Comprehensive technical documentation for market surveillance authorities — Article 11 / Annex IV of Regulation (EU) 2024/1689
General description required by Annex IV(1) — to be drawn up before placement on market and kept up to date
Annex IV(2) — detailed description of system elements and development process
Annex IV(2)(g) — validation and testing procedures, metrics, test logs
| Metric | Threshold | Achieved | Test Method | Date | Status |
|---|---|---|---|---|---|
| {{METRIC_NAME}} | {{METRIC_THRESHOLD}} | {{METRIC_ACHIEVED}} | {{METRIC_TEST_METHOD}} | {{METRIC_DATE}} | {{METRIC_STATUS}} |
| Protected Attribute | Test Method | Result | Action Taken |
|---|---|---|---|
| {{DISC_ATTRIBUTE}} | {{DISC_TEST_METHOD}} | {{DISC_RESULT}} | {{DISC_ACTION}} |
Annex IV(4) — applied harmonised standards, common specifications, and other standards
| Standard / Specification | Reference | Scope | Fully Applied? | Derogation Justification |
|---|---|---|---|---|
| {{STD_NAME}} | {{STD_REFERENCE}} | {{STD_SCOPE}} | {{STD_APPLIED}} | {{STD_DEROGATION}} |
Annex IV(9) — description of post-market monitoring system per Art. 72
Annex IV(7) — predetermined changes, updates, and compliance implications
| Version | Date | Change Description | Substantial Modification? | Conformity Re-Assessment Required? |
|---|---|---|---|---|
| {{CHG_VERSION}} | {{CHG_DATE}} | {{CHG_DESCRIPTION}} | {{CHG_SUBSTANTIAL}} | {{CHG_REASSESSMENT}} |
This document is generated by HAIEC (Holistic AI Ethics & Compliance) based on responses provided through the HAIEC EU AI Act compliance wizard. It does not constitute legal advice, a legal opinion, or a certification of compliance with Regulation (EU) 2024/1689. It has not been reviewed by a notified body, qualified legal counsel, or any competent authority. HAIEC's compliance assessment engine is deterministic — no AI model was used to generate compliance conclusions. All scoring and gap analysis is produced by rules-based logic mapped to Regulation (EU) 2024/1689 as published in the Official Journal (OJ L, 12 July 2024).