The Digital Omnibus narrows the definition that decides whether AI embedded in a regulated product counts as high-risk under the EU AI Act (Regulation (EU) 2024/1689). AI used solely for user assistance, performance optimisation, service efficiency or automation, or convenience or quality control no longer makes a component a “safety component” — and doesn’t trigger high-risk classification by virtue of sitting inside a regulated product — unless its failure or malfunction would actually endanger health or safety. Separately, the Machinery Regulation moved out of Annex I Section A into Section B entirely, so AI-enabled machinery now complies with sectoral safety rules instead of both regimes at once. Every guide written before May 2026 is describing a test that no longer applies.
The old test and why it swept too wide
Article 6(1) classifies an AI system as high-risk when two conditions are both met: it’s intended for use as a safety component of a product, or is itself a product, covered by the Annex I Union harmonisation legislation; and that product requires third-party conformity assessment under that legislation before it can be placed on the market. Whether an AI function counts as a “safety component” in the first place decides whether this whole test even applies.
The original definition of safety component covers a component that fulfils a safety function for a product or AI system, or whose failure or malfunction endangers the health and safety of persons or property. That second limb is where the trouble sits. Read expansively, almost any function embedded in a regulated product can be argued into it — an optimisation model inside a lift or a boiler doesn’t itself perform a safety function, but a sufficiently loose reading of “failure… endangers health and safety” could sweep it in anyway, on the theory that anything going wrong inside safety-regulated machinery carries some attenuated safety implication.
What the new test asks
The narrowed definition collapses this to one question: could the component’s failure or malfunction actually endanger health or safety? If the answer is no, and the function is assistance, optimisation, efficiency, automation, convenience, or quality control, it isn’t a safety component — regardless of what product it happens to sit inside.
Two examples on either side of the line. A predictive-maintenance model that flags when industrial machinery needs servicing is squarely an optimisation function: if it fails, the direct consequence is a missed maintenance window, not an immediate safety event, so it’s a strong candidate for falling outside the safety-component definition under the new test. A torque-limiting or collision-avoidance function built into the same machinery is a different case entirely — its failure directly creates a safety risk, which is exactly what the carve-out was never meant to exempt. The label attached to a function matters far less than what actually happens when it fails.
Annex I Section A vs Section B
This distinction decides how much of the Act applies at all. Section A covers New Legislative Framework legislation — medical devices, toys, personal protective equipment, gas appliances, and, until this reform, machinery. Section B covers other Union harmonisation legislation, including aviation security, agricultural and forestry vehicles, motor vehicle type-approval, marine equipment, and rail interoperability. For systems in Section B, only Article 6(1) itself, Articles 102 to 109, and Article 112 apply — essentially none of the Act’s substantive high-risk apparatus, the conformity assessment procedures, or the registration duties reach them at all.
The Omnibus moved only the Machinery Regulation from Section A to Section B. That’s a narrower outcome than what was actually on the table during trilogue: the deadlock that briefly collapsed negotiations centred on a Parliament proposal to exclude far more broadly — medical devices, toys, connected cars, and industrial machinery all together. The final compromise pulled back to Machinery alone. It isn’t a deregulation of industrial AI, either — the Commission is empowered to adopt delegated acts under the Machinery Regulation itself, not the AI Act, adding AI-specific health and safety requirements for systems that would otherwise have been high-risk. Oversight doesn’t disappear; it moves into the sectoral regime.
The other overlap relief, and its condition
Products that stayed in Section A — medical devices and toys among them — get a different, conditional form of relief instead of a full carve-out. Where the sectoral legislation already contains AI-specific requirements equivalent to or higher than the AI Act’s own, the Commission may, by implementing act, limit how far Articles 9 to 15 and 17 to 25 actually apply to those systems. That’s a genuinely different legal instrument from the Machinery-specific delegated acts, and it comes with its own timing: implementing acts addressing this general sectoral overlap are expected by 2 August 2027, while the Machinery-specific delegated acts are expected by 2 August 2028, tied to when Annex I obligations actually start binding. Both dates are worth putting on a calendar. Neither is a rule you can rely on today — nothing is actually limited until the Commission acts.
When any of this binds
Annex I high-risk obligations now apply from 2 August 2028 rather than 2 August 2027, under the same Digital Omnibus reform that deferred Annex III obligations to 2 December 2027. As with every date in this reform, it binds only once the amending regulation is published in the Official Journal and enters into force — as of this writing, formal adoption and publication were still pending, with the original 2 August 2026/2027 calendar remaining the legally operative one until that happens.
Frequently asked questions
Is a predictive maintenance model a safety component?
Generally not, under the narrowed test — unless the specific machine’s failure mode makes a missed service interval itself a direct safety event rather than an efficiency loss. That’s genuinely fact-specific: the same category of model can land on either side depending on what actually happens when the maintenance flag is missed.
Does the Medical Devices Regulation change?
Not in the same way. Medical devices remain in Annex I Section A — they didn’t get the Machinery-style move to Section B. What they get instead is the conditional relief described above: if the Commission determines, by implementing act, that the sectoral legislation already imposes equivalent AI-specific requirements, application of the relevant AI Act articles can be limited. Until that happens, the full parallel regime still applies.
What about toys and lifts?
Both stay in Section A, on the same footing as medical devices — eligible for the conditional implementing-act relief if the Commission acts, but not moved to Section B the way Machinery was. Lifts in particular sit under their own directive, separate from the Machinery Regulation, and nothing in this reform touched that separately.
Does “quality control” cover visual inspection?
Often, but not automatically. A visual-inspection model that flags defective units for human review before they’re used is a strong fit for the quality-control carve-out — its failure means a defect goes unflagged, not an immediate safety event. But if that inspection is the only safeguard standing between a genuinely dangerous defective unit and its use, the “failure would endanger health or safety” test can still catch it. The function’s name doesn’t decide the answer; the actual consequence of it failing does.
Who decides — us or the notified body?
The provider makes the initial classification call, consistent with how Article 6 works generally — nobody else does it for you upfront. Where third-party conformity assessment still applies, a notified body’s scope determination matters downstream, but a market surveillance authority retains the ordinary power to review a provider’s classification later and require correction if it disagrees, the same oversight mechanism that applies to Article 6(3) classification calls elsewhere in the Act.