Evidence TemplatesEU AI Act

EU AI Act Technical Documentation and Provider Evidence Templates

A practical evidence structure for providers of high-risk AI systems under Article 11, Annex IV, and Article 16 of Regulation (EU) 2024/1689.

Use it to organize technical documentation, quality management records, logs, conformity assessment proof, EU declaration of conformity, CE marking, registration, and post-market monitoring evidence.

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Author
Sorena AI
Published
May 9, 2026
Updated
May 9, 2026
Sections
5

Structured answer sets in this page tree.

Primary sources
8

Cited legal and guidance references.

Publication metadata
Sorena AI
Published May 9, 2026
Updated May 9, 2026
Overview

This page turns the EU AI Act provider evidence package into concrete templates. It is written for teams preparing or maintaining high-risk AI system documentation, not for general AI policy tracking. The core record is the Article 11 technical file, supported by Annex IV content, Article 16 provider-obligation evidence, quality management records, logs, conformity assessment outputs, registration data, and the Article 72 post-market monitoring plan.

Section 1

Template 1: Article 11 and Annex IV technical documentation file

Article 11 requires technical documentation for a high-risk AI system to be drawn up before the system is placed on the market or put into service, kept up to date, and written clearly enough for competent authorities and notified bodies to assess compliance.

The Annex IV template should be maintained as a controlled technical file, with one owner for each field and a direct link to the underlying proof. Avoid a narrative-only document: auditors and notified bodies need traceability from claim, to system version, to test result, to approval.

  • System identity: intended purpose, provider name, version history, release form, hardware or software dependencies, user interface, and instructions for deployers.
  • Design and development: development methods, third-party or pre-trained components, architecture, design choices, assumptions, optimization targets, expected outputs, and known trade-offs.
  • Data evidence: training, validation, and testing data descriptions, provenance, selection, labelling, cleaning, representativeness, data gaps, bias checks, and mitigation records.
  • Testing evidence: validation procedures, metrics for accuracy, robustness, cybersecurity, discrimination impacts, dated and signed test logs, and all test reports.
  • Control evidence: human oversight measures, input-data specifications, risk management record, cybersecurity measures, relevant lifecycle changes, standards or specifications used, and the EU declaration of conformity.
  • Post-market evidence: the system used to evaluate performance after market placement, including the Article 72 post-market monitoring plan.
Sources for this answer
Regulation (EU) 2024/1689 - Article 11 and Annex IV
Supports the requirement to create and maintain technical documentation for high-risk AI systems and the minimum Annex IV content categories.
Section 2

Template 2: Article 16 provider-obligation evidence register

Article 16 is the provider evidence checklist for high-risk AI systems. The register should show that each provider duty has an accountable owner, a maintained artifact, a date of last review, and a release gate that prevents market placement or putting into service before required evidence exists.

Use the register as the table of contents for the compliance file. It should not duplicate every technical detail; it should point to the authoritative record for each Article 16 obligation.

  • Compliance gate: proof that the system meets the Chapter III, Section 2 requirements before release.
  • Provider identification: name, trade name or trademark, and contact address on the system, packaging, or accompanying documentation where applicable.
  • Quality management: Article 17 quality management system procedure, scope, management responsibility, and modification-control records.
  • Documentation retention: Article 18 evidence showing technical documentation, QMS documentation, notified-body decisions, certificates, and EU declarations are kept for the required authority-access period.
  • Log custody: Article 19 evidence showing which automatically generated logs are under provider control, retention logic, access controls, and authority-response procedure.
  • Conformity package: conformity assessment record, EU declaration of conformity, CE marking decision, registration record, corrective-action procedure, authority-response pack, and accessibility compliance evidence.
Sources for this answer
Regulation (EU) 2024/1689 - Article 16
Lists the provider obligations for high-risk AI systems, including QMS, documentation, logs, conformity assessment, declaration, CE marking, registration, corrective actions, and authority cooperation.
Section 3

Template 3: quality management, conformity, CE marking, and registration pack

The AI Act evidence pack should connect the management system to the product-law outputs. Article 17 requires documented policies, procedures, and instructions; Articles 47 to 49 convert that operating system into declaration, marking, and registration records.

For high-risk AI systems that require notified-body involvement, keep the notified-body application, technical documentation submitted, assessment decision, certificate, change notifications, audit reports, and any additional tests or evidence requests together with the same system version.

  • Quality management fields: regulatory strategy, design control, development and validation procedures, data management, risk management, post-market monitoring, serious-incident reporting, authority communication, record-keeping, resources, and management accountability.
  • EU declaration fields: system name and traceable identifier, provider or authorised representative, sole-responsibility statement, conformity statement, applicable Union law, standards or common specifications, notified-body details where applicable, place, date, signatory, and signature.
  • CE marking fields: placement of the marking, digital access path where the system is provided digitally, notified-body identification number where applicable, and promotional-material checks when CE conformity is mentioned.
  • Registration fields: provider and authorised-representative details, AI system trade name, intended purpose, operating logic summary, market status, certificate details where applicable, Member States, EU declaration copy, electronic instructions for use, and optional additional-information URL.
  • Change-control fields: intended changes, affected documentation sections, standards impact, notified-body notification need, conformity reassessment decision, and release approval.
Sources for this answer
Regulation (EU) 2024/1689 - Articles 17, 47, 48, 49 and Annexes V, VII, VIII
Supports the quality management system, EU declaration of conformity, CE marking, conformity assessment, and registration fields.
AI Act Service Desk - Article 49 registration
Explains registration of providers, authorised representatives, deployers, and high-risk AI systems in the EU database before placement or use.
Section 4

Template 4: logs, post-market monitoring, and corrective-action evidence

The evidence file should not stop at release. Article 12 requires high-risk AI systems to technically allow automatic event recording, Article 19 requires providers to keep logs under their control, and Article 72 requires active post-market monitoring throughout the system lifetime.

The post-market template should make field data usable. It should identify what is collected, who reviews it, which signals trigger investigation, how deployer feedback is handled, and how the technical documentation is updated when performance, risk, or intended use changes.

  • Logging template: event category, timestamp, system version, deployment context, risk signal, substantial-modification indicator, deployer-control boundary, retention period, access owner, and authority-disclosure workflow.
  • Monitoring plan: sources of performance data, deployer feedback channels, incident intake, sampling method, review cadence, acceptance thresholds, interaction with other AI systems, and documentation update trigger.
  • Corrective-action record: non-conformity or risk description, cause investigation, affected versions and deployers, corrective action, withdrawal, disabling or recall decision, authority and notified-body notifications where applicable, and closure evidence.
  • Documentation update trigger: model, data, interface, intended-purpose, performance, cybersecurity, human-oversight, integration, or deployment-context change that affects compliance or the technical file.
Sources for this answer
Regulation (EU) 2024/1689 - Articles 12, 19, 20, 21 and 72
Supports log capability, provider log retention, corrective actions, authority cooperation, and post-market monitoring plan requirements.
Section 5

Optional add-on: GPAI model provider documentation templates

If the evidence package also covers a general-purpose AI model provider, keep that record separate from the high-risk AI system technical file. GPAI providers have model documentation and downstream-provider information duties under Article 53, with minimum content in Annexes XI and XII.

For GPAI models, add a public summary of training content using the Commission template where Article 53(1)(d) applies. Do not merge that public summary with confidential technical documentation; the audiences and disclosure levels are different.

  • GPAI model documentation: tasks, acceptable-use policies, release date, distribution method, architecture, parameters, modality, licence, training and validation information, compute, training time, and energy-consumption information where applicable.
  • Downstream-provider information: capabilities, limitations, integration requirements, acceptable uses, software versions, and other information needed by system providers to understand and comply with their own AI Act obligations.
  • Training-content summary: public categories of training content, explanation of unavailable information where justified, update date, and a clear distinction between public summary fields and confidential technical file fields.
Sources for this answer
European Commission - Guidelines for providers of general-purpose AI models
Commission guidance context for GPAI provider obligations, submission routes, and how the Commission interprets the GPAI provider scope.
European Commission - Template for GPAI training-content summaries
Supports the public training-content summary template for general-purpose AI model providers under Article 53(1)(d).
Recommended next step

Build provider evidence that survives release, audit, and authority questions

Sorena can help structure Article 11 technical files, Article 16 provider evidence registers, conformity records, EU database registration fields, log-retention evidence, and post-market monitoring plans around the source-linked requirements on this page.

Research workflow
Open Research Copilot for EU AI Act

Ask source-linked questions about technical documentation, provider duties, conformity assessment, registration, and post-market monitoring using the cited AI Act sources.

Explore next step
Talk to Sorena
Talk through implementation

Review your high-risk AI system evidence templates, GPAI documentation boundaries, source gaps, and next implementation steps with Sorena.

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Primary sources

References and citations

AI Act Service Desk - Article 49 registration
ai-act-service-desk.ec.europa.eu
Referenced sections
  • Explains registration of providers, authorised representatives, deployers, and high-risk AI systems in the EU database before placement or use.
"registration requirements for high-risk AI systems"
Regulation (EU) 2024/1689 - Article 11 and Annex IV
eur-lex.europa.eu
Referenced sections
  • Supports the requirement to create and maintain technical documentation for high-risk AI systems and the minimum Annex IV content categories.
"The technical documentation shall contain at least the following information"
Regulation (EU) 2024/1689 - Article 16
eur-lex.europa.eu
Referenced sections
  • Lists the provider obligations for high-risk AI systems, including QMS, documentation, logs, conformity assessment, declaration, CE marking, registration, corrective actions, and authority cooperation.
"Providers of high-risk AI systems shall"
Regulation (EU) 2024/1689 - Articles 12, 19, 20, 21 and 72
eur-lex.europa.eu
Referenced sections
  • Supports log capability, provider log retention, corrective actions, authority cooperation, and post-market monitoring plan requirements.
"actively and systematically collect, document and analyse relevant data"
Regulation (EU) 2024/1689 - Artificial Intelligence Act
eur-lex.europa.eu
Referenced sections
  • Primary legal source for Article 11 technical documentation, Annex IV technical-file fields, Article 16 provider obligations, quality management, logs, conformity, CE marking, registration, and post-market monitoring.
"laying down harmonised rules on artificial intelligence"
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