Briefing
Product Liability Directive and the Manual

The Short Answer
Your Manual Becomes Evidence
The new Product Liability Directive replaces Directive 85/374/EEC for products placed on the market or put into service after 9 December 2026 (Articles 2(1) and 21). It covers software (Article 4(1)). In deciding whether a product is defective, Article 7(2)(a) lists the instructions for its assembly, installation, use and maintenance among the circumstances to weigh.
For a documentation team the shift is practical. The manual is not only a deliverable; it can be one of the documents in a dispute, and so can the record of how it was written, approved, and issued. This article reads the Directive from that angle.
This page explains the Directive; it is not legal advice. Read the text and talk to counsel about your products.
Dates
Which Products Fall Under It
The line is the placing-on-the-market date of each unit. The Directive applies to products placed on the market or put into service after 9 December 2026, and the old Directive continues for products placed on the market or put into service before it (Articles 2(1) and 21). A product line with a long production run will sit under both regimes for a while, just as it does with the EU Machinery Regulation.
Member States must bring their implementing laws into force by 9 December 2026 (Article 22(1)). The Directive leaves little room to diverge: Article 3 bars national provisions that are more or less stringent. The liable parties include the manufacturer, a component manufacturer, and, for a product made outside the Union, the importer, the authorized representative, or a fulfilment service provider (Article 8).
Article 7
How Instructions Enter the Test
A product is defective where it does not provide the safety a person is entitled to expect or that is required under Union or national law (Article 7(1)). Article 7(2) then says all circumstances are taken into account, including these.
- Presentation and instructions: Article 7(2)(a)
- The presentation and characteristics of the product, including labeling, design, technical features, composition and packaging, and the instructions for its assembly, installation, use and maintenance.
- Foreseeable use: Article 7(2)(b)
- Reasonably foreseeable use of the product, which is wider than the use the manual describes.
- Time of placing on the market: Article 7(2)(e)
- The moment the product was placed on the market or put into service or, where the manufacturer keeps control, the moment it left the manufacturer's control.
- Safety requirements: Article 7(2)(f)
- Relevant product safety requirements, including safety-relevant cybersecurity requirements.
- The users it is for: Article 7(2)(h)
- The specific needs of the group of users for whose use the product is intended.
The instructions are one factor among several, so a good manual does not make an unsafe product safe, and a flawed one does not decide the case alone. What the text does is put what you told the user, and when, on the list of things a court weighs. Warnings that are clear, specific, and findable matter more for it; our guide to warnings, cautions, and notes covers how to write them.
Articles 9 and 10
Evidence a Defendant May Be Asked For
Article 9(1) lets a court order a defendant to disclose relevant evidence at its disposal when the claimant has presented facts and evidence sufficient to make the claim plausible. Disclosure is limited to what is necessary and proportionate, and courts must weigh trade secrets and confidential information (Article 9(3) to (5)).
The consequence of not disclosing is in Article 10(2)(a): defectiveness is presumed. Article 10(2)(b) adds a second route: it is presumed where the claimant shows the product does not comply with mandatory product safety requirements that are meant to protect against the risk of the damage suffered. Any presumption can be rebutted (Article 10(5)). The claimant still has to prove the damage, the defect, and the causal link (Article 10(1)), subject to the presumptions.
The Directive does not itself oblige you to keep any particular record. The point is narrower: if a claim arrives, what you can produce shapes your position, and what you cannot produce may be held against you.
Records
What a Manual Team Can Be Ready to Show
- Which revision shipped with which unit
- The instructions in force when a product was placed on the market are the ones a court will look at first. A unit-to-revision link, by serial range or ship date, lets you show what the user actually received.
- What each revision said, and when it took effect
- Article 7(2)(e) makes the moment the product was placed on the market a factor. Effective dates on every revision, not just a revision letter, show which text applied when.
- Why each warning is worded as it is
- Who approved a warning, on what hazard analysis, and when. A warning with a recorded basis is easier to defend than one nobody can explain.
- What changed between revisions, and why
- A change history shows that a known problem produced a documented correction. It also shows what the earlier text said, which is what a claim about an older unit will turn on.
- Proof of how the manual reached the user
- Printed in the box, a download page, an in-product link. The format you used matters under rules such as those compared in our guide to EU digital manual rules.
Four existing practices carry most of this. Dating every revision by when it takes effect is covered in publishing documents that change on a date. Keeping a support branch for each shipped version is in branching for documents. Holding a product to the instructions it shipped with is pinning. How long the file must stay reachable online is a separate question under the rules compared in EU rules on digital manuals compared.
Exemptions
Defenses, and Why Dates Matter to Them
Article 11(1) lets an economic operator escape liability by proving particular facts. Three bear on documents. Under 11(1)(c), that it is probable the defect did not exist when the product was placed on the market, or came into being afterward; showing what the product and its instructions were at that moment takes dated records. Under 11(1)(d), that the defect is due to compliance with legal requirements. Under 11(1)(e), the development risk defense: the state of scientific and technical knowledge at the time was not such that the defect could be discovered.
Software is treated differently. Article 11(2) says the 11(1)(c) exemption does not apply to defects due to a related service, to software including updates or upgrades, to a lack of updates needed to maintain safety, or to a substantial modification, where these are within the manufacturer's control. For a connected product, the manual that explains updates, and the record of what each update changed, are therefore part of the picture. Claims can follow a product for years: the expiry period is 10 years, and 25 for latent personal injury (Article 17).
Next Steps
Where to Start
- Work out which products and production runs will be placed on the market after 9 December 2026.
- Check whether you can say, for any serial number, which manual revision shipped with it.
- Put an effective date on every revision, and record who approved each warning and why.
- Ask counsel which records your national law and your insurers expect you to keep, and for how long.
FAQ
Questions We Hear
When does the EU Product Liability Directive apply?
Directive (EU) 2024/2853 applies to products placed on the market or put into service after 9 December 2026 (Article 2(1)). Member States must bring in their implementing laws by the same date (Article 22(1)). The old Directive 85/374/EEC is repealed from 9 December 2026 but keeps applying to products placed on the market or put into service before that date (Article 21).
Does the Directive cover software?
Yes. Article 4(1) defines a product as all movables, including when integrated into or inter-connected with another movable or an immovable, and says it includes electricity, digital manufacturing files, raw materials and software. Article 2(2) excludes free and open-source software developed or supplied outside the course of a commercial activity.
Are instructions really part of the test for a defect?
They are one of the circumstances. A product is defective where it does not provide the safety a person is entitled to expect or that is required under Union or national law (Article 7(1)). In assessing that, all circumstances are taken into account, including the instructions for assembly, installation, use and maintenance (Article 7(2)(a)). The Directive does not say a manual error alone makes a product defective.
What does Article 9 mean for my documentation?
A claimant who presents sufficient facts and evidence can ask a national court to order the defendant to disclose relevant evidence at its disposal, limited to what is necessary and proportionate (Article 9(1) and (3)). If the defendant fails to disclose, defectiveness is presumed, and the defendant may rebut that (Article 10(2)(a) and (5)). Records such as manual revisions and approvals are the kind of material a court could ask for.
Is the development risk defense still available?
Article 11(1)(e) exempts an economic operator that proves the objective state of scientific and technical knowledge, when the product was placed on the market or while it was within the manufacturer's control, was not such that the defect could be discovered. Article 11(2) removes the exemption in Article 11(1)(c) for defects due to software, including updates, or to a lack of updates needed to maintain safety, where within the manufacturer's control.
How long can a claim be brought?
Compensation rights expire 10 years after the product was placed on the market or put into service, or after a substantial modification, unless proceedings have started (Article 17(1)). For latent personal injury the period is 25 years (Article 17(2)). That is the horizon for keeping the documentation behind a product.
Get In Touch
Know Which Manual Shipped With Which Unit
Tell us how your manuals are versioned and published today. We will show you where the gaps are between that and a record you could produce.