Artificial Intelligence Policy Tracker
Legal requirement Conformity assessment and registration European Union Partially applicable

Complete conformity assessment, CE marking and EU database registration

Download: JSON · MarkdownUnder EU AI Act, Articles 43, 47, 48 and 49; Annex VIII

Pending review · linked to the official source, waiting for a reviewer to confirm it (a factual check against the official source, not a legal review or legal advice)
What this label means
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— 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.
Verification policy and current standing · a factual check, not legal advice.
No change recorded as of 26 Sep 2026 · official source last checked
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.

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 system
    Conformity 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 · annual
    Quality 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 change
    Technical 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.

All 8 templates that cover it →

What evidence would a reviewer expect?

Evidence examples
EvidenceTypeNotes
EU declaration of conformitydocument
EU database registration recordrecord

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 mappings table
FrameworkReferenceNoteConfidence
ISO/IEC 42001:2023Clause 9 Performance evaluation; internal auditOriginal 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.