This is a ready-to-use technical documentation dossier matching Annex IV of the EU AI Act (Regulation (EU) 2024/1689), the minimum content a provider of a high-risk AI system must assemble under Article 11 before the system goes on the market and keep current across its lifecycle. It is built for a standalone Annex III high-risk system, an AI system in employment, biometric identification, or a similar listed use, that has no existing medical-device technical file to extend. If your AI is embedded in a combination product’s device constituent already going through MDR or IVDR conformity assessment, use the MDR/IVDR crosswalk instead, which extends your existing device file rather than duplicating it here. Replace every <<FILL: ...>> placeholder with your own specifics. A worked filled specimen excerpt follows the template. This is general guidance to adapt, not legal or regulatory advice; confirm the Act’s Annex IV text and every article citation against the current Official Journal version before you rely on this structure for a real submission.
Document control header
| Field | Entry |
|---|---|
| Dossier title | EU AI Act Technical Documentation: <<FILL: system name>> |
| Document number | <<FILL: DOSSIER-ID>> |
| Version | <<FILL>> |
| Date | <<FILL>> |
| Linked classification record | <<FILL: reference to the EU AI Act classification record confirming high-risk status and the Annex III route>> |
| Linked inventory entry | <<FILL: register System ID>> |
| Owner | <<FILL: AI Governance Lead / Regulatory Affairs>> |
| Kept current since | <<FILL: date first issued>> |
Purpose and scope
Article 11 requires a provider of a high-risk AI system to prepare technical documentation before the system is placed on the market or put into service, to keep it up to date throughout the system’s lifecycle, and to make it available to a national competent authority on request. Annex IV sets the minimum content, nine points, summarised below as nine sections. This dossier is a single, traceable file an assessor or an authority can read start to end; it is not a folder of unrelated documents referenced by hope.
1. General description of the AI system (Annex IV, point 1)
| Element | Entry |
|---|---|
| Intended purpose, provider name, version | <<FILL>> |
| How the system interacts with, or is used alongside, other hardware, software, or AI systems | <<FILL>> |
| Software and firmware versions, and update requirements | <<FILL>> |
| Form of distribution (embedded, downloadable, API, on-premises) | <<FILL>> |
| Hardware the system runs on or requires | <<FILL>> |
| External features, markings, and layout, if the system is a component of a product | <<FILL: or "not applicable" if the system is not a product component>> |
| Basic description of the user interface provided to the deployer | <<FILL>> |
| Instructions for use: intended purpose and how to deploy the system properly | <<FILL: reference the actual instructions-for-use document>> |
2. Detailed development description (Annex IV, point 2)
| Element | Entry |
|---|---|
| Development methods and the use of any third-party pre-trained system or component | <<FILL>> |
| Design specifications: architecture, algorithms, key design choices, and their rationale; optimisation objectives and trade-offs made | <<FILL>> |
| System architecture and the computational resources used to develop, train, test, and validate the system | <<FILL>> |
| Data requirements: datasheets describing training, validation, and test data, provenance, scope, main characteristics, how the data was obtained and selected, labelling procedures, and data cleaning methods | <<FILL: reference the data-governance record>> |
| Assessment of the human-oversight measures under Article 14, including the technical measures that support the human overseer | <<FILL>> |
| Pre-determined changes to the system and its performance, and the technical solutions used to keep the system compliant across those changes | <<FILL: or "none pre-determined" if not applicable>> |
| Validation and testing procedures: metrics used, test logs, and test reports, dated and signed by the responsible person | <<FILL: reference the validation protocol and report>> |
| Cybersecurity measures implemented | <<FILL>> |
3. Monitoring, functioning, and control (Annex IV, point 3)
Describe the system’s capabilities and limitations, including the degree of accuracy for specific persons or groups on which the system is intended to be used, and the overall expected accuracy against its intended purpose; the foreseeable unintended outcomes and sources of risk to health, safety, or fundamental rights, including possible discriminatory impact; the human-oversight measures needed, including the technical measures in place for a deployer to interpret the system’s output; and, where relevant, input data specifications or other information about the training, validation, and testing datasets.
<<FILL: narrative and any supporting figures>>
4. Appropriateness of the performance metrics (Annex IV, point 4)
State why the chosen metrics (accuracy, precision, recall, false-positive and false-negative rates, or whichever apply) are the appropriate measures for this system’s intended purpose, and how they were derived.
<<FILL>>
5. Risk management system (Annex IV, point 5)
A detailed description of the risk management system in accordance with Article 9: the identified and analysed risks, the risk estimation and evaluation, the mitigation measures adopted, and residual risk, across the system’s foreseeable lifecycle including foreseeable misuse. Where a GxP risk assessment already exists for this system, reference it and extend it with the AI-specific hazards (data drift, automation bias, adversarial input, training-data bias) rather than duplicating the whole file; see AI risk assessment in GxP for the underlying method.
<<FILL: reference the risk management file, or summarise inline>>
6. Lifecycle changes (Annex IV, point 6)
A log of relevant changes the provider has made to the system through its lifecycle: what changed, when, why, and the impact assessed.
| Date | Change | Reason | Impact assessed | Reference |
|---|---|---|---|---|
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
7. Standards applied (Annex IV, point 7)
| Requirement area | Harmonised standard applied, or alternative solution | How compliance is demonstrated |
|---|---|---|
| Risk management (Article 9) | <<FILL>> | <<FILL>> |
| Data governance (Article 10) | <<FILL>> | <<FILL>> |
| Technical documentation (Article 11) | This dossier | <<FILL>> |
| Record-keeping (Article 12) | <<FILL>> | <<FILL>> |
| Transparency to deployers (Article 13) | <<FILL>> | <<FILL>> |
| Human oversight (Article 14) | <<FILL>> | <<FILL>> |
| Accuracy, robustness, cybersecurity (Article 15) | <<FILL>> | <<FILL>> |
Where no harmonised standard yet exists for a requirement, describe the alternative solution used and the reasoning, since the Act’s harmonised standards were still maturing as of this writing; note that explicitly rather than leaving the row blank.
8. EU declaration of conformity (Annex IV, point 8)
A copy of the EU declaration of conformity referred to in Article 47.
<<FILL: attach or reference the signed declaration; if not yet issued, state target date>>
9. Post-market monitoring plan (Annex IV, point 9)
A description of the system in place to evaluate performance in the post-market phase in accordance with Article 72, including the post-market monitoring plan. Complete a full plan using the EU AI Act post-market monitoring plan template and reference it here; do not draft a second, inconsistent version inline.
| Field | Entry |
|---|---|
| Linked monitoring plan reference | <<FILL>> |
| Monitoring system live since | <<FILL: date>> |
Acceptance criteria
- All nine Annex IV points are present, each either completed inline or pointing to a named, retrievable supporting document.
- The dossier is linked to a classification record confirming the high-risk determination and route.
- Section 5 (risk management) and section 9 (post-market monitoring) are not blank placeholders; they reference live, maintained records.
- The dossier carries a version and date, and the lifecycle-changes log (section 6) is updated at each relevant change, not reconstructed retrospectively.
- The declaration of conformity is present or has a stated target date; a dossier without one is incomplete for market placement.
References
Regulation (EU) 2024/1689 (EU AI Act): Article 11 (technical documentation obligation) and Annex IV (minimum content); Article 9 (risk management system); Article 47 (EU declaration of conformity); Article 72 (post-market monitoring). Confirm the current Annex IV text, the harmonised standards published under Article 40, and any Commission implementing act against the current Official Journal and the Commission’s AI Act service desk before issue. The 2026 Digital Omnibus (Regulation (EU) 2026/1744, in force 27 July 2026) deferred the Annex III standalone high-risk application date to 2 December 2027; confirm the deadline applicable to your system’s classification and route before treating any date here as fixed.
Approvals
| Role | Name | Signature | Date |
|---|---|---|---|
| Author (AI Governance / Regulatory) | <<FILL>> | ||
| Reviewer (Quality) | <<FILL>> | ||
| Reviewer (Data Science) | <<FILL>> | ||
| Approver | <<FILL>> |
Filled specimen (excerpt)
Illustrative excerpt for an example employment-screening AI system used by an HR function (a genuine Annex III high-risk use, chosen because it has no device file to extend; company and system are fictitious).
| Section | Entry |
|---|---|
| System | Resume-and-assessment scoring tool ranking candidates for a technical role |
| Classification | High-risk, Annex III (employment and worker management) |
| Section 1, intended purpose | Ranks candidates by fit score from resume and structured assessment data; does not reject candidates automatically, a recruiter reviews every ranked list before any candidate is screened out |
| Section 3, monitoring and control | Expected accuracy against a held-out labelled set of 1,200 prior hiring decisions; known limitation: lower confidence for candidates with non-linear career histories; human-oversight measure is mandatory recruiter review before any adverse action |
| Section 5, risk management | Extends the existing HR-vendor risk file with AI-specific hazards: training-data bias against career gaps, automation bias in recruiter review, and adversarial resume optimisation; mitigation includes a quarterly bias audit by demographic group where lawfully collected |
| Section 9, post-market monitoring | Linked to plan PMM-AI-011: quarterly override-rate and demographic-outcome review, escalation to Legal and AI Governance if override rate exceeds threshold |
Common findings this dossier prevents
- Technical documentation assembled only after a request from an authority, rather than kept current from before market placement.
- A risk management section that restates the intended purpose instead of the required risk identification, estimation, and mitigation account under Article 9.
- No lifecycle-changes log, so a materially changed system cannot show what changed and when.
- The post-market monitoring plan drafted twice, once inline in the dossier and once as a separate document, with the two disagreeing.
- No declaration-of-conformity reference, leaving the file unable to demonstrate the system may lawfully be placed on the market.
How to adapt this dossier
- Confirm the classification record first; this structure applies once a system is confirmed high-risk via the Annex III route.
- Complete each of the nine sections; where a fuller document already exists (data governance record, validation report, risk file), reference it rather than duplicating its content here.
- Link section 9 to the standalone post-market monitoring plan so the two never diverge.
- Update the lifecycle-changes log at every relevant change, not in a retrospective reconstruction.
- Confirm Annex IV’s text, the Article 40 harmonised standards, and the applicable deadline against current sources before issue.