Conformity Assessment & CE Marking (EU / UK Aligned)
EU AI Act Compliance Conformity Assessment & CE Marking
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Key takeaways
- All high-risk AI systems must complete a conformity assessment before deployment or market placement.
- Internal Control (Annex VI) = self-certification for non-critical use; Full Quality Assurance (Annex VII) = third-party audit.
- CE or UKCA mark affixed only after Declaration of Conformity and technical file approval.
Overview & legal basis
The conformity assessment verifies that AI systems meet the EU AI Act’s essential requirements (Articles 9–15) and that documentation under Annex IV is complete and accurate.
Zen AI Governance applies the same process to UK deployments to achieve UKCA equivalence under the DSIT framework.
Assessment routes (Annex VI / VII)
| Route | When Applicable | Who Performs It | Output Document |
|---|
| Annex VI – Internal Control | System not safety-critical or uses standard modules | Organisation self-assessment | Internal Audit Report + DoC |
| Annex VII – Full Quality Assurance | High-impact systems or novel models processing sensitive data | Notified Body audit | Certificate of Conformity |
| Annex VIII – EU Declaration of Conformity | All systems seeking CE mark | Authorising Officer + Legal Team | Signed Declaration PDF |
Notified Body engagement
- Identify a designated Notified Body from the EU Commission NANDO database.
- Provide TDF, risk register, and quality manual for desktop review.
- Schedule Stage 1 (document review) and Stage 2 (onsite audit) activities.
- Close non-conformities with evidence (photos, logs, policies) before final certificate.
Documentation & evidence requirements
- Complete Technical Documentation File (TDF) as per Annex IV.
- Quality Management System manual (ISO/IEC 42001 sections 4–10).
- Risk Management File + post-market monitoring plan.
- Testing & validation records, model cards, and dataset logs.
- CE marking label design and traceability procedure.
Manufacturer: Zen AI Governance UK Ltd
Address: Sheffield, United Kingdom
Product: AI Governance Assistant Platform (v3.2)
Model Identifier: ZAI-AIG-0325
Conforms to: EU AI Act (Articles 9–15, Annex IV–VII); ISO/IEC 42001:2023
Assessment Route: Annex VII – Full Quality Assurance
Notified Body: NB 1234 – TÜV SÜD AI Systems
Issue Date: 2025-11-17
Authorising Officer: S. Masir, Director
Signature: __________________________
CE / UKCA marking rules
- Affix the mark on user interface splash screens and documentation only after DoC sign-off.
- Include Notified Body number for Annex VII audits (e.g., CE 1234).
- Maintain a registry of all marked systems with expiry and audit dates.
- UK deployments must carry UKCA mark and separate DoC file if placed on UK market.
Post-certification surveillance
- Annual surveillance audit by Notified Body (validates RMS updates & PMM data).
- Internal audit every six months per ISO/IEC 42001 §9.2.
- Report any major change (model update, dataset change, architecture modification) within 10 days.
A) Certification Register (CSV headers)
System_ID,Name,Version,Assessment_Route,Certificate_No,Issue_Date,Expiry_Date,Notified_Body,Status,EV_ID
B) Non-Conformity Report (Excerpt)
| ID | Description | Severity | Corrective Action | Status |
|---|
| NC-2025-07 | Missing bias testing log in TDF | Major | Submit bias report & training data summary | Closed |
Framework alignment
| Framework | Reference | Relevance |
|---|
| EU AI Act | Articles 43–51 & Annex VI–VIII | Defines conformity assessment routes and DoC requirements. |
| ISO/IEC 42001 | §9 & §10 | Audit management and improvement cycle. |
| NIST AI RMF | Manage & Govern | Evidence of trustworthiness controls. |
| UK DSIT Framework | Principle 6 | Proportional compliance and accountability review. |
Implementation checklist
- Assessment route selected (Annex VI or VII) and approved by Governance Board.
- Technical Documentation validated and filed under TDF repository.
- Notified Body contract signed; audit schedule confirmed.
- Declaration of Conformity signed and archived (DoC-ID).
- CE / UKCA mark applied; registry updated with expiry date.
- Surveillance audit plan logged in AIMS calendar.
© Zen AI Governance UK Ltd • Regulatory Knowledge • v1 17 Nov 2025 • This page is general guidance, not legal advice.
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