Scope GuideEU

EU AI Act Does it apply to you?

The AI Act can apply when you build, supply or use AI in the EU. It can also cover AI outputs used in the EU.

Identify the system or model, the EU connection and your role before assigning duties.

Author
Sorena AI
Published
May 9, 2026
Updated
Oct 21, 2026
Overview

Start with what the tool does and where it is used. Then identify who develops, brands, imports and operates it. One company can hold several roles, and a change to a tool or its intended use can change those roles.

Section 1

1. Identify the system or model

An AI system infers how to produce predictions, content, recommendations or decisions from its inputs. It operates with some autonomy, may adapt after deployment, and can influence a physical or digital environment.

A general-purpose AI (GPAI) model can perform many distinct tasks and can be integrated into other systems. A reusable model and the chatbot, scoring tool or product built with it need separate assessments.

Check the inference capability rather than the vendor label. The definition does not require machine learning, continuous learning or a particular level of complexity.

  • Name and version: identify the system, model or both, its owner and release channel.
  • System facts: describe its objectives, inputs, outputs, autonomy, possible adaptation, users, affected people and operating environment.
  • Model facts: identify the provider, capabilities, release method, planned integrations and EU market availability.
  • Ordinary automation: explain whether the tool meets the inference test before treating it as an AI system.
Section 2

2. Find the EU connection

Article 2 covers providers supplying AI systems or GPAI models to the EU market, providers putting systems into service in the EU, and deployers established or located in the EU. It also covers specified supply-chain roles and affected people in the EU.

A provider or deployer outside the EU can be covered when the system produces outputs used in the EU. Record where the system is supplied and operated, who it affects and where its outputs are used.

Check each exclusion against the actual activity. The pre-market research and development exclusion does not cover real-world testing. The free and open-source system exclusion does not cover high-risk systems or systems falling under Article 5 or Article 50.

For regulated products, identify the exact law in Annex I. The 2026 amendment limits direct AI Act duties for Section B products and moves machinery to that section. Check the sector law before assigning the full standalone high-risk requirements.

  • EU triggers: record market supply, first use, deployer location, output use, affected people and relevant importer, distributor, manufacturer or representative roles.
  • Possible exclusions: check personal non-professional use, pre-market research or development, solely scientific research, and military, defence or national-security purposes.
  • Global releases: note any differences in EU customers, users, features or outputs.
  • Open-source releases: retain licence and release facts, then check high-risk status, prohibited uses and transparency duties.
Section 3

3. Match your role to what you do

Your role follows your activity. You may use a supplier's tool as a deployer, release your own tool as a provider, and import another tool from outside the EU.

Contracts help establish the facts. Check who develops, brands, supplies, modifies and operates each system or model before accepting a role label.

  • Provider: develops a system or GPAI model, or has it developed, and places it on the market under its own name or trademark; for a system, this also includes putting it into service under that name or trademark.
  • Deployer: uses an AI system under its authority, except for purely personal non-professional use.
  • Importer: is based in the EU and places a system bearing a non-EU supplier's name or trademark on the EU market.
  • Distributor: makes a system available on the EU market as a supply-chain actor other than the provider or importer.
  • Product manufacturer: supplies or puts a system into service with its product under its own name or trademark.
Section 4

4. Check whether a change makes you the provider

Under Article 25, you can take on high-risk provider duties if you rebrand an existing high-risk system, substantially modify it while it remains high-risk, or change a system's intended purpose so it becomes high-risk. This can affect importers, distributors, deployers and other third parties.

A manufacturer can also be the provider of a high-risk safety component in an Annex I Section A product. This applies when it supplies the system with its product under its own name or trademark, or later puts the system into service under that name or trademark.

Before accepting the new role, request technical documentation, known limitations, failure modes and testing access from the original provider. Amended Article 25(2) requires cooperation unless the original provider clearly prohibited changing its system into a high-risk system.

  • Rebranding: review white-label releases, customer-specific relaunches and private-label distribution.
  • Substantial modification: assess model replacements, architecture changes, data pipelines, performance changes and new operating contexts.
  • New purpose: review any move from general support to an Annex III use, such as recruitment ranking.
  • Written support agreement: for a high-risk system, agree on supplier information, capabilities, technical access and assistance. Article 25(4) exempts specified publicly available free and open-source components from this agreement duty; GPAI models do not receive that exemption.
Section 5

5. Complete supply-chain checks

Importers and distributors have their own checks for high-risk systems. A CE mark alone does not establish that they have completed those checks.

Before EU market placement, importers check the provider's conformity assessment and technical documentation, declaration, CE marking, instructions and representative appointment. Before making a system available, distributors check the marking, declaration copy, instructions and importer details.

Both must stop supply if they have reason to believe a system is non-compliant. Risk concerns also trigger their separate notification duties.

A non-EU provider's authorised representative needs a written mandate under Article 22 or 54. The provider retains the duties that the law assigns to it, including ensuring compliance before market placement.

  • Importer: retain provider and representative details, assessment and documentation checks, declaration, marking, instructions, importer contact details and storage or transport controls.
  • Distributor: retain supplier and importer details, marking and document checks, supply date, storage or transport controls, complaints, risk signals and approval.
  • Representative: retain the accepted mandate, covered systems or models, available evidence, authority-contact procedure, retention arrangements and termination triggers.
  • Stop and review: missing required documents, suspected non-compliance, serious risk, withdrawal, recall or a modification that could make you the provider.
Section 6

6. Keep the decision and review it after changes

Keep the facts, legal basis, reviewer and approval together. For high-risk candidates, record either the product-law route or the Annex III use case.

For the Article 6(3) Annex III exception, establish no significant risk of harm and at least one listed task condition: a narrow procedural task, improvement of completed human work, properly reviewed detection of decision patterns, or preparation for an Annex III assessment. The exception cannot cover an Annex III system that profiles people. Document the assessment before market placement or first use and keep the Article 49(2) registration record.

Record the date for each duty. The original prohibitions have applied since 2 February 2025; GPAI duties since 2 August 2025. The new content prohibitions apply from 2 December 2026.

The 2026 amendment was published on 24 July and entered into force on 27 July 2026. It retains 2 August 2026 as the general application date. Chapter III Sections 1-3, except Article 6(5), apply from 2 December 2027 for Annex III systems and 2 August 2028 for Article 6(1) product-linked systems.

Can we be both a provider and a deployer?

Yes. Assess each system and activity. You can provide a system under your own name and deploy a different supplier's system.

Can the Act cover a company with no EU office?

Yes. Article 2 can cover non-EU providers and deployers when a system's outputs are used in the EU, as well as providers supplying the EU market.

What should we keep to support our decision?

Keep the system or model description, EU connection, role map, intended purpose, supply chain, high-risk analysis, any exception evidence and the changes that require a new review.

  • Save the Article 3 definition analysis and Article 2 EU scope basis with the system inventory.
  • Attach intended purpose, functions, interface, deployment facts, affected people, supplier contracts and approval history.
  • For high-risk candidates, save the product law or Annex III entry, any Article 6(3) exception analysis and registration position.
  • For GPAI models, save provider details, model documentation, integration assumptions and systemic-risk screening.
  • Review after rebranding, substantial modification, a new purpose, EU expansion, a new user group, changed output use or a supplier model update.
Primary sources

References and citations

eur-lex.europa.eu6 citations
Referenced sections
  • Primary legal text used for Article 2 scope, Article 3 definitions, Article 6 high-risk classification, Article 25 role-shift rules, Article 49 registration evidence, and Annex IV technical-documentation evidence.
  • Article 3 defines AI system, provider, deployer, importer, distributor, putting into service, intended purpose, substantial modification, GPAI model, and downstream provider.
  • Article 2 provides the scope triggers for EU market placement, putting into service, EU deployers, EU-used outputs, importers, distributors, product manufacturers, authorised representatives, and exclusions.
Show 3 more
  • Article 3 defines provider, deployer, importer, distributor, and operator; Article 2 includes product manufacturers in scope.
  • Article 25 sets the role-shift rules for distributors, importers, deployers, third parties, product manufacturers, and upstream suppliers in high-risk AI value chains.
  • Article 6 sets high-risk classification and documentation of non-high-risk assessments for Annex III systems; Annex IV lists technical-documentation evidence for high-risk systems.
"laying down harmonised rules on artificial intelligence"
More quoted passages
"means a machine-based system that is designed to operate"
"This Regulation applies to"
"means a provider, product manufacturer, deployer"
"Responsibilities along the AI value chain"
"shall document its assessment"
digital-strategy.ec.europa.eu3 citations
Referenced sections
  • Commission policy page used for the AI Act risk-based framework and examples of high-risk, transparency-risk, and minimal-risk categories.
  • Commission policy page explains the AI Act as a risk-based framework for AI developers and deployers in the EU context.
  • Provides the Commission implementation overview and risk-based framework.
"A Risk-based Approach"
More quoted passages
"risk-based rules for AI developers and deployers"
digital-strategy.ec.europa.eu3 citations
Referenced sections
  • Commission FAQ used for public-facing explanation of who the AI Act applies to, risk-based classification, high-risk examples, and GPAI model treatment.
  • Commission FAQ explains the Act's risk-based structure and distinguishes AI systems from general-purpose AI models in public-facing terms.
  • Commission FAQ gives plain-language examples of provider and deployer roles, including a CV-screening tool developer and a bank using that tool.
"To whom does the AI Act apply?"
More quoted passages
"general-purpose AI models"
"providers and deployers of AI systems"
ec.europa.eu3 citations
Referenced sections
  • Commission guidelines used for GPAI model scope, providers placing GPAI models on the market, downstream modifiers, and downstream-provider analysis.
  • Commission GPAI guidelines discuss providers placing GPAI models on the market, downstream modifiers, and when downstream actors can become providers.
  • Commission GPAI guidelines support evidence planning for GPAI provider status, lifecycle documentation, downstream integration, and systemic-risk screening.
"Guidelines on the scope of the obligations"
More quoted passages
"Downstream modifiers as providers"
"whether their model is a general-purpose AI model"
eur-lex.europa.eu3 citations
Referenced sections
  • Binding amendment used for the revised high-risk application dates and the direct-application limits for Article 6(1) systems related to Annex I Section B products.
  • Supports the amended Article 2 treatment of Article 6(1) systems related to Annex I Section B products and the move of machinery to the sectoral route.
  • Binding amendment published on 24 July 2026 and entering into force on 27 July 2026; supports the revised high-risk application dates and sector-law treatment.
eur-lex.europa.eu
Referenced sections
  • Primary source for authorised representative mandates and importer and distributor obligations for high-risk AI systems, plus authorised representatives for third-country GPAI providers.
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