Articles 43-49: conformity assessment, CE and registration
The route from assessment to CE marking and EU database registration before market placement of high-risk AI.
The official source remains authoritative. This general interpretation is not legal advice.
- Status
- Upcoming
- Application date
- 2 December 2027
- Version
- 1.0.0
- Last reviewed
- 8 August 2026
Who this is relevant to
When this applies
Provider of an AI system
A party that develops or has an AI system developed and places it on the market under its own name.
Body governed by public law
A deployer that is a body governed by public law.
- 1The provider places a high-risk system on the market; public deployers also register their use.
What the official source establishes
Article 43 governs the conformity assessment, Article 47 the EU declaration of conformity, Article 48 the CE marking and Article 49 the registration in the EU database before market placement or putting into service, including registration of the Article 6(3) assessment.
For the Annex III route this requirement applies from 2 December 2027; for high-risk AI in regulated products (Annex I) from 2 August 2028.
Our interpretation
For buyers this is the simplest supplier check there is: ask for the declaration of conformity and the registration number. No declaration means the system may not be there by 2 December 2027.
What you can do now
Plan the conformity route backwards from 2 December 2027: standards selection, assessment, declaration and registration together take months, not weeks.
- 01
Complete the conformity route before market placement
Select the correct assessment procedure, draw up the EU declaration of conformity, affix the CE marking and register in the EU database.
What to retain
Conformity file
The assessment, EU declaration of conformity, CE marking and registration proof, per system version.
Control and reassessment
Reassessment on substantial modification
Rerun the conformity route whenever the system is substantially modified.
Public tools
Full text of Article 43
The full legal text in the public AI Act Explorer.
Conditions and exceptions
- For most Annex III systems internal control suffices (Annex VI); a notified body is required for certain biometrics and where harmonised standards are lacking.
Official sources and locators
EU Artificial Intelligence Act 2024/1689
European Parliament and Council | original-oj-2024-07-12
Source locator: Articles 43, 47, 48 and 49
Digital Omnibus on AI 2026/1744
European Parliament and Council | official-journal-2026-07-24
Source locator: Amended Article 113 application dates
Version history
v1.0.0
27 July 2026
Articles 43-49: conformity assessment, CE and registration
The route from assessment to CE marking and EU database registration before market placement of high-risk AI.
Execution
From obligation to arranged and demonstrable
Knowing where you stand is step one. Embed AI translates this obligation into a concrete approach for your organisation: scope, ownership, register and evidence.
See the Embed AI approachFor AI agents and integrations
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