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.
KEY POINTS AT A GLANCE
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IN SHORT
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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.
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1985 Old PLD in force Directive 85/374/EEC |
2021 EU consultation Reform evaluation launched |
Sept. 2022 Commission proposal New PLD proposed |
Oct. 2024 EP + Council adopts Final trilogue agreement |
Nov. 2024 Published Official Journal of the EU |
Dec. 2026 Transposition deadline National law DE/AT/CH |
from 2027 Application Applies to all new products |
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Scope |
Old PLD (1985) |
New PLD 2024/2882 (effective 2026) |
|---|---|---|
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Material Scope |
Only physical objects (tangible products) |
Also software, AI systems, digital services, raw materials |
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Liability cap |
€85 million cap per claim |
No liability cap – unlimited liability |
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Burden of proof: general rule |
Plaintiff must prove fault, damage, and causation |
Relief from the burden of proof – in many cases, the manufacturer must provide exculpatory evidence |
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Statute of limitations |
3 years from the date of knowledge of the damage, max. 10 years |
3 years from the date of knowledge; 10 years (property damage), 25 years (personal injury in cases of delayed damage) |
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Definition of “manufacturer” |
Only the physical manufacturer of the product |
Also importers, retailers, fulfillment providers, software developers, online marketplaces |
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Digital updates |
Not regulated |
Updates can trigger new liability—even years later |
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Access to evidence |
No right to compel disclosure of manufacturer data |
Plaintiff may seek court order to compel access to manufacturer documentation |
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Property damage threshold |
€500 deductible |
€500 deductible remains – personal injury without deductible |
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AI systems |
Not regulated |
Explicitly covered; high-risk AI with enhanced burden of proof |
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Bold text = significant tightening compared to the old directive. Source: Directive (EU) 2024/2882, EUR-Lex. |
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Dec. 2026 Implementation deadline for all EU Member States Art. 18 Directive 2024/2882 |
Unlimited Scope of liability (no coverage cap anymore) Art. 5 PLD 2024/2882 |
25 years Max. statute of limitations for personal injury Art. 14 PLD 2024/2882 |
3 groups New circumstances for relaxed standards of proof Art. 9 PLD 2024/2882 |
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.
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Scenario |
Burden of proof lies with |
Reason |
Consequences for manufacturers |
|---|---|---|---|
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The plaintiff cannot reasonably obtain evidence on their own (complexity / technical knowledge) |
Manufacturer |
Art. 9(2) PLD: The court may order a reversal of the burden of proof if it is disproportionately difficult for the plaintiff to produce evidence |
Complete production documentation must be available for submission |
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Manufacturer refuses access to relevant documentation |
Manufacturer |
Art. 9(3) PLD: Refusal to produce documents gives rise to a rebuttable presumption of defectiveness |
Obligation to produce documents – the absence of documents is deemed an admission of fault |
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High-risk AI system causes harm (AI Act Annex III) |
Manufacturer |
Art. 9(4) PLD in conjunction with the AI Act: In the case of high-risk AI, automatic relaxation of the burden of proof for fault and causation |
Complete AI system description, training data documentation, and proof of compliance required |
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The error was obviously known at the time of placing on the market |
Plaintiff |
Standard burden of proof remains with the plaintiff – manufacturer does not have to prove anything |
No additional documentation requirement, but quality records provide protection nonetheless |
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Damage caused by a software update after the product was placed on the market |
Plaintiff |
Plaintiff must prove causality between the update and the damage – but manufacturer must submit update documentation |
Complete update versioning and change log required |
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THE MOST IMPORTANT MISCONCEPTION REGARDING THE BURDEN OF PROOF Many companies believe: 'We didn’t do anything wrong, so we don’t have to prove anything.' That is incorrect under the new PLD. The relaxation of the burden of proof means: If a court determines that a plaintiff does not reasonably have access to evidence—e.g., because they are unfamiliar with a manufacturer’s production processes—the court may require the manufacturer to prove its own lack of fault. Anyone who has not documented their manufacturing processes cannot provide this proof—regardless of whether the product was actually defective. |
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.
| Category | Content |
|---|---|
| Objective | The basis of any liability defense |
| Required evidence / documents | Technical documentation in accordance with the EU Directive; Declaration of Conformity; Risk Assessment; Design Change History; Safety Test Reports |
| Penalty for non-compliance | No proof of faultlessness at the time of placing on the market → Liability by presumption |
| Category | Content |
|---|---|
| Objective | Proof of the correct manufacture of the individual item |
| Required evidence / documents | Work instructions; production approvals; process parameters; test results; calibration certificates; deviations and special approvals |
| Penalty for non-compliance | No evidence that a defect can be ruled out at the time of manufacture |
| Category | Content |
|---|---|
| Objective | Proof of Flawless Raw Materials |
| Required evidence / documents | Batch numbers; incoming goods inspections; serial number traceability; material certificates; supplier audits; release decisions |
| Penalty for non-compliance | Defective materials cannot be ruled out |
| Category | Content |
|---|---|
| Objective | Proof of compliance with active surveillance obligations |
| Required evidence / documents | Complaint register; 8D reports; field data; warranty claims; CAPA documentation; regulatory reports |
| Penalty for non-compliance | Failure to demonstrate market surveillance = negligence despite known risk |
| Category | Content |
|---|---|
| Objective | Evidence for digital products under the new PLD |
| Required documentation | Software version logs; requirements documentation; test logs; AI model documentation; SBOM |
| Penalty for non-compliance | No evidence as to which release may have caused the damage |
| Category | Content |
|---|---|
| Objective | Records must be accessible and unaltered |
| Required evidence / documents | Audit-proof storage; immutability; audit trail; quick accessibility; digital signatures and timestamps |
| Penalty for non-compliance | Documentation that cannot be retrieved or has been altered is worthless in court |
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.
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Liability Issue |
Burden of proof |
Supporting Document |
Where in CSP IPM |
|---|---|---|---|
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Was the product free of defects when it was placed on the market? |
Manufacturer (in cases of relaxed burden of proof) |
Final test report + acceptance approval per serial number |
CSP IPM: Test results per serial number |
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Were the correct materials used? |
Manufacturer |
Batch linkage: Material → Product + Supplier certificates |
CSP IPM: Material traceability |
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Did the machine operate correctly? |
Manufacturer |
Process parameter log + machine calibration certificate |
CSP IPM: Machine data log |
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Was the design safe for the intended use? |
Plaintiff (but the manufacturer must provide documentation) |
Technical documentation + risk assessment + CE documentation |
Document management / QM system |
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Was the manufacturer aware of field issues and failed to respond? |
Plaintiff |
CAPA register + evidence of corrective actions + reports to authorities |
CSP IPM: CAPA module + complaint register |
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Which software version was installed in the product? |
Manufacturer (requirement to document updates) |
Software version log + test report for the specific version |
Version control + Test management system |
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Was the product properly installed/used? |
Plaintiff |
Delivery documentation + operating instructions + maintenance records |
Delivery note archive + operating instructions |
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Was the production batch homogeneous and free of defects? |
Manufacturer |
Statistical Process Control (SPC) + Batch Test Report |
CSP IPM: SPC analysis per batch |
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.
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Risk |
Product Type |
Why high risk |
Minimum documentation |
|---|---|---|---|
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CRITICAL |
Class II/III medical devices, high-risk AI, vehicle safety systems |
High probability of personal injury, 25-year statute of limitations, relaxed burden of proof (AI Act), unlimited liability |
Full serialization, complete audit trail per unit, post-market surveillance, mandatory reporting to authorities |
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HIGH |
Safety-critical automotive parts, electrical appliances, industrial equipment, food contact |
Mass-produced goods with high volume, broad exposure, potential for personal injury |
Seamless batch tracking, process parameter recording, complaint history with CAPA |
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MEDIUM |
Capital goods, mechanical engineering, B2B components, software systems (not high-risk) |
Property damage is typical; personal injury is rare; plaintiffs are usually companies with access to their own evidence |
Complete design documentation, acceptance reports, supplier documentation |
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LOW |
Simple consumer goods, standardized purchased parts, office supplies |
Low amount of damages, plaintiff bears full burden of proof, no grounds for relaxation of the burden of proof |
Batch records, declaration of conformity – no extended manufacturing documentation required |
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
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?
What is not considered a product?
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THE SPECIAL PROVISION FOR SOFTWARE UPDATES If a software update introduces a new defect after the product has been placed on the market, the update provider may be liable for resulting damages—even if the original product was defect-free. This means: Every software update triggers a new chain of liability. Without complete documentation of the update changes, test reports, and version history, a manufacturer cannot prove what was changed in which version. For manufacturing facilities with embedded control software: Every firmware update for delivered machines is a new potential source of liability. The documentation requirement starts anew from the time of the update. |
December 2026 sounds far away. It isn’t. Those who start building their documentation infrastructure today will have just enough time to fully implement the six mandatory areas. Those who start in 2026 will be working reactively and under time pressure.
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Action |
Priority |
Timeframe |
Who is responsible |
|---|---|---|---|
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PLD Gap Analysis: Inventory of all currently missing documentation components |
Immediately |
0–4 weeks |
QM Manager + Legal Department |
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Download the audit toolkit and compare it with the current documentation status |
Immediately |
0–2 weeks |
QM Manager |
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Review and adjust retention periods: 10 years (property damage), 25 years (personal injury) |
High |
1–3 months |
IT + Archives + Legal |
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Implement or upgrade an audit-proof archiving solution |
High |
2–6 months |
IT Manager + QM |
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Activate complete process parameter recording (MES/IPM integration) |
High |
3–9 months |
Production + IT |
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Batch/serial number traceability: all levels (material → assembly → finished product) |
High |
3–9 months |
QM + Production |
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Introduce software version management (embedded software, updates) |
Medium |
4–12 months |
IT + Development |
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Formalize post-market surveillance process (CAPA, complaint register, field data) |
Medium |
6–12 months |
QM + Sales |
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Extend supplier audits to include PLD-compliant documentation |
Medium |
6–18 months |
Purchasing + QM |
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Compliance check December 2026: Completeness review of all obligation groups |
Completion |
Nov./Dec. 2026 |
QM Manager + Legal |
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PRACTICAL TIP Integrated production management with seamless proof of liability IPM documents manufacturing processes, test results, and traceability in an audit-proof, immutable, and retrievable manner—exactly as required by the new EU Product Liability Directive in the event of a liability claim. From material receipt to delivery.
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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.