A product manufacturer that places an AI system on the market or puts it into service together with its product and under its own name or trademark is treated as a provider for the purposes of the AI Act in the circumstances Article 2 and Article 25 set, while remaining the manufacturer under the product legislation. A system provider, a product manufacturer, an importer, a distributor and a deployer are defined by different acts: development and market placement under a brand, manufacture under product law, first Union market placement of a third-country system, making available in the supply chain, and use under authority. One legal person can hold several of those roles for the same product, and each role's duties must be recorded separately.
How does a manufacturer become an AI Act provider?
Article 2(1)(e) and Article 25 address product manufacturers that place an AI system on the market or put it into service together with their product and under their own name or trademark. Where a manufacturer embeds a supplied AI system in its product and supplies the combined product under its own brand, the manufacturer is the person the deployer and the authority will treat as responsible for the AI system as supplied. The manufacturer must therefore assess the AI system under Articles 5 and 6, meet the provider duties that apply to its route, and coordinate the AI conformity work with the product conformity work. A manufacturer that only assembles components, without placing an AI system on the market under its own name, needs a separate analysis of whether it is a provider, a distributor, or neither on those facts.
How do product and system roles differ in practice?
Product roles are defined by product legislation: manufacturer, authorised representative for the product, importer of the product, and distributor of the product, each with duties under that legislation. System roles are defined by the AI Act: provider, deployer, importer, distributor and authorised representative for the AI system, each with duties under the Act. The two sets of roles can coincide in the same person but they are not identical. A product importer can be an AI system distributor, a product distributor can be an AI system importer, and a product manufacturer can be an AI system provider. The record should map both sets of roles, person by person and product by product, so that a duty under one regime is not assumed to satisfy a duty under the other.
For the broader regulatory framework, see deployer responsibilities.
What happens where one person holds several roles?
Holding several roles is common and lawful, but it requires separate records for each role. A manufacturer-provider must keep product technical documentation and AI technical documentation, with the Annex IV information identifiable in the combined file. A provider-deployer must keep provider evidence and deployer operational records separately, even where the same team produces both. An importer-distributor must meet the broader importer verification and file duties for the import act, and the distributor verification duties for later supply acts. The organisation should assign an owner for each role, with a role map that shows who is responsible for each duty, so that a change in one role, such as a new importer, does not silently affect another role's records.
How should supplied components be handled?
A supplied AI component, model or system that is integrated into a product should be treated as a supply with an information flow, not as a purchase that transfers responsibility. The manufacturer-provider should obtain the component's intended purpose, capabilities, limitations, documentation, and update practice from the supplier, and should record the assessment that the component, as integrated, meets the AI Act requirements for the combined product. The supplier should provide the information the manufacturer needs, and should inform the manufacturer of changes that affect compliance or purpose. Where the supplier is also the provider of the component as a standalone system, the two provider records, for the component and for the combined product, should be kept separately and linked by version.
What about own-brand and third-party brands?
Branding decides several role questions. A system placed on the market under the manufacturer's own brand makes the manufacturer the provider for that system. A system placed on the market under a supplier's brand, where the manufacturer only integrates it without rebranding, leaves the supplier as provider for the system, although the manufacturer remains manufacturer for the product and may acquire provider status through substantial modification or purpose change under Article 25. A distributor that rebrands a system becomes the provider under Article 25. The brand on the product, the packaging, the documentation and the marketing should therefore be consistent, and any rebranding decision should trigger a role review before the rebranded product is supplied.
Continue with provider responsibilities.
What is not decided by this guide?
This guide explains the relationship between product and system roles in outline. It does not decide whether any particular manufacturer, integrator or supplier is a provider, importer or distributor, or whether Article 25 applies. Those questions need the manufacture, branding, market act and modification facts, read against Article 2, Article 3 and Article 25 in the consolidated text and the applicable product legislation. Role mapping for a product with an embedded AI system should be confirmed with a competent authority or legal adviser, and with the notified body where one is involved, before the product is placed on the market.
Frequently asked questions
Is a manufacturer automatically the AI provider for embedded AI?
Not automatically. The manufacturer is treated as provider where it places the AI system on the market or puts it into service together with its product under its own name or trademark, in the circumstances Article 2 and Article 25 set. The branding, market act and modification facts must be checked.
Can a supplier remain provider after integration into a product?
Yes, where the system remains under the supplier's brand and the integrator does not rebrand, substantially modify, or change the purpose in a way that triggers Article 25. The integrator remains manufacturer for the product, and the two records should be kept separately and linked.
Does product CE marking cover AI Act conformity?
For Annex I Section A products, AI requirements are assessed within the product conformity procedure, and the product CE marking reflects that combined assessment. For Section B products, the position differs, and the sectoral regime carries the substance. The route must be identified from the Annex I section covering the product.
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 ↗European Commission regulatory framework for AI ↗