2028-08-02 · EU · 720 days from today
Manufacturers embedding AI as a safety component in products already subject to EU product-safety law must bring those systems into compliance with the AI Act's high-risk regime by August 2, 2028. Compliance flows through existing sectoral assessment pathways.
What it requires
If your product is subject to EU safety regulation — medical devices, machinery, toys, vehicles — and contains AI that affects safety, that AI system must satisfy the AI Act's high-risk requirements. You do not use a separate AI conformity process. Instead, you integrate AI compliance into your existing product conformity assessment under the relevant sectoral rule. The AI component must be documented, tested, and governed as part of your current product-safety compliance chain.
Who it binds
Manufacturers and distributors of medical devices, industrial machinery, toys, and vehicles that embed AI in safety-critical functions. Quality assurance, product compliance, and AI governance teams responsible for those product lines. Notified bodies and conformity assessment organizations that perform safety audits on these products.
How to check whether you comply
Identify which of your products fall under EU safety directives (Medical Device Regulation, Machinery Regulation, Toy Safety Directive, vehicle type-approval rules).
Map which embedded AI systems in those products affect safety or key performance characteristics.
Review your current sectoral conformity assessment procedure and confirm it covers AI component documentation, testing, and risk management.
Verify your quality management system can document AI lineage, training data, and performance validation alongside hardware and firmware.
What teams get wrong
This deadline was deferred from August 2, 2027. Do not assume your existing product conformity process automatically covers AI — you must explicitly integrate AI governance, testing, and documentation into your sectoral assessment. The requirement uses existing regulatory pathways, not a parallel AI-only approval.
This is one of 17 dated AI obligations we track
You have 720 days on this one. There are 16 others across the EU, UK, and US, and they do not arrive in a convenient order. The AI Compliance Deadline Radar lists every one of them with a live countdown.
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AI Act — Article 111(3), legacy GPAI models — EU, 2027-08-02
AI Act — Article 50 marking, systems already on the market — EU, 2026-12-02
Source
Not legal advice. This summarizes a public source so you can act on it; verify against the primary text before you rely on it.