AI in machinery: the AI Act and the Machinery Regulation after the Omnibus
A manufacturer embeds a machine-learning safety component in machinery covered by Regulation (EU) 2023/1230. Regulation (EU) 2026/1744 moved that Regulation into Annex I Section B of the Act, as recorded in the regulation data In force. For a Section B product, Art. 2(2) applies only Art. 6(1), Art. 60a and Art. 102 to 112; the AI requirements reach the machine through the Machinery Regulation and delegated acts. This page gives the classification, the test content taken from Art. 9 and Art. 15 as reference, the sequence, and the evidence the machinery technical file holds.
Where this starts
The manufacturer already keeps a technical file under Annex IV Part A of Regulation (EU) 2023/1230, a risk assessment under Annex III Part B of that Regulation, and a notified body relationship under its Art. 25(2). The regulation entry for machinery records what Regulation (EU) 2026/1744 changed: "Deleted Annex I Section A point 1 (Directive 2006/42/EC on machinery) and added Regulation (EU) 2023/1230 as Annex I Section B point 21. The Omnibus also amends Regulation (EU) 2023/1230 itself, with delegated acts on AI-specific requirements due by the Annex I application date." Amended Art. 2(2) then reads: "For AI systems classified as high-risk AI systems in accordance with Article 6(1) related to products covered by the Union harmonisation legislation listed in Section B of Annex I, only Article 6(1), Article 60a and Articles 102 to 112 shall apply. Articles 57, 58 and 59 shall apply only in so far as the requirements for high-risk AI systems under this Regulation have been integrated in that Union harmonisation legislation." The list now includes Art. 60a, the new article on testing Section B high-risk systems in real-world conditions outside a sandbox, and Art. 110 and 111 alongside the sectoral amendments of Art. 102 to 109 and the review clause of Art. 112; the sandbox articles Art. 57 to 59 apply only where the high-risk requirements have been integrated into the Machinery Regulation. Chapter III Section 2, the provider duties of Art. 16, the conformity assessment of Art. 43 and the market surveillance procedure of Art. 79 do not apply to the safety component through the Act. The requirements are taken into account through the sectoral act: the regulation entry records delegated acts on AI-specific requirements under the Machinery Regulation, due by the Annex I application date Deferred. Until those acts apply, the requirements the notified body assesses are the essential health and safety requirements of Annex III as they stand. The Machinery Regulation carries its own application date in its Art. 54 and repeals Directive 2006/42/EC; the transition between the two machinery texts is a question for the manufacturer's counsel, and the Annex I manufacturer hub carries the obligation set with its dates.
Art. 6(1) still applies, and it decides whether the machine enters this scenario at all. A system is high-risk under Art. 6(1) when it is a safety component of a product covered by an Annex I law, or is itself such a product, and the product or the component undergoes third-party conformity assessment under that law. Annex I Part A of the Machinery Regulation lists, at points 5 and 6, "safety components with fully or partially self-evolving behaviour using machine learning approaches ensuring safety functions" and machinery that embeds such systems; Art. 25(2) of that Regulation sends Part A categories through EU type-examination with conformity to type, full quality assurance or unit verification, each with a notified body. A learned model that ensures a safety function, such as person detection that stops a movement, therefore meets both conditions of Art. 6(1). A learned model that does not ensure a safety function, such as scheduling or wear prediction, is not a safety component under Art. 3(3) of the Machinery Regulation and does not enter Art. 6(1) by that route; recital 55 of the Machinery Regulation confines the third-party provisions to self-evolving systems and excludes software that only executes programmed functions. The risk classifier runs the Art. 6(1) route on the published logic and records the Section B scope note.
What is tested is set by the Machinery Regulation, and its Annex III already states the outcomes a learned safety control system has to show. Point 1.2.1 requires that the control system withstands intended and unintended external influences "including reasonably foreseeable malicious attempts from third parties", that a fault in the hardware or the logic and an error in the logic do not lead to a hazardous situation, that the limits of the safety functions come from the risk assessment, and that no modification to the settings or rules generated by the machine, "including during the machinery or related product learning phase", is allowed where it could lead to a hazardous situation. For self-evolving control systems the same point requires that the machine does not act beyond its defined task and movement space, that data on the safety-related decision-making process is recorded and retained for one year, and that the machine can be corrected at all times; point 1.1.9 requires protection against corruption of the components that carry safety-critical software. The obligation records for Art. 9 and Art. 15 hold the same ground in testable form: consistent performance across the recorded operating conditions and testing against prior defined metrics and probabilistic thresholds under Art. 9(6) and 9(8), resilience to errors, faults and inconsistencies under Art. 15(4), and resistance to the attack classes of Art. 15(5). Neither Regulation gives a numeric threshold: Art. 15 sets none, and the Annex III requirements are stated as outcomes. Art. 20(1) of the Machinery Regulation attaches a presumption of conformity to a harmonised standard cited in the Official Journal for the requirement it covers, and no harmonised standard for the AI Act is cited in the Official Journal as of the anchor date. The metric categories and perturbation classes in use come from the JTC 21 draft prEN 18229-2Draft, the assessment methods from the published ISO/IEC TR 24029-1:2021Published, and the threat list behind Art. 15(5) from prEN 18282Enquiry at enquiry stage. The manufacturer sets each target in the product's own performance terms, justifies it against the intended use and records the justification before any run.
The sequence
The work runs in the order below: classification first, then the obligation register, then the metrics, then the tests, then the file and its re-test triggers.
Check whether each learned function ensures a safety function and enters an Art. 25(2) third-party procedure.
Record High-risk classification record per function, with the Art. 2(2) scope note
[Regulation (EU) 2024/1689, Art. 6(1)(a) and (b); Regulation (EU) 2023/1230, Annex I Part A points 5 and 6 and Art. 25(2); PR-CLS step 12]
Compile the obligation register: Annex III requirements as the assessed set, Art. 9 and Art. 15 as reference.
Record Obligation register: Art. 6(1) under the Act, Annex III essential requirements under the Machinery Regulation, with the machinery regulation entry id
[Regulation (EU) 2024/1689, Art. 2(2); PR-CLS steps 38 to 40]
Extract each hazard, the limits of each safety function and the misuse conditions from the risk assessment.
Record Hazard register with the limits of each safety function and the misuse conditions (Art. 9(2)(a) and (b))
[Regulation (EU) 2023/1230, Annex III Part B general principle 1 and point 1.2.1(d); Regulation (EU) 2024/1689, Art. 9(2)(a) and (b); PR-15-ROB steps 4 to 5]
Define each metric in the product's performance terms, with its threshold and the justification against the intended use.
Record Prior defined metrics and probabilistic thresholds declaration (Art. 9(8))
[Regulation (EU) 2024/1689, Art. 9(8); prEN 18229-2, draft, accuracy metric declaration; PR-15-ROB steps 8 to 9]
Run the held-out, shifted, perturbation and fault-injection sets on the frozen version of the safety component.
Record Robustness test report with perturbation, fault-injection and fail-safe results (PR-15-ROB output)
[Regulation (EU) 2023/1230, Annex III point 1.2.1(b) and (c); Regulation (EU) 2024/1689, Art. 15(1) and 15(4); PR-15-ROB steps 14 to 20]
Run each Art. 15(5) attack class against the safety component; record detection, response, resolution and control.
Record Adversarial and cybersecurity test report covering the Art. 15(5) attack list (PR-15-ROB output)
[Regulation (EU) 2023/1230, Annex III points 1.1.9 and 1.2.1(a); Regulation (EU) 2024/1689, Art. 15(5); PR-15-ROB steps 11 and 23 to 30]
Run each hazard scenario and misuse condition; record whether the machine stays within its defined task and movement space.
Record Risk-driven test report per hazard, condition and safety-function limit (PR-15-ROB output)
[Regulation (EU) 2023/1230, Annex III point 1.2.1, self-evolving control systems, points (a) to (c); Regulation (EU) 2024/1689, Art. 9(6); PR-15-ROB steps 16 and 21]
Place each report in the technical documentation and trace each essential requirement to its test result.
Record AI annex to the machinery technical documentation with the traceability matrix from each essential requirement to its evidence
[Regulation (EU) 2023/1230, Annex IV Part A points (b), (f) and (g); PR-11-DOC steps 14, 18 and 43]
Record the re-test triggers for each model, data and configuration change and the version log of the safety software.
Record Lifecycle performance monitoring record with re-test triggers and the safety software version log
[Regulation (EU) 2023/1230, Art. 3(16), Art. 18 and Annex III point 1.2.1(f); Regulation (EU) 2024/1689, Art. 15(1); PR-15-ROB step 45]
Evidence this situation ends with
| Artifact | Answers | Produced by |
|---|---|---|
| High-risk classification record with the Art. 2(2) scope note | Art. 6(1)(a) and (b): the function ensures a safety function and enters a third-party procedure under Art. 25(2) of the Machinery Regulation | PR-CLS v1.0 |
| Prior defined metrics and probabilistic thresholds declaration (Art. 9(8)) | Art. 9(8) and Annex III point 1.2.1(d) of the Machinery Regulation: each metric, threshold and safety-function limit recorded before the run, with its justification | the manufacturer |
| Robustness test report with perturbation, fault-injection and fail-safe results (PR-15-ROB output) | Art. 15(4) and Annex III point 1.2.1(b) and (c) of the Machinery Regulation: a fault or an error in the control logic does not lead to a hazardous situation | PR-15-ROB v1.0 |
| Adversarial and cybersecurity test report covering the Art. 15(5) attack list (PR-15-ROB output) | Art. 15(5) and Annex III points 1.1.9 and 1.2.1(a) of the Machinery Regulation: resistance to malicious attempts from third parties, with the threat model | PR-15-ROB v1.0 |
| Risk-driven test report (PR-15-ROB output) | Art. 9(6) and 9(8) and Annex III Part B general principle 1 of the Machinery Regulation: each hazard, misuse condition and safety-function limit tested against its threshold | PR-15-ROB v1.0 |
| Residual risk acceptance record per hazard and overall (Art. 9(5)) | Art. 9(5) and Annex IV Part A point (b)(ii) of the Machinery Regulation: the residual risk per hazard after the protective measures, against the recorded criterion | the manufacturer |
| Traceability matrix from each essential health and safety requirement to its evidence | Annex IV Part A points (b)(i) and (g) of the Machinery Regulation: each applicable requirement listed and tied to a dated test report | PR-11-DOC v1.0 |
| Lifecycle performance monitoring record with re-test triggers | Art. 15(1) and Annex III point 1.2.1(f) of the Machinery Regulation: the safety software version log and the change that invalidates each report | PR-15-ROB v1.0 |
Each artifact follows a specification with a synthetic sample on the deliverables page: the test reports follow the test report specification, the matrix follows the traceability matrix specification, and the classification record follows the assessment memo specification.
If nothing is done
For a Section B product the consequence does not run through the Act: Art. 2(2) leaves Art. 79 market surveillance measures and Art. 99 penalties outside the articles that apply to the safety component. The consequence runs through Regulation (EU) 2023/1230. Under Art. 43(1) of that Regulation, a market surveillance authority with sufficient reason to believe that a machine presents a risk evaluates it against all relevant requirements, and where it finds non-compliance it requires the manufacturer to take corrective action under Art. 16(3) of Regulation (EU) 2019/1020, to end the non-compliance or eliminate the hazard within a period commensurate with the risk, and informs the notified body. Art. 46 covers formal non-compliance, and Art. 50 leaves the penalty rules to each Member State. The manufacturer's own action sits in Art. 10(9) of the Machinery Regulation: on reason to believe that the machine does not conform, it takes the corrective action, withdraws or recalls the machine, and informs the competent national authorities where the machine presents a risk. The sequence above produces the test reports and the risk assessment documentation that Annex IV Part A points (b) and (g) require in the technical file, and the source code or programming logic that Art. 10(3) requires the manufacturer to make available on a reasoned request.
Services, guides and tools for this situation
The robustness and adversarial testing service runs the Art. 15 and Annex III tests under PR-15-ROB v1.0, within the limits stated on what we cannot do; the technical documentation service places the reports in the machinery technical documentation and builds the traceability matrix under PR-11-DOC v1.0. The notified body assessment under Art. 25 of the Machinery Regulation, the EU declaration of conformity and the CE marking remain with the manufacturer and its notified body.
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Questions
Does the EU AI Act apply to AI in machinery?
The Act applies to AI in machinery in a limited way. After Regulation (EU) 2026/1744, Regulation (EU) 2023/1230 on machinery sits in Annex I Section B of the Act. A learned safety component is high-risk under Art. 6(1), because Annex I Part A points 5 and 6 of the Machinery Regulation send it through a notified body under Art. 25(2). Art. 2(2) then applies only Art. 6(1), Art. 60a and Art. 102 to 112. The AI requirements are assessed through Annex III of the Machinery Regulation and delegated acts.
Every inquiry receives a reply within 24 hours. Scope and availability are discussed per request.