Two formal obligations with high symbolic weight
Anyone placing a high-risk AI system on the market must deliver two things that have been standard in product law for decades but are new for AI providers: an EU declaration of conformity (Art. 47) and a CE marking (Art. 48). Neither is a side issue — they are the formal confirmation that a system genuinely meets the requirements set out in Section 2 of the EU AI Act, and they are the first things market surveillance authorities look at and check.
What Art. 47 actually requires
The EU declaration of conformity is written, machine-readable, and signed physically or electronically — and must be issued for each individual high-risk AI system. The key points from the legal text:
- Retention: 10 years from the date the system is placed on the market or put into service, to be kept available for the relevant national authorities (Art. 47(1)).
- Content: It must state that the system meets the requirements set out in Section 2, and must contain the information specified in Annex V — translated into a language that is easily understood by the relevant authority (Art. 47(2)).
- Taking on responsibility: By issuing the declaration, the provider assumes responsibility for compliance with these requirements and must keep the declaration “up to date as appropriate” (Art. 47(4)). This is not a one-off exercise but a living document that must be updated whenever relevant changes are made to the system.
- Multiple regulatory regimes: Where a system also falls under other EU harmonisation legislation that likewise requires a declaration of conformity, only a single, consolidated declaration is to be drawn up (Art. 47(3)).
In practice, this means you need a process that automatically flags, on every substantial change to the system, whether the declaration of conformity is still current — and a filing structure that survives ten years, even once the original product team has long moved on.
What Art. 48 actually requires
The CE marking follows the general principles set out in Art. 30 of Regulation (EC) No 765/2008 (Art. 48(1)), but is supplemented for AI systems with digital-specific requirements:
- Digital systems: Where a high-risk AI system is provided digitally, the CE marking must be accessible via the access interface, or via an easily accessible machine-readable code or other electronic means (Art. 48(2)).
- Visibility: The marking must be visible, legible and indelible — for systems where this is not feasible by nature, it must appear on the packaging or accompanying documentation (Art. 48(3)).
- Notified body: Where a notified body was involved in the conformity assessment procedure under Art. 43, its identification number must be added next to the CE marking — including on any promotional material referring to CE conformity (Art. 48(4)).
- Multiple regulatory regimes: Where the system also falls under other Union legislation requiring a CE marking, the marking automatically confirms conformity with all of those provisions (Art. 48(5)).
For purely software-based systems with no physical carrier, digital CE marking is usually the only sensible route — it then needs to be built firmly into the user interface or its metadata, not just tucked away in an attached PDF.
The deadline that matters here
Art. 47 and 48 are obligations tied to classification as a high-risk AI system. The Digital Omnibus on AI has pushed back the application dates for high-risk obligations: for systems under Annex III, the high-risk obligations — and with them the declaration of conformity and CE marking — will only apply from 2 December 2027 (rather than the originally planned 2 August 2026). For high-risk AI systems covered via Annex I product legislation, the deadline shifts to 2 August 2028. Anyone currently developing such a system should treat these dates as a target for completing the declaration of conformity and the marking process — not as a reason to sit back, since the technical documentation and quality management system that both rely on take considerable lead time to build.
A common gap in practice
The most frequent mistake is treating the declaration of conformity as a form filled in once at the end of a project. In fact, Art. 47(4) requires ongoing maintenance — and Art. 48(4) directly ties the marking to the outcome of the conformity assessment procedure under Art. 43. Without robust processes for version control, change management and document archiving, neither can be produced to the required standard during a market surveillance inspection.
Whether your system even qualifies as a high-risk AI system, and which deadlines apply to you specifically, can be clarified in a few minutes with our free risk check at /einstufung.