Article 48 — CE marking (EU AI Act)

Article 48 of Regulation (EU) 2024/1689 — CE marking. Official text, practical interpretation, key obligations and compliance implications.

Official Text Summary

Article 48 of Regulation (EU) 2024/1689 (EU AI Act) establishes the rules governing CE marking for high-risk AI systems. The CE marking constitutes the visible declaration by the provider that a high-risk AI system conforms to the requirements of the Regulation and, where applicable, to other Union harmonisation legislation that also requires CE marking.

Paragraph 1 provides that the CE marking must be affixed visibly, legibly, and indelibly to the high-risk AI system — or, where that is not possible due to the nature of the system, to its packaging or to the accompanying documentation — before the system is placed on the market or put into service.

Paragraph 2 prohibits affixing any marking, sign, or inscription that is likely to mislead third parties regarding the meaning or form of the CE marking. Any other markings may be affixed only if they do not impair the visibility, legibility, or meaning of the CE mark.

Paragraph 3 specifies that where a high-risk AI system is also subject to other Union legislation requiring CE marking, the single CE mark signals compliance with all applicable requirements, provided all conditions of each relevant act are met.

Paragraph 4 requires that, where a notified body has participated in the conformity assessment procedure, the notified body's identification number must be displayed alongside the CE marking. The identification number must be affixed by the notified body itself or, under its instruction, by the provider.

The format and general rules for the CE mark are governed by Annex V of the Regulation, read in conjunction with Regulation (EC) No 765/2008.

What This Means in Practice

For providers of high-risk AI systems, CE marking is the final, outward-facing step in the conformity journey — but it is a legally significant one, not a formality.

Providers must ensure that CE marking is affixed only after the applicable conformity assessment procedure (under Articles 43 and 44) has been completed, the EU declaration of conformity (Article 47) has been drawn up, and all relevant technical documentation (Article 11) is in order. Affixing the mark prematurely exposes the provider to enforcement action and potential withdrawal from the market.

Where to affix the mark requires careful judgment. For embedded or software-only AI systems that have no physical housing, the mark must appear on packaging or accompanying documentation. Providers should document the rationale for placement decisions.

Notified body involvement adds a layer of procedural obligation: if a notified body was engaged (as required for certain high-risk categories under Article 43), the notified body's four-digit identification number must appear next to the CE mark. Coordinating this with the notified body early — rather than at the point of market launch — avoids delays.

Importers and distributors must verify that CE marking has been correctly affixed and that the accompanying EU declaration of conformity is available before making the system available on the market (see Articles 23 and 24). They should not place a system on the market if CE marking is missing or appears irregular.

Practical example: A provider of an AI-based medical diagnostic tool subject to both the EU AI Act and Regulation (EU) 2017/745 (MDR) must satisfy conformity requirements under both instruments before affixing a single CE mark. Failure to meet either set of requirements invalidates the mark.

Key Obligations

• Affix CE marking before market placement: Providers must apply the CE mark to the high-risk AI system, its packaging, or accompanying documentation before placing it on the market or putting it into service in the EU.
• Complete conformity assessment first: CE marking may only be affixed after the applicable conformity assessment procedure under Article 43 has been successfully completed; affixing it beforehand is prohibited.
• Include notified body identification number: Where a notified body was involved in the conformity assessment, the provider must display that body's identification number alongside the CE mark.
• Avoid misleading markings: No marking, sign, or inscription that could mislead third parties about the meaning or form of the CE mark may be affixed to the system or its documentation.
• Satisfy all applicable Union legislation: Where other Union harmonisation legislation also requires CE marking, the provider must comply with all applicable acts before relying on a single CE mark as evidence of conformity.
• Ensure visibility and legibility: The CE mark must be affixed in a visible, legible, and indelible manner in accordance with the format rules in Annex V of the Regulation.

Relationship to Other Articles

Article 48 sits at the culmination of the Chapter 5 conformity chain and cannot be read in isolation. It is directly dependent on Article 43 (conformity assessment procedures), which specifies the process a provider must complete before CE marking becomes lawful, and on Article 47 (EU declaration of conformity), the formal document that underpins the mark.

Article 11 (technical documentation) and Article 17 (quality management system) establish the substantive conditions that must be satisfied before the declaration — and therefore the mark — can be legitimately issued.

Articles 23 and 24 extend the obligations downstream: importers and distributors must verify CE marking before making a system available, creating a chain of accountability across the supply chain.

Article 49 (registration) operates in parallel: providers of certain high-risk systems must register in the EU database before or alongside market placement, meaning CE marking alone is insufficient for full compliance.

Finally, Annex V of the Regulation and Regulation (EC) No 765/2008 govern the graphical and procedural rules for the CE mark itself.

Compliance Timeline

The EU AI Act entered into force on 1 August 2024 (twenty days after publication in the Official Journal on 12 July 2024). Application of the Regulation is phased:

• 2 February 2025 — Prohibitions on unacceptable-risk AI practices (Article 5) became applicable.
• 2 August 2025 — Rules on general-purpose AI models (Title VIII) and governance provisions became applicable.
• 2 August 2026 — High-risk AI systems covered by Annex III become fully subject to all obligations, including conformity assessment and CE marking requirements under Article 48, for newly placed systems.
• 2 August 2027 — Extended deadline for high-risk AI systems governed by existing product safety legislation listed in Annex I (e.g., machinery, medical devices, toys) where those systems were already placed on the market before August 2026 under the earlier sectoral legislation.

Providers of high-risk AI systems should treat the period leading up to August 2026 as active preparation time: completing conformity assessments, engaging notified bodies where required, finalising technical documentation, and establishing internal processes for correct CE mark application — so that no system is placed on the EU market without a lawfully affixed CE mark from the applicable date.