Provider and Deployer (EU AI Act)
The two primary role categories in the AI Act. Providers place systems on the market; deployers put them into use in a professional capacity.
Definition
Article 3(3) defines a provider as a natural or legal person that develops an AI system or has one developed and places it on the market or puts it into service under its own name or trademark. Article 3(4) defines a deployer as a natural or legal person using an AI system under its authority, except where use is in the course of a personal non-professional activity. Obligations differ sharply between the two.What this means in practice
A device manufacturer is almost always the provider for its AI-enabled device. A hospital or clinic that uses the device is a deployer with a narrower but real set of duties, including human oversight, input-data governance, monitoring, and (for certain public bodies and services) a Fundamental Rights Impact Assessment. Contracts should make the split explicit.- •Assuming deployers have no AI Act obligations. Article 26 imposes concrete duties on them.
- •Rebranding a system under a hospital's name without recognizing that this can make the hospital the provider under Article 25.
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsAssessment deployers of certain high-risk AI systems must complete before first use.
AI systems captured by Article 6 of the EU AI Act because they are safety components of regulated products or listed in Annex III.
More in Regulatory
· Same categoryFDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request.
Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.
510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.
Where this term appears across MedTech Terms.
Primary references
3 sources- 1
Regulation (EU) 2024/1689, Article 3 and Article 26VerifiedEUR-Lexeur-lex.europa.eu
- 2
FDA - Medical DevicesVerifiedFDAfda.gov
- 3
European Commission - Medical DevicesVerifiedEuropean Commissionhealth.ec.europa.eu
Inline markers like [1] jump to the matching reference above.