Provider obligations (Article 16)
The provider:
- Ensures the system meets the requirements in Articles 9 through 15.
- Has a quality management system under Article 17.
- Keeps technical documentation per Article 11 and Annex IV.
- Keeps automatically generated logs (Article 12).
- Runs the conformity assessment under Article 43.
- Draws up the EU declaration of conformity (Article 47) and affixes the CE marking (Article 48).
- Registers the system in the EU AI Database (Article 49).
- Operates a post-market monitoring system (Article 72).
- Reports serious incidents under Article 73 — generally 15 days, 10 days for death/serious harm, 2 days for widespread fundamental-rights breach.
- Cooperates with market surveillance authorities under Articles 79–82.
Deployer obligations (Article 26)
The deployer:
- Uses the system in accordance with instructions for use.
- Assigns human oversight to staff with the necessary competence, training, authority, and support.
- Ensures input data is relevant and representative for the intended purpose, where the deployer has control over input data.
- Monitors operation per the provider's instructions; suspends use if there is reason to believe a serious incident is imminent or has occurred.
- Reports incidents to the provider and to the market surveillance authority under Article 73.
- Keeps automatically generated logs for at least six months.
- Informs workers and their representatives before deploying high-risk AI in the workplace (Article 26(7)).
- Informs natural persons subject to a decision, on request, with an explanation under Article 26(11) and Article 27 where applicable.
- Public bodies and certain private deployers complete a fundamental rights impact assessment under Article 27.
Article 27 — who must do a FRIA
- Bodies governed by public law (most public-sector deployers).
- Private entities providing public services.
- Private deployers in Annex III §5(b) creditworthiness.
- Private deployers in Annex III §5(c) life-and-health insurance pricing.
- Private deployers in Annex III §1 (biometric identification).
The FRIA covers the intended purpose, the categories of natural persons affected, the foreseeable impact on fundamental rights (including non-discrimination), the bias risks, the human-oversight design, and the mitigations. It is filed with the market surveillance authority before first use.
Article 25 — when the deployer becomes a provider
Article 25 captures four situations where a downstream actor inherits the full Article 16 provider regime:
- The actor puts its name or trademark on a high-risk system already placed on the market.
- The actor makes a substantial modification to a high-risk system already on the market in a way that does not change its high-risk classification.
- The actor modifies the intended purpose of an existing AI system (including a non-high-risk system or a GPAI model) in a way that brings the resulting system into a high-risk category.
- The actor takes a GPAI model and integrates it into a high-risk AI system in a way that the GPAI provider would not have foreseen.
In each case, the original provider's obligations do not disappear — but the new actor inherits them in addition. Practically, an enterprise that fine-tunes a GPAI model and deploys it as a high-risk hiring tool becomes a provider of that derived system.
Where the responsibility transfers in practice
| Topic | Provider | Deployer |
|---|---|---|
| Conformity assessment | Yes (Art 43). | No (unless becomes a provider under Art 25). |
| Technical documentation | Yes (Art 11). | No. |
| Risk management lifecycle | Yes, system-level (Art 9). | Operational risk in deployment context. |
| Data governance | Yes, training and validation (Art 10). | Yes, input data within the deployer's control (Art 26(4)). |
| Human oversight | Designs for it (Art 14). | Operates it (Art 26(2)). |
| Logging | Designs the logging (Art 12). | Keeps logs at least 6 months (Art 26(6)). |
| Worker information | — | Yes, before deployment (Art 26(7)). |
| FRIA | — | Yes, public bodies + §1/§5(b)/§5(c) private (Art 27). |
| Serious-incident reporting | To market surveillance authority. | To provider and market surveillance authority. |
| EU Database registration | System registration (Art 49(1)). | Annex III deployer registration where applicable (Art 49(3)–(4)). |
Procurement implications
Procurement contracts should explicitly allocate the risk of becoming a provider under Article 25. A contract that lets the deployer fine-tune the model on its own data, repoint the system to new use cases, or rebrand the system can shift Article 16 burden onto the deployer. The conservative procurement clause keeps the original provider in the provider role for the contract scope and ring-fences any deployer modifications.