From 9 December 2026, the instructions are part of the product.
The revised Product Liability Directive applies to products placed on the market after that date. Inadequate instructions can render a product defective, that liability cannot be limited by contract, and the documents behind it can be ordered into disclosure.
Four shiftsDirective (EU) 2024/2853
What changes, in the terms that matter to a risk carrier.
Software is a product
Software and AI systems fall within the definition, which brings the machinery that runs them, and the instructions that describe them, into the same frame.
Liability cannot be contracted away
It cannot be excluded or limited by agreement. Supply terms that used to carry the exposure no longer do.
Disclosure in proceedings
A defendant can be ordered to disclose evidence. Documentation written for internal comfort is written for an opponent.
Wider routes to claim
Expanded liability alongside collective redress raises the expected volume of claims, not only their size.
Why instructionsthe exposed surface
The manual is the part of the product a claimant can read.
A design defect requires expert evidence to establish. A missing warning, a contradictory setting value or a maintenance interval stated two ways requires the document and a highlighter. It is the cheapest defect to plead and the hardest to explain away, because the manufacturer wrote it, issued it and controlled it.
The document set is also the only part of the product that can still be corrected after the machine has shipped.
Who holds itnot only the maker
The obligation moves further down the chain than most parties assume.
- Importers and distributors can carry manufacturer-level obligations at the point of placing a product on the market.
- Authorised representatives carry duties for principals outside the Union, frequently with no documentation function of their own.
- Refurbishers, retrofitters and integrators who substantially modify machinery can inherit the manufacturer obligation, usually holding no technical file at all.
- Insurers of any of the above hold the financial consequence of a document nobody in the chain has assessed.
Establishing which party carries the obligation for a given product is the first page of an assessment, and it is regularly the finding the client did not expect.
Sequencetwo dates, one exercise
December and January are the same piece of work.
Product liability applies from 9 December 2026. The Machinery Regulation applies from 20 January 2027 and sets out what instructions for use must contain. Assessing a set against the second is what produces the evidence for the first.
This page describes documentation exposure arising under Directive (EU) 2024/2853 and is provided for information. It is not legal advice, not a conformity assessment and not certification. Liability, scope and interpretation remain matters for the party carrying the obligation and its legal advisers.
Send one product family. We will tell you what sits between the documents.
A non-disclosure agreement is in place before any technical material is received.
- The manufacturer and the product family involved
- Which documents exist, and which are referred to but not held
- Whether this is pre-bind, renewal, a risk improvement condition, or a claim
- Your timescale