This is a hypothetical, illustrative example. The invented facts are: a manufacturer installs a vision system on a production line that inspects parts, rejects defective parts, and stops the line where a safety critical defect is found, using a camera, a model and a controller integrated with a machine. On those facts, the screening in this guide finds that the vision system is an AI system in scope, that the vision vendor and the machine manufacturer can each be a provider in different respects, that no Article 5 prohibition is shown, and that the Annex I route must be examined, including whether the vision function is a safety component of a machine covered by the Machinery Regulation, whether the machine is in Annex I Section B after the 2026 amendment, and whether the Article 2(13) and Article 60a provisions apply. The conclusion is provisional, tied to the invented facts, and must be confirmed with a competent authority or legal adviser for any real system. This example does not determine any real factory system.
What are the invented facts?
The invented facts are stated here so that the screening can be tested against them. A factory, Deployer F, operates a production line that makes metal parts for use in a consumer product. A vendor, Provider G, supplies a vision system, Vision H, that uses a camera, a model and a controller to inspect each part, to reject parts that do not meet a dimensional tolerance, and to stop the line where a part shows a crack that could cause the finished product to fail in use. Vision H is integrated with a machine on the line, Machine J, which is supplied by a machine manufacturer, Provider K, and which bears a CE mark under the Machinery Regulation. Vision H is installed after Machine J was placed on the market, as an upgrade, under a contract between Deployer F and Provider G. The vision system does not identify workers, does not infer emotions, and does not make decisions about workers. It inspects parts only, and the line stop is a safety function where a crack is found. Those facts are invented and simple, deliberately, so that the screening steps are visible. A real factory vision system will have more complex facts, including the safety analysis, the risk assessment, the integration design, the validation data, the human oversight, and the maintenance arrangements, each of which can change the screening.
How is scope and role screened?
Scope is screened first. Vision H is a machine based system that infers, from the input it receives, how to generate outputs such as inspection results, rejection signals and line stop commands, and it is designed to operate with varying levels of autonomy, with operators able to override the line stop. On the invented facts, it meets the Article 3(1) definition of an AI system, subject to the Commission guidelines on the definition being checked. It is placed on the Union market and put into service in the Union, so it is within Article 2. No exclusion applies on the invented facts. Role is screened next, and it is more complex than in the other examples, because several persons are involved. Provider G is a provider for Vision H, because it develops the vision system and places it on the market. Provider K is a provider for Machine J, as the machine manufacturer, and can become a provider for the AI system where Article 25(3) applies, where a product manufacturer places a high risk AI system on the market together with a product covered by Annex I Section A legislation under its own name or trademark. Deployer F is a deployer for Vision H, because it uses the system under its own authority for a professional activity, and can become a provider where it substantially modifies Vision H or Machine J, for example by changing the safety function, the thresholds or the integration in a way that amounts to a substantial modification. The role record must state each person, each product and each function separately, because a single label for the whole line will hide the provider and deployer duties that apply to different parts.
For the broader regulatory framework, see questions and misconceptions overview.
How is the prohibition screen done?
The prohibition screen lists each Article 5 prohibition and tests it against the invented facts. Manipulative and deceptive practices, exploitation of vulnerabilities, social scoring, untargeted scraping, emotion inference, biometric categorisation and remote biometric identification: none are shown, because Vision H inspects parts, not people, and does not use biometric or emotion data. The new December 2026 prohibitions on non consensual intimate material and child sexual abuse material are not shown, because Vision H does not generate or manipulate intimate or sexual content. That screen is provisional, tied to the invented facts, and must be redone if the vision system adds a worker monitoring function, such as detecting worker fatigue, attention or behaviour, which would raise the prohibition, Annex III employment and data protection questions completely differently. A vision system that inspects parts and a vision system that monitors workers are different systems for the Act, even where they use the same camera and the same model, and the prohibition screen must be done for each function separately. The record should state the functions screened, the data used for each, and the persons affected by each, so that a later addition of a worker function is visible as a new screen, not as a continuation of the parts screen.
How is the Annex I route screened?
The Annex I route is screened under Article 6(1), Annex I and Article 2. The first question is whether Vision H is intended to be used as a safety component of a product, or is itself a product, covered by Union harmonisation legislation listed in Annex I. Machine J is covered by Regulation (EU) 2023/1230 on machinery, which, after Regulation (EU) 2026/1744, is listed in Annex I Section B, not Section A, with the reference updated from Directive 2006/42/EC. For Section B products, Article 2(2) limits the direct application of the AI Act to Article 6(1), Article 60a and Articles 102 to 112, and Articles 57 to 59 apply only so far as requirements are integrated into sector law, with delegated acts to amend Machinery Regulation Annex III to reflect Chapter III Section 2 and Articles 17, 19, 72 and 73. The second question is whether Vision H fulfils a safety function for Machine J, such that its failure or malfunctioning endangers the health and safety of persons or property, within the Article 3 safety component definition. On the invented facts, Vision H stops the line where a crack is found, and a failure to stop the line could allow a defective part to reach a consumer product, so the safety component question must be examined with the machinery risk assessment, not assumed. The third question is whether the product must undergo third party conformity assessment under the sector legislation, which for machinery depends on the machine category and the Annex III procedure. The provisional position, tied to the invented facts, is that the Annex I Section B route must be worked through with the Machinery Regulation, the Article 2(2) limits, the Article 2(13) conditional limitation and the delegated acts due by 2 August 2027, and confirmed with a notified body or a competent authority. The high risk duties apply for Annex I product embedded systems from 2 August 2028, but the sector procedure and the delegated acts must be checked on the date of reliance.
What about substantial modification?
Substantial modification is a key question on the invented facts, because Vision H is installed after Machine J was placed on the market, as an upgrade. Article 3 defines a substantial modification as a change to an AI system after its placing on the market or putting into service which affects its compliance with the Chapter III Section 2 requirements or results in a modification to the intended purpose. Article 25 provides that a person who substantially modifies a high risk system becomes a provider for the modified system, and Article 43 provides for a new conformity assessment where a substantial modification occurs. On the invented facts, the installation of Vision H, the integration with Machine J, and the line stop function can amount to a substantial modification of Machine J, or to a new high risk system, depending on the safety analysis, the intended purpose and the effect on compliance. That question must be examined with the machine manufacturer, the vision vendor and a notified body, with the risk assessment, the integration design and the validation evidence recorded. Deployer F, Provider G and Provider K should agree, in writing, who is the provider for the modified system, who carries out the conformity assessment, who draws up the declaration, and who is responsible for post market monitoring. A modification that is treated as a minor upgrade, without a substantial modification analysis, will create a gap in the conformity file that will be difficult to close later.
Continue with machinery and safety components.
What does this example not decide?
This example does not decide whether any real vision system is a safety component, does not decide the Section B position for any named machine, and does not give a machinery conformity plan for any product. It is a hypothetical, illustrative walkthrough, built from invented facts, with a provisional Annex I analysis tied to those facts and a confirm with authority exit. A manufacturer, vendor or deployer with a real factory system should apply the screening order to its own facts, check the consolidated Regulation, the Machinery Regulation and the delegated acts, and confirm the classification, the conformity route and the substantial modification position with a notified body, a competent authority or a legal adviser. This example shows the method, not the answer for a real system.
Frequently asked questions
Is a quality inspection system always a safety component?
No. A safety component is a component that fulfils a safety function, such that its failure or malfunctioning endangers health and safety or property. A quality inspection system that rejects cosmetic defects is different from a system that stops a line to prevent a safety critical defect. The safety analysis and the risk assessment decide the question for each function.
Does machinery sit in Annex I Section A or Section B?
After Regulation (EU) 2026/1744, Regulation (EU) 2023/1230 on machinery is in Annex I Section B, with the reference updated from Directive 2006/42/EC. Older lists that place machinery in Section A are out of date. For Section B, Article 2(2) limits direct AI Act application, and delegated acts must amend Machinery Regulation Annex III.
Who is the provider where a vision system is added later?
It depends on the facts, the substantial modification analysis and Article 25. The vision vendor, the machine manufacturer and the deployer can each be a provider in different respects. The parties should agree in writing who is the provider for the modified system, who does the conformity assessment, and who is responsible for monitoring, with the agreement recorded.
When do high risk duties apply for Annex I products?
High risk rules apply for Annex I product embedded systems under Article 6(1) from 2 August 2028, under Article 113 as amended by Regulation (EU) 2026/1744. The sector conformity procedure, the delegated acts and the transitional provisions must be checked on the date of reliance, and preparation should be done before that date.
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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 ↗