EU Product Liability Directive 2026: What Manufacturers Must Document

On November 18, 2024, the new EU Product Liability Directive (Directive 2024/2882) was published in the Official Journal of the European Union. Member States have until December 9, 2026, to transpose it into national law. For manufacturing companies, this means less than two years to implement fundamental changes to product documentation, the burden of proof, and the liability framework.

The core problem: Many manufacturers underestimate what the new directive actually requires of them. The old PLD from 1985 was comparatively straightforward. The new PLD expands the definition of a product to include software and AI, shifts the burden of proof under certain conditions in favor of the injured party, and increases the pressure on manufacturers to document their manufacturing processes comprehensively—not as an end in itself, but as a protective measure in the event of liability.

This article explains what the new PLD specifically changes, what documentation obligations arise for manufacturing companies—and what a structured documentation framework looks like that will hold up in the event of liability.

What has really changed? A comparison of the old PLD and the new PLD

The 1985 Product Liability Directive was one of the EU’s oldest and least-amended legal instruments. For 39 years, it defined the basic logic of product liability in Europe—while failing to address the digital reality of the 21st century. The new PLD (2024/2882) is not a revision. It is a fundamental overhaul.

The Shift in the Burden of Proof: What This Means for Manufacturers

The most important change in the new Product Liability Act—one that many companies still underestimate—is the new rule regarding the burden of proof. Under the old Product Liability Directive (PLD), the rule was: Anyone claiming product damage must prove that the product was defective and that this defect caused the damage. This was a high hurdle for plaintiffs.

The new PLD recognizes three scenarios in which this burden of proof is reversed or eased. For manufacturers without complete documentation, this means: They must actively prove that their product was free of defects at the time it was placed on the market—and they cannot do so without comprehensive manufacturing documentation.

The six documentation requirements that now apply

The interplay of the new PLD provisions, the rules on the relaxation of the burden of proof, and the obligation to produce documents results in six specific groups of documentation requirements for manufacturing companies. None of these is optional—they all address potential points of vulnerability in the event of liability.

Requirement 01: Product design and conformity documentation

Obligation 02: Manufacturing process documentation

Requirement 03: Traceability of Materials & Components

Requirement 04: Post-market surveillance and field data

Requirement 05: Software and update documentation

Requirement 06: Storage and access infrastructure

Evidence Matrix: What Is Specifically Requested in the Event of Liability

In a liability case, the court or the plaintiff’s attorney will ask specific questions. For each question, there is one or more pieces of evidence that exonerate the manufacturer. The following matrix outlines the most important questions and the documents required to answer them.

Liability Risk by Product Type and Industry

The new PLD applies to all products—but the liability risk is not equally high for all manufacturers. It depends on three factors: How severe is the potential damage? How likely is a product defect? And how robust is the documentation that enables a defense against liability? The following overview classifies typical product categories according to their liability risk level under the new PLD.

In a liability case, what really happened is not what matters. What matters is what can be proven. And evidence is created in manufacturing—not in the legal department.

— Korbinian Hermann, Managing Director, CSP Intelligence GmbH

Digital Products and Software: What Manufacturers Need to Know

The expansion of the definition of “product” to include software and digital services is the most significant structural change in the PLD 2024. Until now, software manufacturers were considered largely protected—software was not a “product” in the legal sense of liability. That has changed.

What counts as a “product” under the new PLD?

• Embedded software (firmware in machines, control software, medical software)
• Standalone software capable of causing physical harm (production planning systems, autonomous systems)
• AI models and systems, particularly high-risk AI as defined in AI Act Annex III
• Software updates and patches provided after the product has been placed on the market
• Digital twins and simulation models that inform safety decisions

What is not considered a product?

• Open-source software provided without commercial transactions (with narrow exceptions)
• Purely informational offerings without any production or control functions
  

Frequently Asked Questions

Does the new PLD also apply to B2B suppliers who do not manufacture end products?

Yes—but with one important difference. The PLD governs liability toward end users who have suffered harm (consumers and businesses that do not further process the product). If a Tier 2 supplier delivers a defective component that is installed in an OEM’s end product and causes damage to the end customer, the OEM can be held liable as the manufacturer of the end product—and subsequently seek recourse from the Tier 2 supplier. Component suppliers therefore face indirect liability risks and direct documentation requirements arising from supplier agreements.

When does the new PLD take effect—immediately upon implementation or only for new products?

The PLD applies from the implementation date to all products placed on the market thereafter. Products placed on the market before the national implementation date (December 2026) are still subject to the old PLD. However: Since software updates can trigger a new chain of liability, a product shipped before 2026 may fall under the new PLD after 2026 due to an update. This is a key consideration for manufacturers with long product lifecycles and regular updates.

What does “placing on the market” mean for Software-as-a-Service?

This is one of the outstanding questions of interpretation. The PLD covers software that is integrated into a product or that takes control of a product—typically embedded software and control software. SaaS services that offer pure information processing without physical product control may not be fully covered. The specific scope will be gradually clarified by national courts and EU case law through 2027/28. Manufacturers of industrial software should assume inclusion in cases of doubt.

How long must manufacturing documentation be retained?

The new PLD sets two limitation periods: 10 years from the date of placing on the market for property damage and financial loss, and 25 years for personal injury where symptoms do not appear until many years later (delayed effects). For manufacturers of products posing a risk of personal injury—in effect, all product categories except pure information services—the retention period should be at least 25 years. GoBD requires a 10-year retention period for tax-related documents; the PLD goes beyond this for documents relevant to liability.

What is the “document disclosure obligation,” and how can I prepare for it?

Section 8 of the Product Liability Act (PLD) grants plaintiffs the right to request access to relevant manufacturer documentation. A court may order the manufacturer to produce this documentation. If the manufacturer refuses to produce the documentation without good cause, the product is presumed to be defective. Preparation means: All relevant manufacturing documents must be archived in such a way that they can be quickly and completely compiled by serial number or batch. CSP IPM allows exactly that: an export of all relevant records per unit in just a few minutes.

What changes for importers of non-European products?

Under the new PLD, importers are treated as manufacturers if the original manufacturer is based outside the EU and does not have an EU representative. This means that EU importers of non-EU products are liable in the same way as manufacturers and must provide the same documentation. This represents a significant new risk for many trading companies that import and sell products from Asia—especially if the original manufacturer’s documentation is not in a PLD-compliant format.

How is the new PLD related to the EU AI Act?

The EU AI Act (in effect since August 2024) and the new PLD are interlinked. The AI Act defines which AI systems are considered “high-risk” (Annex III: healthcare, mobility, critical infrastructure, employment, etc.). The new PLD automatically grants the plaintiff a reduced burden of proof in cases of harm caused by high-risk AI systems. For manufacturers using AI in these high-risk categories, this creates a direct duplication of documentation requirements: the AI Act requires technical documentation, while the PLD turns this documentation into a liability protection tool.

Is ISO 9001 certification sufficient as proof of documentation?

No – ISO 9001 certifies the existence of a quality management system, but does not provide concrete evidence for a specific product or batch. In the event of a liability claim, the court will ask for specific records of process parameters, test results, and traceability evidence for the product that caused the damage—not for a system certificate. ISO 9001 is a necessary foundation, but it does not provide sufficient liability protection. The new PLD requires documented evidence at the product and unit level.