Product liability
From 9 December 2026, the name on the product is the one that answers for it.
Directive (EU) 2024/2853: for products placed on the market after 8 December 2026
The revised Product Liability Directive treats software as a product, and treats a party that puts its own name, trade mark or other distinguishing feature on a product as its manufacturer. If you sell an AI voice agent to dental or healthcare clients under your own brand, that is you — even though you did not build the underlying technology. In personal-injury cases the claimant may not have to prove you were careless, which turns everything on one question: can you show what the AI released?
What the directive says
- Software is a product for the purposes of the liability regime.
- Directive (EU) 2024/2853, Art. 4(1)
- A party that puts its name, trade mark or other distinguishing feature on a product is liable as its manufacturer.
- Directive (EU) 2024/2853, Art. 8(1)(b)
- The regime applies to products placed on the market after 8 December 2026; deployments already on the market are not caught. It is a directive, so transposition and the exact national wording run per member state.
- Directive (EU) 2024/2853, Art. 22
- Separately, a person interacting with an AI system must be informed of that, unless it is obvious from the circumstances.
- Regulation (EU) 2024/1689, Art. 50(1), has applied since 2 August 2026
What a per-call record gives you
- A contemporaneous record of every governed call: the approved disclosure text and when its audio finished being sent, the policy version in force, and the decision — with the input and the output stored as hashes rather than words.
- The evidence record for the call holds the approved disclosure text, its language, and the moment its audio finished being sent. It does not record that the caller heard or understood it.
- Scope-of-practice and brand-governance checks recorded per interaction, so the boundary the agent stayed inside is on the record too.
- Export in open formats, to hand to your client, your insurer or your own counsel. Retested after the deploy on 26 August on browser calls: five calls, thirty validated turns, thirty receipts.
The shift
Three sentences, and the middle one is the expensive part.
- The revised directive extends Europe's strict, no-fault liability regime to software and AI systems, and applies from 9 December 2026.
- A party that puts its own name on a product is treated as its manufacturer, regardless of who built the technology underneath.
- In personal-injury verticals the claimant may not have to prove carelessness. What is left to argue about is what actually happened, and that is a documentation question rather than an intent question.
Scope
Where this bites hardest.
This page is written for the case where you sell an AI voice agent under your own brand to dental or healthcare clients, and where a defective interaction can plausibly contribute to personal harm. In other verticals the personal-injury logic works differently, and the exposure has a different shape.
Audact does not remove, limit or cap your liability, and it is not a guarantee of any outcome. What it gives you is the contemporaneous record: the documentation that lets you show you acted responsibly, if you are ever asked to.
General information, not legal advice. Talk to your own counsel about how the directive applies to you and to your clients.
Timing
The record can only be made while the call is happening.
That is the whole argument for doing this before the date rather than after it. A transcript reconstructed later is a reconstruction; a receipt written at the moment of the call, chained to the one before it, is a record. The fourth, inclusion in the Merkle root, is checked against the published root with the inclusion proof from the call's Article 50 report, and production export worked when it was retested on 26 August 2026 after the deploy, measured on browser calls rather than over a telephone line. What the receipt already carries is the other three: the input hash, the output hash and the link to the receipt before it — each of them recomputable without a key.
Questions
- Does this apply to me if I only white-label?
- White-labelling is exactly the trigger. Article 8(1)(b) turns on whose name, trade mark or distinguishing feature is on the product, not on who wrote the code. Whether your specific arrangement falls inside it is a question for your own counsel, and it is worth asking before December rather than after.
- Is Audact taking on the liability instead of me?
- No, and any vendor telling you otherwise is selling you something they cannot deliver. What we provide is the record you use to show you acted responsibly. Where our governance engine lets through an utterance it should have blocked under the active rules, you get the evidence file to answer with, and any financial compensation your signed order form provides. Not insurance, and not cover for third-party claims.
- It is a directive, not a regulation. Does that change anything?
- Yes, in the detail. A directive is transposed into national law, so the exact wording, the thresholds and the procedure differ per member state. The 9 December 2026 date and the structure above are common; the specifics for your country are worth checking with local counsel, particularly if you serve clients in more than one.
Have the record before December
We configure the first agent, the disclosure wording and the evidence chain with you, so the documentation exists from the first call rather than from the first complaint.
Related
The 9 December 2026 deadline For agencies Price, margin and who carries the risk.
EU AI Act All comparisons Dental Healthcare
