EU AI Act Article 48: CE Marking Rules for High-Risk AI Systems

What Article 48 Covers

Article 48 of Regulation (EU) 2024/1689 brings the most recognisable symbol of EU product law, the CE marking, into the world of artificial intelligence. The CE marking on a high-risk AI system signals that the provider declares the system to comply with the requirements of the AI Act, having completed the applicable conformity assessment and drawn up the EU declaration of conformity. For deployers, importers, distributors and market surveillance authorities, it is the first visible compliance checkpoint.

Article 48(1) anchors the marking in the general framework: the CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008. Those principles include that the marking may only be affixed by the manufacturer or its authorised representative, only to products for which Union legislation provides for it, and that affixing it signals responsibility for conformity. Affixing markings whose meaning could be confused with the CE marking is not permitted.

The Digital CE Marking

The AI Act had to solve a problem its predecessors did not face: many AI systems have no physical surface. Article 48(2) provides that for high-risk AI systems provided digitally, a digital CE marking shall be used only if it can easily be accessed via the interface from which that system is accessed or via an easily accessible machine-readable code or other electronic means. In practice, providers of software-only systems can satisfy the marking duty through the product interface, documentation screens or machine-readable mechanisms, provided access is genuinely easy.

Visibility, Legibility, Timing

Article 48(3) carries the classical formula: the CE marking shall be affixed visibly, legibly and indelibly for high-risk AI systems. Where that is not possible or not warranted on account of the nature of the high-risk AI system, it shall be affixed to the packaging or to the accompanying documentation, as appropriate. The marking must be in place before the system is placed on the market, since it is the visible counterpart of the declaration of conformity drawn up at that point.

The Notified Body Number

Article 48(4) addresses third-party assessed systems: where applicable, the CE marking shall be followed by the identification number of the notified body responsible for the conformity assessment procedures set out in Article 43. The identification number shall be affixed by the notified body itself or, under its instructions, by the provider or the provider's authorised representative. The identification number shall also be indicated in any promotional material which mentions that the high-risk AI system fulfils the requirements for CE marking.

Article 48(5) adds a coordination rule: where high-risk AI systems are subject to other Union law which also provides for the affixing of the CE marking, the marking shall indicate that the system also fulfils the requirements of that other law. One marking, multiple legal meanings.

How to Implement Article 48 in Practice

1. Respect the sequence. The marking comes after the Article 43 conformity assessment and the Article 47 declaration of conformity, and before placing on the market. Affixing a CE marking without a completed assessment is itself a breach.
2. For software systems, design the digital marking location deliberately: an about screen, an admin console compliance page or a machine-readable endpoint, reachable without obscure navigation from the interface through which the system is accessed.
3. For embedded systems, coordinate with the physical product's existing marking under the sectoral legislation and apply Article 48(5) so the single marking covers all applicable regimes.
4. If a notified body was involved, integrate its identification number next to the marking and audit promotional materials for the parallel duty, which marketing teams routinely miss.
5. Control marking integrity over updates: indelible, in the digital context, means the marking should not silently disappear or become inaccessible in a redesign or release.
6. Train channel partners: importers verify the marking under Article 23, distributors under Article 24, so the provider should document where the marking lives and how to confirm it.

A Concrete Example

A provider offers a cloud-based AI system for scoring vocational training applicants, high-risk under Annex III point 3. After completing internal-control conformity assessment and signing its declaration of conformity, the provider adds a compliance page directly linked from the application's main settings menu showing the CE marking, the system name and version, the provider identity and a machine-readable JSON endpoint with the same data. No notified body number applies, because Annex VI internal control was the applicable procedure. Screenshots and the endpoint specification go into the technical documentation, and the reseller agreement points distributors to the page for their Article 24 checks.

How Article 48 Connects to Other Provisions

Article 16(h) and (i) make affixing the CE marking part of the provider's core obligations. The marking presupposes Article 43 assessment and the Article 47 declaration, and is verified downstream by importers and distributors under Articles 23 and 24. Article 49 registration and the Annex VIII data set complete the public traceability picture. Member States must take action against improper use of the marking, and operating with an unjustified marking exposes the provider to market surveillance measures under Chapter IX and penalties under Article 99. The general principles of Regulation (EC) No 765/2008 continue to apply across all CE-marked products.

Actions to Take Before August 2, 2026

Providers should decide their digital marking implementation now and wire it into release engineering, so that every market-bound build carries the marking, the right version references and, where applicable, the notified body number. Importers and distributors should add marking verification to their intake checklists. A marking is cheap to display and expensive to display falsely; the discipline lies in only affixing it when the underlying assessment genuinely supports it. This article provides general information about Regulation (EU) 2024/1689 and is not advice on any specific product marking.

This article is for informational purposes only and does not constitute legal advice. Regulatory requirements change frequently — verify current rules with official sources. Built by Sawai Gyoseishoshi Office, Hiroshima, Japan.