SkarpChapter 25 of 25
Annexes VII–XIII: Operational Compliance and the Act as a Whole
The final annexes supply the operational detail for notified-body assessment, registration, real-world testing, transitional IT systems and general-purpose AI documentation. Together they consolidate the Act as a complete chain from classification and evidence to market access, deployment, monitoring and enforcement.
The Operational Chain Across Annexes VII-XIII
A compliance pipeline
Annexes VII-XIII connect evidence, assessment, registration, real-world testing, model documentation, and systemic-risk designation.
Read the annexes as roles
Providers document and register. Notified bodies assess and audit. Deployers submit impact-assessment summaries. The Commission considers systemic-risk criteria.
Scope discipline
Teach each annex as written. A cross-reference to an Article signals context, but this text does not reproduce every obligation in that Article.
Annex VII, Points 1-3: Quality Management System Assessment
Two linked assessments
Annex VII defines a procedure based on assessment of both the quality management system and the technical documentation.
Application contents
Point 3.1 requires identity details, covered-system list, technical documentation, Article 17 documentation, adequacy procedures, and a no-duplicate-application declaration.
Approval is not permanent silence
The provider shall maintain the approved system. Intended changes to it or its covered-system list shall be disclosed for examination and, if needed, reassessment.
Worked Example: One Quality System, Several AI Systems
Scenario
A provider uses one quality management system for three AI systems. The application must still include technical documentation for each AI system covered.
Adding a fourth system
Adding an AI system changes the covered-system list. The provider shall notify the notified body, which decides whether reassessment is necessary.
Key distinction
The provider supplies and maintains evidence. The notified body assesses the quality system and issues a reasoned decision. Technical documentation remains separately assessed.
Quiz: Annex VII Quality Management Changes
Choose the answer that follows Annex VII point 3.4 exactly.
A provider plans to add another AI system to the list covered by its approved quality management system. What does Annex VII point 3.4 require first?
- Bring the intended change to the attention of the notified body.
- Apply automatically for a completely new certificate.
- Wait until the next periodic audit before disclosing the change.
- Register the change only in the EU database.
Show Answer
Answer: A) Bring the intended change to the attention of the notified body.
Point 3.4 says that any intended change to the approved quality management system or the covered AI-system list shall be brought to the notified body's attention. The notified body then decides whether the modified system still satisfies requirements or reassessment is necessary.
Annex VII, Point 4: Technical Documentation, Data, Models, and Certificates
Technical-documentation application
Point 4.2 requires provider details, a declaration that no identical application was lodged elsewhere, and the technical documentation referred to in Annex IV.
Data access is mandatory when relevant
Where relevant and necessary, the notified body shall receive full access to training, validation, and testing data sets, including remote access where appropriate.
Model access has conditions
Access to training and trained models follows only after other reasonable verification means are exhausted and insufficient, and after a reasoned request.
Certificates and retraining
Conformity leads to a Union technical documentation assessment certificate. Training-data non-compliance means re-training will be needed before a new assessment application.
Annex VII, Points 4.7 and 5: Change Assessment and Surveillance
System changes
A change that could affect compliance or intended purpose shall be assessed by the notified body that issued the certificate. The provider shall inform that body.
Two possible routes
The notified body decides between a new conformity assessment under Article 43(4) and a supplement to the existing certificate.
Surveillance in practice
The provider shall permit premises access and share necessary information. Periodic audits check that the approved quality management system is still maintained and applied.
Annex VIII: Registering High-Risk Systems and Impact-Assessment Summaries
Section A: provider registration
Providers submit and keep current identity details, intended purpose, operating logic, market status, market locations, conformity documentation, and specified certificate information.
Traceability and status
The record requires a trade name plus an unambiguous traceability reference, and the system status: market/service, no longer placed/in service, or recalled.
Sections B and C
Section B records the Article 6(3) basis for not-high-risk status. Section C requires deployers to submit summaries of fundamental-rights and applicable data-protection impact assessments.
External currency note
A July 8, 2026 signed-but-not-yet-in-force amendment would delete Section B points 7 and 9. The supplied original text remains applicable today.
Annex IX and Annex X: Real-World Test Records and EU IT-System Context
A test-specific registration record
Annex IX requires a Union-wide unique test identifier, participant contacts, system identification, a testing-plan summary, and suspension or termination information.
Annex X is a legislative list
Annex X lists major EU systems including SIS, VIS, Eurodac, EES, ETIAS, ECRIS-TCN, and the two interoperability Regulations.
External currency note
A July 8, 2026 pending amendment expands Article 60 testing scope and adds Article 60a, but does not amend Annex IX. It is not in force today.
Worked Example: Documenting a General-Purpose AI Model Under Annex XI
Proportionate, but not optional
Annex XI Section 1 documentation shall contain at least the listed information, as appropriate to the general-purpose model's size and risk profile.
Describe the model
Document tasks, compatible AI systems, acceptable-use policies, release and distribution, architecture and parameter count, input/output modality and format, and licence.
Describe development
Document integration means, design specifications, training methods, assumptions, optimisation goals, data provenance and curation, compute, training time, and energy.
Unknown energy use
Where model energy consumption is unknown, Annex XI says it may be based on information about computational resources used.
Annex XI Section 2 and Annex XII: Systemic-Risk Evidence and Downstream Transparency
Systemic-risk evaluation evidence
Evaluation strategies include results, criteria, metrics, and methods for identifying limitations. This is more than naming a benchmark.
Adversarial testing
Where applicable, systemic-risk documentation includes measures for internal or external adversarial testing, such as red teaming, and model adaptations.
Downstream integration
Annex XII gives downstream providers practical integration information: tools, infrastructure, instructions, software versions where applicable, input/output formats, and maximum sizes.
Sort the Evidence: Provider File, Downstream File, or Systemic-Risk File?
Thought exercise
For each item, decide where the supplied text places it. Write your answer before checking.
- A description of the maximum context-window length for inputs and outputs.
- Evaluation criteria, metrics, and a methodology for identifying model limitations.
- A scanned copy of a notified-body certificate for a registered high-risk AI system.
- Information on the suspension or termination of a real-world test.
- A description of how software components build into one another across the overall processing system.
Self-check
- Annex XII: downstream transparency information includes input/output modality, format, and maximum size.
- Annex XI Section 2: systemic-risk evaluation strategies include criteria, metrics, and limitation-identification methodology.
- Annex VIII Section A: where applicable, registration includes a scanned certificate copy.
- Annex IX: the real-world testing record includes suspension or termination information.
- Annex XI Section 2: where applicable, systemic-risk providers provide a detailed system-architecture description.
The lesson is functional: similar information may appear in several annexes, but the required recipient and compliance purpose differ.
Quiz: Annex XIII Systemic-Risk Criteria
Select the precise market-reach presumption stated in Annex XIII.
When does Annex XIII say high impact on the internal market due to reach shall be presumed?
- When the model has at least 10,000 registered business users established in the Union.
- When the model has 10,000 registered end-users anywhere in the world.
- When the model has one million total downloads.
- When the model is available in at least 10 Member States.
Show Answer
Answer: A) When the model has at least 10,000 registered business users established in the Union.
Annex XIII point (f) says high impact due to reach shall be presumed when the model has been made available to at least 10,000 registered business users established in the Union. Point (g) separately identifies the number of registered end-users as a criterion.
Flashcards: Operational Compliance Recall
Flip each card and explain why the term matters within Annexes VII-XIII.
- Annex VII conformity procedure
- It is based on assessment of the quality management system and assessment of technical documentation under points 2 to 5.
- Notified-body data access
- Where relevant and necessary, the notified body shall be granted full access to training, validation, and testing data sets used, with appropriate security safeguards.
- Model access under Annex VII
- After other reasonable verification means are exhausted and insufficient, and upon a reasoned request, access to training and trained models, including relevant parameters, shall also be granted.
- Training-data non-compliance
- Re-training of the AI system will be needed prior to applying for a new conformity assessment.
- Annex VIII Section C
- Deployers provide the provider's EU-database entry URL and summaries of fundamental-rights and, where applicable, data-protection impact assessments.
- Annex IX identifier
- A Union-wide unique single identification number of the testing in real world conditions.
- Annex XII maximum-size information
- It covers modality and format of inputs and outputs and their maximum size, for example context-window length.
- Annex XIII market-reach presumption
- High internal-market impact due to reach shall be presumed at at least 10,000 registered business users established in the Union.
Key Terms
- red teaming
- An example of internal and/or external adversarial testing addressed in Annex XI Section 2 where applicable.
- notified body
- The body that assesses the quality management system and technical documentation, may require evidence or tests, issues or refuses the Union technical documentation assessment certificate, and carries out surveillance.
- systemic risk
- A designation considered under Annex XIII using parameters, data, training compute, modalities, evaluations, reach, and end-user information.
- real-world testing
- Testing registered under Annex IX, identified through a Union-wide unique single identification number and accompanied by participant, system, plan, and status information.
- registered end-users
- The number of registered end-users is a separate Annex XIII criterion for systemic-risk designation.
- conformity assessment
- In Annex VII, the procedure based on assessment of the provider's quality management system and assessment of technical documentation.
- general-purpose AI model
- A model for which Annex XI requires technical documentation and Annex XII requires specified transparency information for downstream providers.
- authorised representative
- A person whose name, address, and contact details are included where applicable in Annex VII applications and Annex VIII registrations.
- registered business users
- Business users established in the Union; reaching at least 10,000 creates Annex XIII's presumption of high internal-market impact due to reach.
- Union technical documentation assessment certificate
- The certificate the notified body shall issue when the AI system conforms with Chapter III, Section 2 requirements.