Complete conformity assessment, CE marking and EU database registration
Under EU AI Act, Articles 43, 47, 48 and 49; Annex VIII
What does it require?
Before placing a high-risk system on the market, providers must complete the applicable conformity assessment (internal control or notified-body assessment depending on the system), draw up an EU declaration of conformity, affix the CE marking, and register the system in the EU database. Deployers that are public authorities must also register their use of Annex III systems.
Practical action
Determine the assessment route early; notified-body capacity may be limited around application dates.
Who does it apply to?
Providers of high-risk systems; public-authority deployers for registration.
- Sectors
- Cross-sector / all sectors
Applies from:
Evidence examples
- EU declaration of conformity (document)
- EU database registration record (record)
Framework mappings
Original editorial crosswalks. They cite clause numbers only and reproduce no standard text; confidence reflects how direct the mapping is.
| Framework | Reference | Note | Confidence |
|---|---|---|---|
| ISO/IEC 42001:2023 | Clause 9 Performance evaluation; internal audit | Original editorial mapping; not a substitute for legal conformity assessment. | low |
Informational only, not legal advice. Verify every claim against the linked official sources and consult qualified counsel before acting.