EU Product Liability Directive · in force 9 December 2026
From 9 December 2026, if you put your brand on the AI you sell to dental or healthcare clients, EU law can treat you as the manufacturer.
The revised EU Product Liability Directive (2024/2853) reaches software and AI. If you put your own brand on an AI voice agent and sell it to dental or healthcare clients, EU law can treat you as the manufacturer — and carry strict (no-fault) responsibility for defects that cause harm. You are the one who has to be ready. Audact’s per-call evidence helps you show you acted responsibly.
General information, not legal advice.
This page explains the Product Liability Directive in plain terms so you can have an informed conversation. It is not legal advice and does not describe your specific obligations. Talk to your own counsel about how PLD applies to you and your clients.
The shift
The revised EU Product Liability Directive (2024/2853) applies from 9 December 2026. It modernises Europe’s strict (no-fault) liability regime and extends it to software and AI systems. If you put your own brand on the AI you sell, EU law can treat you as the manufacturer of that product — even though you didn’t build the underlying technology.
What it means for you
If you put your brand on an AI voice agent you sell to dental or healthcare clients, from 9 December 2026 you may carry manufacturer-style responsibilities for what that AI does. In personal-injury verticals, the claimant may not have to prove you were careless — which makes one question central: can you show what the AI actually said and did?
How Audact helps
Audact records a per-call, tamper-evident evidence chain of exactly what the AI did and did not say. That contemporaneous record is the kind of documentation an agency can use to show it acted responsibly and exercised due diligence — that disclosures were made, the approved script was followed, and the agent stayed within scope.
What a per-call evidence record gives a dental or healthcare agency
Audact does not remove, limit, or cap your liability, and it is not a guarantee of any outcome. What it gives you is a contemporaneous record — the documentation that helps you demonstrate you acted responsibly if you are ever asked.
- A signed, tamper-evident record of every call — what was said, when, by which agent.
- Evidence the required AI disclosure was made and the approved script was followed.
- Scope-of-practice and brand-governance checks recorded per interaction.
- Audit-ready exports you can hand to your client, your insurer, or your counsel.
Audact’s evidence-chain technology is patent-pending (UK IPO). Tirza is Audact’s own EU reference deployment.
You are the hero here
The branded provider is the one regulators and claimants look to. Your job is to be ready: documented disclosures, an approved script, and a record of every call. Audact produces that record so the responsibility you carry is one you can evidence.
Scoped to personal-injury verticals
This applies specifically to dental and healthcare clients where you sell the AI under your own brand, and where a defective interaction can plausibly contribute to personal harm. For other verticals, the personal-injury logic differs — ask your counsel about your own exposure.
Be ready before 9 December 2026.
If you put your brand on the AI you sell to dental or healthcare clients, we’ll set up your first agent, the disclosures and the evidence chain with you — so you have a contemporaneous record to stand behind. EU-hosted in Frankfurt. A signed receipt for every call.
General information, not legal advice. Talk to your own counsel about how the Product Liability Directive applies to you.