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.
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.
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.
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.
Sources (2)
Article 3 defines AI system, provider, deployer, importer, distributor, putting into service, intended purpose, substantial modification, GPAI model, and downstream provider.
means a machine-based system that is designed to operate
Commission FAQ explains the Act's risk-based structure and distinguishes AI systems from general-purpose AI models in public-facing terms.
general-purpose AI models
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.
Sources (3)
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.
This Regulation applies to
Commission policy page explains the AI Act as a risk-based framework for AI developers and deployers in the EU context.
risk-based rules for AI developers and deployers
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.
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.
Sources (2)
Article 3 defines provider, deployer, importer, distributor, and operator; Article 2 includes product manufacturers in scope.
means a provider, product manufacturer, deployer
Commission FAQ gives plain-language examples of provider and deployer roles, including a CV-screening tool developer and a bank using that tool.
providers and deployers of AI systems
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.
Sources (3)
Article 25 sets the role-shift rules for distributors, importers, deployers, third parties, product manufacturers, and upstream suppliers in high-risk AI value chains.
Responsibilities along the AI value chain
Commission GPAI guidelines discuss providers placing GPAI models on the market, downstream modifiers, and when downstream actors can become providers.
Downstream modifiers as providers
Article 1(12) specifies the original-provider cooperation and written supply-chain agreement requirements, including their exceptions.
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.
Sources (1)
Primary source for authorised representative mandates and importer and distributor obligations for high-risk AI systems, plus authorised representatives for third-country GPAI providers.
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.
Yes. Assess each system and activity. You can provide a system under your own name and deploy a different supplier's system.
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.
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.
Sources (4)
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.
shall document its assessment
Commission GPAI guidelines support evidence planning for GPAI provider status, lifecycle documentation, downstream integration, and systemic-risk screening.
whether their model is a general-purpose AI model
Provides the Commission implementation overview and risk-based framework.
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.
Sorena can help you review your EU connection, role and classification evidence.
"laying down harmonised rules on artificial intelligence"
"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"
"A Risk-based Approach"
"risk-based rules for AI developers and deployers"
"To whom does the AI Act apply?"
"general-purpose AI models"
"providers and deployers of AI systems"
"Guidelines on the scope of the obligations"
"Downstream modifiers as providers"
"whether their model is a general-purpose AI model"
Clear answers on AI Act scope, risk categories, provider and user duties, general-purpose models, disclosures, rights, assessments and deadlines.
Find the AI Act deadline for your system or model. Check high-risk dates, transparency duties, older-model transitions and the evidence to prepare.
Check who needs an Article 27 fundamental rights impact assessment, what it must contain and how DPIA reuse, notification and registration work.
Collect model documentation, integration information, copyright records and training summaries. Add testing, incident and security records for systemic risk.
Set up high-risk AI monitoring, identify serious incidents and check reporting deadlines, recipients, deployer escalation and corrective action.
Check the AI Act fine tiers, smaller-organisation caps, GPAI provider fines and the facts authorities consider when deciding a penalty.
Check serious-incident harm, preserve evidence and choose the reporting deadline and recipient for high-risk AI systems and systemic-risk GPAI models.
See which AI Act rules apply now and what comes next. Check high-risk dates, older-model transitions and the difference between legal and standards dates.
Compare AI Act legal duties with ISO/IEC 42001 management-system requirements. See which records can be reused and what certification does and does not cover.
Compare AI Act legal duties with the voluntary NIST AI RMF. Map risk records to specific requirements and identify legal steps that need separate evidence.
Use five checks to establish AI Act scope, exclusions, your role, risk categories and evidence for the decision.
Choose between provider-run internal control, notified-body assessment and a product-law procedure before release.
Classify an AI tool or model before purchase or release. Check EU scope, prohibited uses, high-risk rules, transparency and GPAI duties.
Check each AI tool, decide which duties apply, and give every action an owner and evidence link.
Some high-risk systems use a provider-run assessment. Others need an authorised independent assessor or a product-law assessment.
Check GPAI provider duties for documentation, integrator information, copyright and training summaries, plus extra requirements for systemic-risk models.
High-risk providers must meet system requirements before supply. Deployers must use and monitor the system under the provider's instructions.
Check the system's risk controls, data, documentation, logs, instructions, human oversight and testing before release.
Find high-risk AI examples in recruitment, banking, education, healthcare, public services and products. Check Article 6 conditions and exceptions.
Build a compliance plan for each AI tool: your role, the duties that apply, the evidence needed and the person responsible.
Use EN 18286:2026 to organise provider quality-management procedures and keep evidence that they work for each high-risk system.
Build the technical file and provider records for a high-risk AI system, with owners and evidence links for each field.
Check Article 50 chatbot notices, synthetic-output marking, biometric notices, deepfake disclosures and public-interest text exceptions.
Check Article 5 prohibited AI practices, the narrow exceptions, evidence to retain and the new content prohibitions from 2 December 2026.
Check provider, deployer, importer and distributor roles, when changes create provider duties, and how model and system responsibilities differ.
Find the assessment route for high-risk AI, when a notified body is required, and which declaration, CE-marking and registration records you need.
Check whether software counts as AI, how models differ from systems, when embedded AI is high-risk, and which scope and role evidence to keep.
Understand high-risk AI monitoring under Article 72: the provider plan, deployer feedback, logs, corrective action, incidents and change reviews.
See which industry AI uses fall under Annex III, when Article 6(3) can apply, and what providers must document and register.
See what Article 11 and Annex IV require in high-risk AI technical documentation, from system identity and testing to monitoring and retention.
Check general-purpose model duties, systemic-risk classification, open-source conditions, copyright, training summaries, incidents and application dates.
Check AI interaction notices, technical content marking, biometric notices, deepfake and text disclosures, exceptions, accessibility and deadlines.
Check serious-incident outcomes, reporting roles, 15-, 10- and two-day deadlines, authority recipients, corrective action and the separate model route.
Check who needs an Article 27 fundamental rights impact assessment, what it must cover, and how privacy assessments, notification and registration fit.