Affixation Requirements

Article 48 requires high-risk AI systems to bear the CE marking after the Declaration of Conformity is signed. For digital systems, the marking is displayed in the user interface and accompanying documentation. It must be visible, legible, and indelible. The Conformity Assessment Coordinator affixes the marking before the system is placed on the market or put into service.

The CE marking signals to deployers, users, and authorities that the system has undergone conformity assessment and that the provider has declared compliance. For software-only systems, “indelible” means the marking cannot be removed or obscured through normal use of the system; embedding it in the system’s interface and documentation satisfies this requirement.

Where the system is also subject to other Union harmonisation legislation (Annex I products), a single CE marking indicates conformity with all applicable legislation. The Conformity Assessment Coordinator confirms that the marking covers the AI Act and all other applicable regulations before affixation.

Key outputs

• CE marking displayed in user interface and documentation
• Visible, legible, indelible placement
• Affixed before market placement or service entry
• Module 10 AISDP documentation

Affixing to Non-Conforming System — Offence (Art. 48, Art. 99)

Affixing the CE marking to a system that has not completed conformity assessment, or that is non-conforming, constitutes a breach of the CE marking requirements under Article 48 and the general principles in Article 30 of Regulation (EC) No 765/2008, carrying penalties under Article 99. The offence falls within Tier 2 (breach of obligations under Articles 43–49), exposing the organisation to fines of up to EUR 15 million or 3% of global annual turnover, and creating personal accountability for the individual who authorises affixation. The AI Governance Lead or Conformity Assessment Coordinator must be confident that the conformity assessment supports the marking before authorising it.

The safeguard against improper affixation is the assessment process itself. The Declaration of Conformity must be signed before the CE marking is affixed. The Declaration can only be signed when the Assessment Report supports it. The Assessment Report is supported by the assessment evidence. This chain of dependency ensures that the CE marking cannot lawfully be affixed without a complete, documented basis.

Organisations should establish a formal CE marking approval step in their deployment workflow, requiring explicit confirmation from the Conformity Assessment Coordinator that the Declaration has been signed and the marking is authorised.

Key outputs

• Formal CE marking approval step in deployment workflow
• Chain of dependency (assessment, report, declaration, marking)
• Offence and penalty awareness for authorising personnel
• Module 10 AISDP documentation