Machinery is covered by Regulation (EU) 2023/1230, which Regulation (EU) 2026/1744 moved to Section B of Annex I. An AI system that is a safety component of machinery, or is itself machinery, can be high risk under Article 6(1) where third party conformity assessment is required under the Machinery Regulation. The AI requirements are then to be integrated into the machinery regime, with delegated acts amending Annex III to Regulation (EU) 2023/1230 to reflect the relevant AI Act requirements. The Machinery Regulation has its own application and transition rules, which must be checked alongside the AI Act date of 2 August 2028.
What counts as machinery for this guide?
Regulation (EU) 2023/1230 on machinery covers machinery, related products and partly completed machinery, with scope and exclusions set out in its own provisions. It replaced Directive 2006/42/EC, subject to transitional provisions in the Machinery Regulation itself. This guide uses machinery in that sector sense, not in the loose sense of any machine or any industrial equipment. A product that looks like machinery in ordinary language may fall outside the Machinery Regulation, or may fall under a different Annex I instrument, and a product inside the Machinery Regulation may also be covered by other legislation. The first record for a machinery product should therefore cite the Machinery Regulation scope provision relied on and note any exclusion considered. The AI Act analysis then builds on that sector conclusion. If the sector conclusion is wrong, the AI Act conclusion built on it will also be wrong. That dependence is why the sector text should be read first and why a general AI guide cannot substitute for the machinery file.
When is an AI function a safety component of machinery?
Article 3 defines a safety component as a component of a product or of a system which fulfils a safety function for that product or system, or the failure or malfunctioning of which endangers the health and safety of persons or property. For machinery, the question is functional. A vision system that stops a press when a hand enters a danger zone performs a safety function in a direct way. A vision system that counts finished parts for production statistics may not, even if it uses similar technology. A system that optimises speed or energy use can become safety relevant if its failure can endanger persons or property, for example by allowing unsafe speed or by disabling a protective measure. The intended purpose stated by the provider matters, but it is not conclusive on its own. Instructions, promotional material, configuration options and reasonably foreseeable use all form part of the picture. The record should describe the function, the hazard it addresses or creates, the failure consequence and the evidence, such as a risk assessment, that supports the conclusion. Where the function is borderline, the record should mark it as borderline and seek confirmation rather than recording a confident answer that the evidence does not support.
For the broader regulatory framework, see products, machinery and vehicles overview.
How does Section B change the work for machinery?
Because machinery now sits in Section B, Article 2(2) limits the AI Act provisions that apply directly to the provisions it names, and Articles 57 to 59 on sandboxes apply only so far as the high risk requirements have been integrated into the Machinery Regulation. Regulation (EU) 2026/1744 requires the Commission to adopt delegated acts amending Annex III to Regulation (EU) 2023/1230 so that the essential health and safety requirements reflect the relevant requirements in Chapter III, Section 2 and Articles 17, 19, 72 and 73 of the AI Act. Until those delegated acts and any related sector measures are in place and checked, a machinery manufacturer cannot complete the AI picture from the AI Act alone. The manufacturer must track the Machinery Regulation amendments, the harmonised standards for machinery, and the AI Act standards work in parallel. The conformity file should cite the sector provisions relied on and should be updated when a delegated act changes the essential requirements. A file that cites only the AI Act for a machinery product will be incomplete under the Section B architecture, and a file that cites only the Machinery Regulation without addressing the AI integration will also be incomplete.
What about machinery used in a workplace?
Machinery in a workplace brings a second layer of rules that this guide does not replace. Workplace safety duties, employer duties and national implementation of workplace directives operate alongside product rules, and the deployer of machinery in a workplace has duties that are distinct from the duties of the machinery manufacturer. The AI Act deployer provisions and the product manufacturer provisions must not be confused. A factory that buys machinery with an AI safety function is a deployer for AI Act purposes in relation to its use of the system, and it also has workplace duties in relation to its workers. A manufacturer that supplies the machinery is the product manufacturer and may be treated as the provider of a high risk system under Article 25(3) in the Section A context, but for Section B machinery the sector route governs the detail and must be checked. The workplace guide in this cluster deals with the deployer side in more detail. For the present guide, the point is that a single machine can attract product, AI Act and workplace analysis at the same time, and the records for each analysis should be kept distinct even when they draw on the same risk assessment.
What evidence should a machinery file hold?
A machinery file should hold the product identification, the Machinery Regulation scope reasoning, the safety component analysis for each AI function, the risk assessment, the essential health and safety requirements addressed, the harmonised standards or other technical solutions applied, the conformity assessment procedure followed, test and validation evidence, instructions for use, and the declaration of conformity. For AI functions, the file should also hold data governance information, logging and human oversight arrangements, accuracy and robustness evidence and post market monitoring plans to the extent that the integrated sector requirements call for them. The file should distinguish between evidence that shows a function works under test conditions and evidence that shows it works safely in the intended workplace conditions, including foreseeable misuse. Changes to software, models, sensors or safety logic after placing on the market should be logged, with a fresh assessment of whether the change is a substantial modification. The file is a working record, not a marketing document, and gaps in it should be visible rather than smoothed over.
Continue with Annex I Section A and Section B.
What does this guide leave open?
This guide does not decide whether any named machine or safety function is high risk, does not reproduce the essential health and safety requirements of the Machinery Regulation, and does not predict the content or timing of the delegated acts amending its Annex III. It does not state the application date of the Machinery Regulation, which must be checked in that Regulation itself, and it does not replace workplace safety advice. A manufacturer or deployer with a specific machine should confirm the current consolidated Annex I, the current Machinery Regulation, the delegated acts in force and the applicable harmonised standards with a competent authority or legal adviser, and should not place a machine on the market on the basis of this general guide alone.
Frequently asked questions
Is an AI vision system on a machine always a safety component?
No. The test in Article 3 turns on whether the component fulfils a safety function or whether its failure or malfunction endangers health and safety. A counting or quality vision system may not meet that test, while a guarding or stopping vision system may. The function, the hazard and the failure consequence must be assessed for the specific system, and the reasoning should be recorded with the risk assessment.
Does the AI Act apply directly in full to machinery?
Not after Regulation (EU) 2026/1744. Machinery is in Section B of Annex I, so Article 2(2) limits direct application to the provisions it names, and the substantive AI requirements are to be integrated into the Machinery Regulation through delegated acts. The machinery file must therefore track the sector integration, not only the AI Act chapter on high risk requirements.
What is the relevant AI Act date for machinery?
The Chapter III high risk rules for Annex I systems apply from 2 August 2028 under Article 113 as amended. That date does not replace the Machinery Regulation timetable, which has its own application and transition provisions. Both timetables must be checked, and the earlier of the applicable sector duties may bite first for a particular product.
Who is responsible when machinery is used at work?
Responsibility is split. The manufacturer carries product duties, the AI Act roles of provider and deployer are distinct, and the employer carries workplace duties. The same machine can therefore be examined under product law, the AI Act and workplace law at the same time. Records should keep those analyses distinct, and specific questions should be confirmed with a competent authority or legal adviser.
Continue through this AI Act cluster
This article is an informational overview, not a legal determination. Check the current legal text and official implementation guidance for your system and role.
Consolidated Regulation (EU) 2024/1689 ↗AI Act Service Desk timeline ↗