Complete conformity assessment, CE marking and EU database registration
Download: JSON · MarkdownUnder EU AI Act, Articles 43, 47, 48 and 49; Annex VIII
What this label means
- Verified
- — a named reviewer opened the official source and confirmed the record; the date and the reviewer are shown.
- Pending review
- — linked to the official source and in the queue for a reviewer to confirm.
- Source-linked
- — linked to the official source, not yet confirmed by a reviewer.
On this page 8 sections
In brief
Complete conformity assessment, CE marking and EU database registration is a legal requirement under the EU AI Act in the European Union (Articles 43, 47, 48 and 49; Annex VIII). It applies from 2 December 2027. The record carries 2 evidence examples and mappings to 1 framework.
- Instrument
- EU AI Act
- Jurisdiction
- European Union
- Nature
- Legal requirement
- Source reference
- Articles 43, 47, 48 and 49; Annex VIII
- Applies from
- 2 December 2027
- Who it binds
- Provider / developer, Deployer / user organisation, Public authority / government body
- Evidence examples
- 2
- Framework mappings
- ISO/IEC 42001:2023
- Controls that meet it
- 3
- Official source
- Open official text
- Verification
- Pending review · source-linked
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:
Which controls meet this duty?
Satisfies: the control, operated properly, does the work the duty asks for. Supports: it contributes but the duty needs more. Each control page lists every other duty it serves, so work done once can be counted once.
-
satisfiesProcessRegulatory compliance lead · once per ai systemConformity assessment, declaration and registration
Serves 4 recorded duties · evidence: Declaration of conformity or certificate, Registration record in the relevant database, Conformity evidence pack
Covers route selection, declaration, marking and database registration.
-
supportsPolicyQuality lead · annualQuality management system for AI development and supply
Serves 3 recorded duties · evidence: AI quality management system manual, Internal audit of the AI management system, Management review minutes
Internal-control assessment relies on the documented management system.
-
supportsProcessProduct or model owner · at launch and on material changeTechnical documentation, model cards and instructions for use
Serves 14 recorded duties · evidence: Technical documentation file, Model card or deployer information pack, Instructions for use
The technical file is the input to the assessment.
Templates that cover this duty
Generated from the records. Free · no account · links emailed to your work address. This duty is cited in each file with its source reference and a link back here.
- EU AI Act Role and Risk Classifier
Checklist · XLSX · v4
- EU AI Act Article 50 Transparency Kit
Kit · DOCX and XLSX · v32
- ISO/IEC 42001 Gap Assessment and Statement of Applicability
Assessment · XLSX · v3
- NIST AI RMF ↔ EU AI Act ↔ ISO/IEC 42001 Crosswalk
Crosswalk · XLSX · v3
What evidence would a reviewer expect?
| Evidence | Type | Notes |
|---|---|---|
| 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.
See every European Union duty mapped this way →
| 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 |
Frequently asked questions
Is this a legal requirement?
Yes. It is a legal requirement under EU AI Act (Articles 43, 47, 48 and 49; Annex VIII).
Who must comply with this obligation?
Providers of high-risk systems; public-authority deployers for registration.
When does this obligation apply?
It applies from 2 December 2027.
What evidence shows compliance?
A reviewer would expect: EU declaration of conformity; EU database registration record.
Which frameworks map to this obligation?
It is mapped to ISO/IEC 42001:2023 Clause 9 Performance evaluation; internal audit. These are editorial crosswalks with a stated confidence, not official mappings.
Which controls satisfy this obligation?
Conformity assessment, declaration and registration; Quality management system for AI development and supply; Technical documentation, model cards and instructions for use.
What should an organisation do in practice?
Determine the assessment route early; notified-body capacity may be limited around application dates.
Cite this record
AIPolicyTracker (2026). “Complete conformity assessment, CE marking and EU database registration (EU AI Act)” [AIPT-OBL-0014, not yet verified]. https://aipolicytracker.org/id/AIPT-OBL-0014 (accessed 27 October 2026). Data licensed CC BY 4.0.
Permanent id AIPT-OBL-0014: it never changes or gets reused, and its address keeps working if this page moves.
Cite the official text alongside it: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence, Official Journal of the European Union, https://eur-lex.europa.eu/eli/reg/2024/1689/oj.
BibTeX
@misc{aipolicytracker2026_completeconformityassess,
author = {{AIPolicyTracker}},
title = {{Complete conformity assessment, CE marking and EU database registration (EU AI Act)}},
year = {2026},
howpublished = {\url{https://aipolicytracker.org/obligations/eu-ai-act-conformity-assessment-registration}},
url = {https://aipolicytracker.org/obligations/eu-ai-act-conformity-assessment-registration},
urldate = {2026-10-27},
note = {Data licensed CC BY 4.0. Accessed 27 October 2026}
}
Change history
No change to this record's tracked fields has been recorded since 15 October 2026, when field-level history began.
Disclaimer: informational only, not legal advice. Verify every claim against the linked official sources and consult a qualified lawyer before acting.