The Product Liability Directive: what an integrator owns after 9 December 2026

A robot deployment generates a conformity file: the risk assessment, the harmonised standards applied, the technical documentation, the declaration and the mark. From 20 January 2027 that file is governed by Regulation (EU) 2023/1230, and the question it answers is whether the machine may lawfully be placed on the market and put into service.

Directive (EU) 2024/2853 answers a different question. Article 1 states its subject matter as the liability of economic operators for damage suffered by natural persons and caused by defective products. It is compensation law. A complete conformity file does not dispose of it, and Article 7(2)(f) makes the point from the other direction: relevant product safety requirements are one of the circumstances a court weighs when assessing defectiveness, not a defence that ends the assessment.

The two files also disagree about who the defendant is. Under conformity law the person who places the machine on the market carries the obligations. Under the Directive, Article 8 names a list — the manufacturer of the product, the manufacturer of a defective component integrated within the manufacturer's control, and, where the manufacturer sits outside the Union, the importer, the authorised representative, or, failing both, the fulfilment service provider. An integrator can land on that list without ever having built a machine.

The operative sentence is short. Article 8(2): any natural or legal person that substantially modifies a product outside the manufacturer's control and thereafter makes it available on the market or puts it into service is considered to be a manufacturer of that product for the purposes of paragraph 1.

Everything therefore turns on substantial modification, which Article 4(18) defines in two steps. First, a modification is substantial if it is considered substantial under the relevant Union or national product safety rules. Second, where those rules lay down no threshold, a modification is substantial if it both changes the product's original performance, purpose or type without that change having been foreseen in the manufacturer's initial risk assessment, and changes the nature of the hazard, creates a new hazard or increases the level of risk.

Both limbs have to be met on the second route. A change that alters performance but leaves the hazard picture where the OEM's risk assessment already put it is not a substantial modification under Article 4(18)(b). Recital 39 confirms the boundary from the other side: economic operators that carry out repairs or other operations that do not involve substantial modifications should not be subject to liability under the Directive.

For an integration practice, the honest reading is that most of what werob does sits on the safe side of that line and some of it does not. Commissioning a serving robot to a floor plan, tuning a cleaning route, wiring a job schedule to a POS or a facility system: none of that changes performance, purpose or type against the OEM's risk assessment, and none of it changes the hazard. Fitting a payload the OEM never assessed, defeating or re-scoping a safety function, combining two machines into an assembly that behaves as one, or adding an autonomy layer that makes decisions the OEM's assessment did not contemplate: those are the cases where Article 4(18)(b) can be satisfied on both limbs, and the CE consequences under the Machinery Regulation usually arrive at the same time.

Article 4(1) defines a product as all movables, including electricity, digital manufacturing files, and software. Article 4(3) makes a related service — a digital service integrated into or inter-connected with a product such that its absence would stop the product performing a function — a component of that product under Article 4(4).

That closes a gap an integrator might otherwise assume was open. Recital 40 states that the same principles apply to modifications made by way of a software update or upgrade as to modifications made in other ways, and that where a substantial modification is made through an update or through the continuous learning of an AI system, the modified product is treated as made available on the market or put into service at the moment that modification is actually made. A fleet-management layer pushed to a hundred machines in service is capable of being the act that makes the pusher a manufacturer of all hundred.

Article 11(2) removes the obvious escape. An operator cannot rely on the defence that the defectiveness came into being after the product was placed on the market where the defectiveness is due to a related service, to software including updates or upgrades, to a lack of updates necessary to maintain safety, or to a substantial modification — provided these are within the manufacturer's control. Article 4(5) defines that control broadly: it exists where the manufacturer performs, authorises or consents to the integration or supply of a component, and where the manufacturer has the ability to supply updates itself or via a third party.

Free and open-source software developed or supplied outside a commercial activity is outside the Directive entirely under Article 2(2). Software supplied in the course of a commercial activity is not.

Robot hardware in this market is frequently manufactured outside the Union. Article 8(1)(c) is written for exactly that: where the manufacturer of a product or component is established outside the Union, and without prejudice to that manufacturer's own liability, the importer is liable, the authorised representative is liable, and where there is no Union-established importer and no authorised representative, the fulfilment service provider is liable.

Article 4(12) defines an importer as any person who places a product from a third country on the Union market. An integrator that brings machines in directly rather than buying from an established EU entity is that importer, and inherits manufacturer-level exposure without having modified anything. The same integrator buying the identical machine from an OEM's European subsidiary does not.

Distributors sit one step back but are not out of reach. Under Article 8(3), where no Union-established operator from the Article 8(1) list can be identified, each distributor is liable if an injured person asks it to identify such an operator or its own supplier and it fails to do so within one month of the request. Article 8(4) extends the same rule to providers of online platforms in the circumstances set out in Article 6(3) of Regulation (EU) 2022/2065.

One month is short for a supply-chain question about a machine delivered years earlier. The practical consequence is a records question rather than a legal one: knowing, per serial number, who the EU-established operator was.

Two limits in the Directive materially narrow the exposure on a commercial deployment, and both are easy to overstate in either direction.

Article 5(1) confines the right to compensation to a natural person who suffers damage. A customer company cannot bring a claim under the Directive against werob for a defective robot; that relationship is governed by contract and by national non-contractual law, which Article 2(4)(b) expressly leaves untouched.

Article 6(1) then limits the heads of damage to death or personal injury including medically recognised damage to psychological health; damage to or destruction of property, excluding the defective product itself, a product damaged by a defective component integrated by its own manufacturer, and property used exclusively for professional purposes; and the destruction or corruption of data that are not used for professional purposes.

On a hotel floor, a care home corridor, a hospital or a commercial kitchen, that combination points in one direction. The property head is largely closed, because the plant a robot is likely to damage is professional property. The data head is largely closed for the same reason. What remains open, and is the reason the Directive matters at all in these settings, is personal injury to the natural persons who are always present: residents, patients, guests, and the customer's own staff.

Article 15 completes the picture. Member States must ensure that liability under the Directive is not limited or excluded, as against the injured person, by a contractual provision or by national law. A limitation clause in the integration contract does not reach the injured person. It can only affect the recourse position between operators under Article 14, and under Article 12(1) operators liable for the same damage can be held jointly and severally liable.

Article 9(1) requires a defendant to disclose relevant evidence at its disposal once a claimant has presented facts and evidence sufficient to support the plausibility of the claim. Disclosure is limited to what is necessary and proportionate under Article 9(3), and Article 9(4) and 9(5) require courts to weigh the protection of confidential information and trade secrets and to take specific measures to preserve confidentiality.

The consequence of not disclosing is set out in Article 10(2)(a): where the defendant fails to disclose relevant evidence pursuant to Article 9(1), the defectiveness of the product is presumed. Defectiveness is also presumed where the claimant shows the product did not comply with mandatory safety requirements intended to protect against the risk of the damage suffered, or where the damage was caused by an obvious malfunction during reasonably foreseeable use. Article 10(4) allows a court to presume defectiveness or causation where the claimant faces excessive difficulties, in particular due to technical or scientific complexity, and shows that defectiveness or causation is likely. Article 10(5) preserves the right to rebut every one of these.

This changes what the integration record is for. A commissioning file, a parameter history, a route configuration and an update log are already kept as engineering artefacts. Under Article 10 they become the material that rebuts a presumption, and under Article 11(1)(g) they carry a specific defence: a person who modified a product under Article 8(2) is exempt if it proves that the defectiveness that caused the damage relates to a part of the product not affected by the modification. That defence is only available to someone who can show precisely what was touched and what was not.

Article 16(1) sets a limitation period of three years running from the day the injured person became aware, or should reasonably have become aware, of the damage, the defectiveness and the identity of the liable operator.

Article 17(1) sets an expiry period of ten years, running from the date the defective product was placed on the market or put into service — or, under Article 17(1)(b), in the case of a substantially modified product, from the date that product was made available or put into service following its substantial modification. Article 17(2) extends the period to twenty-five years where the injured person could not initiate proceedings within ten years due to the latency of a personal injury.

The restart in Article 17(1)(b) is the sting for a retrofit practice. Recital 58 explains the reasoning plainly: substantially modified products are essentially new products, so a new expiry period should start to run, for example as a result of remanufacturing; updates or upgrades that do not amount to a substantial modification do not affect the expiry period of the original product. A machine bought in 2027 and substantially modified in 2032 carries a ten-year clock to 2042, and it runs against the modifier.

Article 2(1) and Article 21 together produce the transitional picture. The Directive applies to products placed on the market or put into service after 9 December 2026; Directive 85/374/EEC is repealed with effect from that date but continues to apply to products placed on the market before it. Article 22(1) sets the same date as the transposition deadline for Member States, and Article 18(1) requires any Member State wishing to maintain an existing derogation from the development risk defence to notify the Commission by that date. A fleet that spans the boundary is a fleet under two regimes, distinguished by placing-on-the-market date, for as long as the older units remain in service.

None of this argues against integration work, and it does not turn an integrator into a manufacturer by default. Recital 39 is explicit that repairs and operations short of substantial modification stay outside the Directive, and the ordinary content of a deployment — siting, routing, scheduling, connecting to the customer's operational systems — does not meet the Article 4(18)(b) test on both limbs.

What it does change is that a small number of decisions now carry a consequence they did not carry before, and they are identifiable in advance. Whether a payload or attachment falls inside or outside the OEM's risk assessment. Whether an autonomy or fleet layer alters the hazard picture. Whether the machine was imported directly or bought from an EU-established entity. Whether, per serial number, the record shows what was modified and what was not.

werob is hardware-agnostic, which in this context is a liability position as much as a commercial one: the choice of whether to source through an EU-established operator, and whether a requested modification is worth crossing the Article 8(2) line for, is made before the machine ships rather than after an incident. The conformity file and the CE decision still have to be right. They simply no longer answer the question the Directive asks.