Selling AI into the EU from outside it: who answers for a defective product after 9 December 2026

The provisions of Directive (EU) 2024/2853 described below were read in the Official Journal text served by the Publications Office of the European Union on 18 September 2026, and the AI Act provision in section 4 was read at the European Commission AI Act Service Desk on the same date. This article describes Union law only. It does not describe the product liability law of any other jurisdiction, the national measure of any Member State, or the rules on jurisdiction and enforcement of judgments, none of which was read for it. It is not legal advice.

Section 1. A directive with no extraterritorial clause

Article 2(1) states the scope in one sentence: the Directive applies to products placed on the market or put into service after 9 December 2026. The geography is in the definitions. Making available on the market means supply for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge. Placing on the market is the first making available on the Union market. Putting into service is the first use of a product in the Union in the course of a commercial activity where it has not been placed on the market before. Article 4(1) includes software in the definition of product, and recital 13 adds that the mode of supply is irrelevant, whether the software is stored on a device, accessed through a communication network or cloud technologies, or supplied as software as a service. The same recital says that a developer or producer of software, including an AI system provider within the meaning of the AI Act, should be treated as a manufacturer.

Nothing in those provisions depends on where the manufacturer is established. A vendor outside the Union whose AI product is supplied for use on the Union market has placed a product on that market. Article 8(1)(a) makes the manufacturer of a defective product liable, and the provisions that add Union-based defendants are each expressed to be without prejudice to the liability of that manufacturer.

The right belongs to natural persons, and Article 6 confines it to death or personal injury including medically recognised damage to psychological health, damage to property other than property used exclusively for professional purposes, and destruction or corruption of data not used for professional purposes. Financial loss to a business customer is outside the Directive and remains a matter of contract and the general law. A vendor whose product cannot injure a person, damage a consumer's property or destroy a consumer's data has limited exposure under this instrument. A vendor whose product can, such as AI embedded in devices, vehicles, health and wellbeing applications or consumer software, should read the rest closely.

Section 2. The chain inside the Union

Recital 37 gives the purpose: to ensure that injured persons have an enforceable claim where the manufacturer is established outside the Union. Article 8 then sets out who answers, in a structured order.

The importer. Defined in Article 4(12) as any natural or legal person who places a product from a third country on the Union market. Liable under Article 8(1)(c)(i) for a defective product or component.

The authorised representative. Defined in Article 4(11) as any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on that manufacturer's behalf in relation to specified tasks. Liable under Article 8(1)(c)(ii). Recital 37 describes the representative as one appointed in relation to specified tasks under Union legislation, for example under product safety and market surveillance legislation.

The fulfilment service provider. Liable under Article 8(1)(c)(iii) only where there is no importer established within the Union and no authorised representative. The definition in Article 4(13) is built on physical logistics: offering at least two of warehousing, packaging, addressing and dispatching, without owning the product. It is aimed at goods, and it is difficult to see it applying to software delivered over a network.

The distributor. Defined as anyone in the supply chain, other than the manufacturer or importer, who makes a product available on the market. A distributor is liable under Article 8(3) only where no operator from the list above that is established in the Union can be identified, the injured person asks the distributor to identify one or to identify its own supplier, and the distributor fails to do so within one month of receiving the request.

The online platform. Article 8(4) applies the distributor rule to a provider of an online platform that allows consumers to conclude distance contracts with traders and is not itself an economic operator, provided the conditions in Article 6(3) of Regulation (EU) 2022/2065 are fulfilled. Recital 38 explains those conditions as covering a platform that presents the product or enables the transaction in a way that would lead an average consumer to believe the product is provided by the platform itself or by a trader acting under its authority or control. A platform that itself acts as manufacturer, importer, authorised representative, fulfilment service provider or distributor is liable as such.

Two further routes turn a Union business into a manufacturer in its own right. Article 4(10)(b) treats as a manufacturer anyone who has a product designed or manufactured and presents themselves as its manufacturer by putting their name, trademark or other distinguishing feature on it. And Article 8(2) treats as a manufacturer anyone who substantially modifies a product outside the original manufacturer's control and then makes it available or puts it into service. A European reseller that white-labels a foreign AI product, or a systems integrator that rebuilds it for a purpose the vendor's risk assessment did not foresee, is no longer merely part of the chain.

Section 3. The open question: who imports software

The chain was drafted with goods crossing a border in mind, and software strains it at one point. When a vendor outside the Union sells through a Union reseller that contracts with the end customer, the reseller places the product on the Union market and fits the definition of importer. When the vendor contracts directly with Union customers and delivers from its own infrastructure, it is not obvious that anybody else has placed the product on the Union market. The customer has not: a customer that uses the product in its own business may be the person who first puts it into service, but the Directive imposes no liability on a person for putting into service a product it did not manufacture, import or modify.

On a direct-sale model, then, the chain may contain only the manufacturer and, if one has been appointed, its authorised representative. The Directive does not address this case expressly, and this desk does not supply an answer. Article 8(5) recognises that victims may fail to obtain compensation because none of the listed persons can be held liable, and permits, without requiring, Member States to use or establish compensation schemes. Where and how an injured person could sue a manufacturer with no presence in the Union is a question of private international law that this article does not cover. The general problem is discussed in cross-border AI agent liability and conflict of laws.

Section 4. The authorised representative you may already be required to appoint

Article 22(1) of the EU AI Act provides that, 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. The representative performs the tasks specified in the mandate, and under Article 22(4) must terminate the mandate if it considers or has reason to consider that the provider is acting contrary to its obligations under the Regulation. After Regulation (EU) 2026/1744 the high-risk obligations apply from 2 December 2027 for Annex III systems and 2 August 2028 for Annex I products, as set out in the new dates for non-EU operators.

Put that beside the Directive's definition: a person established within the Union who has received a written mandate from a manufacturer to act on its behalf in relation to specified tasks. The AI Act appointment is a written mandate, from a provider the Directive's recital 13 says should be treated as a manufacturer, to a person established in the Union, for specified tasks under Union legislation. On the words of the two instruments, a representative appointed to satisfy the AI Act appears to be an authorised representative for the purposes of Article 8(1)(c)(ii) of the Directive, and so liable, without fault, for damage caused by a defect in the product it represents. That is this desk's reading of the two texts side by side. Neither instrument cross-refers to the other on the point, and no court or authority has been cited for it because none has been found.

If the reading is right, the market for AI Act representation changes character. A representative whose mandate is administrative, such as holding documentation and answering authorities, would carry product liability exposure for bodily injury and property damage caused by a system it did not build and cannot inspect. Firms offering that service can be expected to price it, to require indemnities and evidence of insurance from the provider, and in some cases to decline systems capable of causing physical harm. A provider outside the Union should raise the point with a prospective representative before appointment and not after.

Section 5. What the contract can and cannot do

Article 15 requires Member States to ensure that the liability of an economic operator under the Directive is not, in relation to the injured person, limited or excluded by a contractual provision or by national law. No term in a licence, reseller agreement or representative mandate reduces what the injured person can claim from any operator in the chain.

Between the operators, the position is different. Article 12(1) makes operators liable for the same damage jointly and severally, so the injured person can recover the whole loss from whichever is easiest to reach, which for a product made outside the Union will usually be the importer or representative inside it. Article 14 gives the operator that has paid a right to pursue remedies against the other liable operators in accordance with national law, and that recourse can be shaped by contract. One limit is written into the Directive itself: under Article 12(2), a manufacturer that integrates software as a component has no recourse against the maker of a defective software component where that maker was a microenterprise or small enterprise when it placed the component on the market and the integrating manufacturer agreed by contract to waive the right.

The Union counterparty of a foreign AI vendor will therefore want four things. An indemnity for product liability claims that is not capped at a year of fees. Evidence that the vendor holds liability insurance that responds to bodily injury and property damage caused by software, in the territories concerned, with the limits and the basis of cover stated. A commitment to keep that cover, or run-off, in place for the period of exposure, which under Article 17 is ten years from placing on the market and restarts on substantial modification. And access to technical evidence, because under Article 9 a court can order a defendant to disclose relevant evidence at its disposal, and under Article 10(2)(a) a failure to disclose leads to a presumption that the product was defective. An importer that cannot obtain the manufacturer's test records and logs cannot defend the claim it is jointly liable for.

Why a vendor's insurance certificate is weak comfort on its own, and what to ask for in its place, is set out in your AI vendor's insurance is not your insurance. The interaction between the ten year period and cover bought a year at a time is analysed at agentinsured.eu, on the expiry period and claims-made cover, and the evidence standard at agentcertified.eu, on disclosure and presumptions.

Section 6. Six steps for the vendor outside the Union

1. Decide whether the Directive's heads of damage are reachable. Could a defect in the product kill or injure a person, harm their psychological health in a medically recognised way, damage property that is not exclusively professional, or destroy a consumer's data? If the honest answer is no, the Directive is a secondary concern and contract law remains the main one.
2. Map the chain for each route to market. For each Union reseller, integrator, marketplace and representative, identify which Article 8 role it occupies. Expect each to do the same exercise and to come back with contract requests.
3. Fix the placing dates. The Directive applies to products placed on the Union market after 9 December 2026, and the 1985 directive continues to apply to those placed before. A substantial modification after the date brings a product under the new rules. The analysis is at agentliability.eu, on which regime applies to AI already on the market.
4. Control the modification boundary. State the intended purpose and the permitted configuration in the documentation and the contract, so that it is clear when a partner's changes are within the manufacturer's control and when they are the partner's own substantial modification under Article 8(2).
5. Check the insurance territory and trigger. Confirm with the broker whether existing liability cover responds to a no-fault bodily injury or property damage claim brought in a Member State court in respect of software, and on what basis it is written. This desk has read no policy and asserts nothing about what any wording provides.
6. Build the evidence file to be shareable. Union partners will need it to defend claims. Structure it so that test evidence and version history can be disclosed without handing over model weights or training data.

Section 7. Four steps for the Union counterparty

1. Name your role. Importer, authorised representative, distributor, platform, own-brand manufacturer or modifier. The exposure differs sharply between them, and a distributor's exposure disappears if it can identify, within a month, an operator established in the Union or its own supplier.
2. Keep the supplier records that make that identification possible. Article 8(3) turns on a one month deadline. A distributor that cannot say who supplied a product becomes the defendant.
3. If you are asked to act as an AI Act authorised representative, take advice on the Directive before accepting. The mandate may carry more than the administrative tasks written in it.
4. Do not rely on the vendor's limitation clause, or your own. Article 15 removes both as against the injured person. Rely on indemnity, insurance and evidence.

For smaller European businesses that resell or rebrand AI tools, the plain-language version of the manufacturer question is at insureyouragent.com, on whether the new product liability law applies to a small business using AI. How strict liability for deployers compares across jurisdictions more generally is covered in where strict liability exists.

Section 9. Sources