Manufacturing uses AI for quality control, predictive maintenance, and in products with built-in intelligence. The EU AI Act (Regulation (EU) 2024/1689) interacts here particularly closely with sector-specific product legislation. The Regulation applies directly in the Member States; no separate national implementing act is required for the AI Act itself.
AI in products covered by Annex I
Annex I to the AI Act covers sector-specific product legislation. Many industrial products – for example, machinery and other equipment – are already covered by such harmonised product legislation. When an AI system is a safety component of, or is itself, a product covered by the Annex I legislation, the interplay between the AI Act's requirements and the existing sectoral legislation comes into play.
It is therefore essential to distinguish between AI that forms part of a regulated product and AI that is used solely internally in the manufacturing process.
The sectoral procedure in Article 43(3)
Conformity assessment is governed by Article 43. Article 43(3) means that the conformity assessment for high-risk systems covered by certain Annex I legislation is integrated into the procedure that already applies under the sectoral legislation. The intention is that the AI requirements are examined within the existing product procedure rather than through a separate, parallel procedure.
Quality control and predictive maintenance
AI for quality control and predictive maintenance used solely internally in production is normally not covered by the high-risk categories of Annex III, because these categories concern specifically designated societal domains. Such internal systems may nevertheless be caught by other parts of the Regulation, for example the AI literacy requirement in Article 4 and, where applicable, the transparency requirements in Article 50.
The delineation is central: a system embedded in an Annex I-regulated end product is assessed differently from a tool used alongside the production line.
Roles: provider or deployer
The Regulation distinguishes between provider and deployer. A manufacturer that builds AI into its product and places it on the market is typically a provider. A company that purchases an AI tool for internal use is typically a deployer.
Article 25 can reclassify a deployer as a provider, for example following a substantial modification of the system or putting its own name on it. For high-risk systems, the deployer's obligations are set out in Article 26, which includes, among other things, following the provider's instructions for use, ensuring human oversight, and monitoring operation.
Timeline
- 2 February 2025: Article 4 (AI literacy) and Article 5 (prohibited practices) in force.
- 2 August 2026: Article 50 (transparency) applies. The Annex III obligations for deployers apply from this date under the original timeline.
- 2 December 2027: Proposed deferral of the Annex III obligations via the Digital Omnibus (approved by the European Parliament on 16 June 2026; the Council awaits OJ publication). This is a Digital Omnibus proposal and is not yet in force.
Penalties
Under Article 99, prohibited practices under Article 5 can result in fines of up to EUR 35 million or 7 % of global annual turnover. Infringements of, among other things, high-risk obligations and Article 50 can result in up to EUR 15 million or 3 %. Incorrect information can result in up to EUR 7.5 million or 1 %.
Before procurement
- Determine whether the AI system forms part of a product covered by Annex I sectoral legislation.
- Investigate how Article 43(3) affects the conformity assessment procedure.
- Distinguish between embedded product AI and internal tools for quality control/maintenance.
- Establish your role: provider or deployer – and monitor Article 25.
- Ensure AI literacy under Article 4.
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This page is general information about the AI Act and does not constitute legal advice.