Article 25(3)
UpcomingConditional timingAssume Provider Responsibilities as the Product Manufacturer of Certain Annex I Section A High-Risk AI
Applies to Product Manufacturer; Annex I Section A High-Risk AI safety component.
- Actors
- Product Manufacturer
- AI class
- Annex I Section A High-Risk AIHigh-Risk AI
- Themes
- Third Parties & Supply ChainGovernance & Accountability
Tracker Networks Guidance
If your organization manufactures a product covered by Union harmonisation legislation in Annex I Section A and a high-risk AI system is a safety component of that product, Article 25(3) treats the product manufacturer as the provider when the AI system is placed on the market together with the product under the manufacturer's name or trademark, or is put into service under that name or trademark after the product has been placed on the market. When this applies, the manufacturer is subject to the Article 16 provider obligations. Review the Provider obligations in this library as well as the Annex I Section A conformity-assessment requirements.
Official text
3. In the case of high-risk AI systems that are safety components of products covered by the Union harmonisation legislation listed in Section A of Annex I, the product manufacturer shall be considered to be the provider of the high-risk AI system, and shall be subject to the obligations under Article 16 under either of the following circumstances: (a) the high-risk AI system is placed on the market together with the product under the name or trademark of the product manufacturer; (b) the high-risk AI system is put into service under the name or trademark of the product manufacturer after the product has been placed on the market.
Timing depends on the system
- 2 Dec 2027 — Article 6(2) / Annex III high-risk AI
- 2 Aug 2028 — Article 6(1) / Annex I Section A high-risk AI
- 2 Dec 2027 — Pre-existing Annex III high-risk AI type/model first placed on the market or put into service before 2027-12-02
- 2 Aug 2028 — Pre-existing Article 6(1) / Annex I high-risk AI type/model first placed on the market or put into service before 2028-08-02
- 2 Aug 2030 — Pre-existing high-risk AI intended to be used by public authorities
Suggested controls
Related risks
AI Value Chain Compliance Failure
Suppliers, importers, distributors or authorised representatives may not provide the information, controls or cooperation needed for high-risk AI compliance.