stops a non-EU company at the border is simpler: before you place the system on the Union market, you need someone established in the Union who answers for it.

Establish your EU entity in Spain ↗ Entity, representation and registration as one file
GPAI model providers
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Obligations, including EU representation for third-country providers, applicable since 2 August 2025.
High-risk — Annex III
2 Dec 2027
Deferred from August 2026 by the AI Act simplification package agreed in 2026.
High-risk — Annex I
2 Aug 2028
AI embedded in products already regulated under Union harmonisation law.

A company in San Francisco, Tel Aviv, London or Singapore builds an AI product, signs its first European customers and starts reading about the AI Act. Almost everything it finds is about risk classification, technical documentation and conformity assessment — work that is real, expensive and, for most companies, not the first thing that becomes due.

The first thing that becomes due is structural. The AI Act, like the rest of EU product law, is built on a simple premise: for anything placed on the Union market, there must be a person established in the Union who can be addressed by the authorities. If your company has no EU establishment, that person does not exist yet — and creating it is a corporate decision, not a compliance one.

Article 22: the authorised representative for high-risk providers.

Article 22 of the AI Act is short and unambiguous. Prior to making their high-risk AI systems available on the Union market, providers established in third countries shall, by written mandate, appoint an authorised representative established in the Union. Not after the first sale. Not on request from a regulator. Before.

The mandate is not a formality either. Under Article 22 the representative is empowered and required to:

  • Verify that the EU declaration of conformity and the technical documentation have been drawn up and that an appropriate conformity assessment procedure was carried out.
  • Keep the documentation at the disposal of competent authorities for ten years after the system is placed on the market.
  • Be addressed by the authorities — in addition to, or instead of, the provider — on all issues relating to compliance.
  • Cooperate with competent authorities on any action taken in relation to the system, including risk mitigation.
  • Comply with registration obligations, or verify that the provider has done so.
  • Terminate the mandate and immediately inform the market surveillance authority, with reasons, if it has reason to consider the provider is acting contrary to its obligations.
Read the last one again

The representative has a duty to report its own client.

That single provision is what separates a real authorised representative from a mailbox service. A provider appointing a representative is appointing a party with an independent statutory obligation to walk away publicly if the provider does not hold up its end. Choose accordingly — and expect any serious representative to conduct real diligence before accepting the mandate.

Article 54: GPAI models — and this one is already live.

Article 54 imposes the parallel requirement on providers of general-purpose AI models established outside the Union: appoint, by written mandate, an authorised representative established in the Union before placing the model on the EU market. Obligations for GPAI model providers have applied since 2 August 2025.

This is the part most companies have missed, because the public conversation has been dominated by the high-risk timetable. If you provide a general-purpose model into the EU from a third country, the representation requirement is not a 2027 problem. It is a current one.

What the 2026 deferral did and did not change.

In November 2025 the European Commission proposed a simplification package deferring the high-risk compliance dates. The European Parliament endorsed it in June 2026 and the Council gave final approval on 29 June 2026. The result is more time on one track and no change on the others.

ObligationApplies fromStatus
Prohibited practices, AI literacy2 February 2025In force
GPAI model provider obligations, incl. EU representative2 August 2025In force
Governance, national authorities, penalties framework2 August 2025 onwardIn force
High-risk — standalone systems (Annex III)2 December 2027Deferred
High-risk — AI in regulated products (Annex I)2 August 2028Deferred

The deferral bought engineering time. It did not remove the requirement, and it did not touch the GPAI track. For a company whose EU market entry is a live commercial question, the useful reading is the opposite of relief: there is now a window in which the structural work can be done calmly, before the technical work becomes urgent. That window closes on its own.

Representative, subsidiary, or both?

The two instruments answer different questions. An authorised representative gives the authorities a party to address; it does not give the company a European balance sheet, a European bank account, a VAT number or the ability to contract as an EU counterparty. An EU subsidiary gives all of that — and, depending on how the product is placed on the market, may change which role the group occupies under the Act.

Which do you need
Third-country provider, selling into the EU remotely, no EU presence planned
Authorised representative
Selling into the EU and needing to invoice in euro, hold a bank account and sign EU contracts
EU entity
Hiring in the EU, or wanting EU customers to contract with an EU counterparty
EU entity
Group headquartered outside the EU with an EU operating subsidiary
Entity, plus representation mapped to the actual provider
GPAI model provider outside the EU
Representative — already required

Which role a company occupies — provider, deployer, importer, distributor — is a question of fact, not of preference, and it drives everything downstream. Getting the role assignment wrong is the most common structural error, and it is the one that is most expensive to unwind after contracts are signed.

Why Spain: the regulator exists and answers the phone.

Member States were required to designate their national competent authorities — market surveillance and notifying — by 2 August 2025. Most did not. Reporting through early 2026 put the number of Member States that had designated both at around nine out of twenty-seven. For a company choosing where in the EU to establish, that is not a trivia point. It determines whether there is an authority to register with, ask, and be answered by.

01
A dedicated agency, not a side deskAESIA — the Agencia Espanola de Supervision de la Inteligencia Artificial — was created by Royal Decree 729/2023 and became operational in 2024, the first supervisory body in the EU dedicated specifically to AI.
02
Published guidance and a sandboxSpain has issued practical guidance for companies and operates a regulatory sandbox for AI — a route to engage with the regulator before enforcement rather than after.
03
A single point of contact that existsAESIA acts as Spain's central coordination point on AI supervision and its interlocutor in EU-level AI governance, alongside sector authorities such as the AEPD, Banco de Espana and CNMV.

Spain has also moved on the national implementing law. A Proyecto de Ley Organica on the good use and governance of AI — designating supervisory authorities and establishing a national penalty regime with fines reported up to €35 million or 7% of worldwide turnover for prohibited practices — was approved by the Council of Ministers on 26 May 2026 and is in parliamentary process. It is not yet in force, and anyone telling you otherwise is selling something. What matters commercially is the direction: Spain is building the enforcement architecture ahead of most of the Union, not behind it.

What a representative is not.

Not this

A registered address with a forwarding rule

Ten years of technical documentation held at the disposal of authorities, a duty to cooperate on risk mitigation and a statutory obligation to terminate and report cannot be discharged by a mailbox and an email alias.

This

A mandated party with capacity and cover

Written mandate, documented intake diligence, secure retention of the technical file, a named contact able to engage with market surveillance, and professional indemnity behind the role.

The same distinction runs the other way. A provider should expect a representative to ask hard questions before signing — about classification, documentation and conformity — because the representative is accepting a public obligation, not a subscription.

The sequence.

Step 01
Establish the role and the classificationProvider or deployer. GPAI model, high-risk system, limited-risk with transparency duties, or out of scope. Everything else follows from this, and it is a legal question about facts — not a marketing decision.
Step 02
Decide entity, representation, or bothCommercial needs — invoicing, banking, hiring, contracting — usually decide this before the AI Act does. Where an EU entity is being formed anyway, the representation question folds into it.
Step 03
Incorporate and activateFor a Spanish SL: NIE for shareholders and administrador, escritura, Commercial Registry, Modelo 036 with correct activity codes, VAT and ROI where intra-community supply is expected, and banking.
Step 04
Execute the mandate and set up retentionWritten mandate meeting Article 22 requirements, a copy to the authorities on request, and an actual system for holding the technical documentation for ten years.
Step 05
Registration and ongoing contactEU database registration where applicable, contact details published and kept current, and a working channel to the competent authority before it needs one.
The takeaway

The compliance work has moved to 2027. The corporate work has not.

An EU entity takes weeks to incorporate and months to bank properly. A representation mandate requires a counterparty willing to accept statutory exposure. Neither is something to start in the quarter the deadline lands — and for GPAI providers, the deadline already has.

Position as at July 2026, reflecting Regulation (EU) 2024/1689 and the AI Act simplification package approved by the Council on 29 June 2026. The Spanish implementing law remains in parliamentary process. This is general information, not legal advice — role classification, risk classification and representation requirements are fact-specific and require professional review.

Someone in the Union has to answer for it. Decide who, before you ship.

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