T10 Technical Documentation Index and Conformity Checklist
Verification required. This is a working template, not a regulator-approved form. Where it cites an article or a date, the citation comes from secondary sources or from memory of the legal text and is a pointer to check. This is not legal advice.
How to use: This is a blank form. Copy it and fill in the empty cells and blanks for your system. To copy it, follow the "Suggest an edit to this page" link in the footer to reach its Markdown source.
For providers of high-risk systems. Wiki control: AI-CTRL-038. The Annex IV headings below are given from memory of its structure [Recalled]. Replace them with the exact Annex IV list from the Official Journal. This is a readiness index and does not amount to a conformity assessment. Some product-sector rules and the omnibus may change who must do what.
System ID: __ Version: _ Owner: Last updated: ___
1. Technical file index
| # | Section | Content to include | Location / link | Owner | Status |
|---|---|---|---|---|---|
| 1 | General description | Intended purpose, provider, version history, hardware and software context, forms of placing on the market, instructions for use | |||
| 2 | Development process | Design choices, architecture, algorithms and key choices, data requirements, training methods, optimisation, human oversight measures, pre-determined changes | |||
| 3 | Monitoring, functioning and control | Capabilities and limits, accuracy levels and expected errors for groups, foreseeable misuse and risks to health, safety and rights, oversight measures, input data specification | |||
| 4 | Performance metrics | Why chosen, declared values | |||
| 5 | Risk management system | Process, identified risks, mitigations, residual risk acceptance | |||
| 6 | Lifecycle changes | Relevant changes by the provider | |||
| 7 | Standards and specifications applied | Harmonised or other; where none, the solutions adopted | |||
| 8 | Declaration of conformity | Copy | |||
| 9 | Post-market monitoring plan | Plan and data collection |
2. Data governance record
| Item | Entry |
|---|---|
| Training, validation and test datasets: origin, scope, characteristics | |
| Collection and preparation steps | |
| Assumptions made | |
| Suitability assessment, availability, quantity | |
| Bias examination and mitigation (AI-CTRL-041) | |
| Gaps and how they were addressed | |
| Special category data use and necessity record | |
| Copyright and licence position |
3. Logging design
Wiki control: AI-CTRL-008.
| Item | Entry |
|---|---|
| Events logged | |
| Fields (time, input reference, model version, output, reviewer action) | |
| Retention | |
| Access control | |
| Ability to reconstruct a decision |
4. Human oversight design (Art. 14 themes)
| Question | Answer |
|---|---|
| What can the overseer see and understand? | |
| How is automation bias addressed? | |
| Can they override, reverse or stop? | |
| Who is competent and trained? | |
| Is there a safe stop procedure? | |
| Evidence of use in practice |
5. Accuracy, robustness, cybersecurity
| Item | Entry |
|---|---|
| Metrics and results | |
| Error handling | |
| Feedback-loop controls | |
| Resilience to poisoning, adversarial examples, model evasion and confidentiality attacks | |
| Test reports |
6. Quality management system
Procedures to hold: design and verification, data management, risk management, post-market monitoring, incident reporting, communication with authorities, record keeping, resource management, accountability framework.
Standard followed: ______. EN 18286:2026 is reported as approved, with its OJ citation pending [Reported].
7. Conformity route
| Item | Entry |
|---|---|
| Route (internal control or notified body, per Annex and sector) | |
| Notified body (if any) and certificate | |
| Declaration of conformity date | |
| CE marking applied | |
| EU database registration reference | |
| Authorised representative (non-EU) | |
| Instructions for use delivered to deployers |
8. Deployer pack contents
Intended purpose, accuracy and limits, oversight measures, input data guidance, log access, maintenance, expected lifetime, and how to run a FRIA or DPIA.
9. Sign-off
| Role | Name | Date |
|---|---|---|
| Provider representative | ||
| Independent reviewer |