Artifact GuideEU

EU Cyber Resilience Act Article 31 and Annex VII Technical Documentation and Audit File

A structure based on official sources for the technical documentation manufacturers need before placing a product with digital elements on the EU market.

Use it to connect product scope, cybersecurity risk assessment, Annex I requirement mapping, vulnerability handling, conformity assessment, and retained evidence.

Author
Sorena AI
Published
Mar 4, 2026
Updated
Jul 31, 2026
Sections
6

Structured answer sets in this page tree.

Primary sources
3

Cited legal and guidance references.

Publication metadata
Sorena AI
Published Mar 4, 2026
Updated Jul 31, 2026
Overview

The CRA requires ; "audit file" is an internal label for organising it. The file shows how a product with digital elements, and the manufacturer's vulnerability-handling processes, meet the essential cybersecurity requirements. Article 31 requires the manufacturer to prepare it before market placement and update it continuously where appropriate, at least during the . Annex VII sets the minimum contents.

Section 1

Annex VII contents to index first

Treat Annex VII as the table of contents for the CRA technical file. The record must identify the product, show the versions that affect cybersecurity conformity, explain the intended purpose, and include the user information and instructions required by Annex II.

For hardware products, Annex VII also requires photographs or illustrations that show external features, marking, and internal layout. For software and connected products, the same section should clearly identify release lines, in-scope remote data processing, and the product boundary used for the risk assessment.

  • Product description, intended purpose, affected software versions, user instructions, and marking evidence
  • Architecture material showing how software components build on or feed into each other and integrate into the overall processing
  • Design, development, production, monitoring, and validation evidence for the product and its cybersecurity controls
  • The EU declaration of conformity; the within the vulnerability-handling process description; and, where applicable, the SBOM supplied after a market surveillance authority makes a reasoned request and needs it to check Annex I compliance
Section 2

Risk assessment and Annex I traceability

The audit file must show the cybersecurity risks against which the product is designed, developed, produced, delivered, and maintained, then explain how each applicable Annex I Part I requirement is implemented.

The Commission FAQ clarifies that the cybersecurity risk assessment covers the whole product with digital elements, including remote data processing when in scope, and supports planning, design, development, production, delivery, and maintenance. Keep the assessment tied to intended purpose, reasonably foreseeable use, conditions of use, and the time the product is expected to be in use. Article 13 also requires the manufacturer to document later cybersecurity information proportionately and update the risk assessment where applicable.

  • Map each applicable Annex I Part I control to the risk it treats, the implemented design measure, and the test or review evidence
  • Record why any Annex I Part I requirement is not applicable to the product or a specific release line
  • Include support-period inputs required by Annex VII, such as expected use, security-update assumptions, and vulnerability-handling capacity
  • Keep residual cybersecurity risks, accepted constraints, and mitigations connected to release approvals instead of leaving them in separate security review notes
Section 3

Vulnerability handling and update evidence

Annex VII makes vulnerability handling part of the , not a separate security operations appendix. The record must include the , coordinated vulnerability disclosure policy, evidence of a vulnerability reporting contact address, and the technical solution chosen for secure update distribution.

Annex I Part II adds the operating evidence: identified and documented vulnerabilities and components, remediation and security updates, regular tests and reviews, fixed-vulnerability disclosures, coordinated disclosure, vulnerability reporting channels, secure update distribution, and advisory messages for users.

  • Keep component inventory and evidence aligned with the product versions listed in the technical file
  • Store vulnerability intake, triage, remediation, fixed-vulnerability disclosure, and user-advisory records against the affected product version
  • Separate security-update evidence from feature-update evidence where the product architecture and release process allow it
  • Tie Article 14 actively exploited vulnerability or severe incident notifications, when relevant, to the same product and vulnerability records
Section 4

Control versions, updates, and document language

The current file must identify every software version that affects compliance, while the history preserves what changed, how each version was identified, and which conformity evidence applied. Update the documentation when product changes, tests, reported vulnerabilities, third-party information, or support-period decisions change the compliance evidence.

Article 31 requires and conformity-assessment correspondence in an official language of the Member State where the notified body is established or another language acceptable to that body. A market surveillance authority can separately require the information in a language it can easily understand. Record both language decisions when a notified body and an authority are involved.

  • Version register: product model, software branch, build, release date, market status, support status, and linked declaration or certificate
  • Change assessment: affected Annex I requirements, cybersecurity risk change, tests repeated, technical-file sections updated, and conformity-route escalation
  • Document control: owner, approver, effective date, superseded version, change reason, approved language, retention class, and retrieval location
  • Authority response pack: exact request, legal entity, requested language, confidentiality marking, documents supplied, transmission record, and follow-up
  • Reassessment triggers: changed intended purpose, product functions, software affecting conformity, architecture, remote processing, components, vulnerabilities, , standards, classification, or conformity route
Section 5

Conformity assessment and authority-ready records

Article 32 and Annex VIII determine how the file is used in . Under Module A, the manufacturer draws up the Annex VII and declares conformity on its own responsibility. Under Module B+C or Module H, notified-body material such as applications, certificates, evaluation reports, quality-system approvals, surveillance records, and vulnerability-handling audit records should sit beside the same Annex VII evidence. Module H still requires technical documentation for one model of each product category covered by the quality-system application.

Annex VIII requires the EU declaration of conformity and to be kept at the disposal of national authorities for 10 years after the product is placed on the market or for the , whichever is longer. The Commission FAQ also notes that market surveillance authorities may request the documentation and that it must be comprehensive and clear.

  • Record the conformity route used for the product: Module A, Module B+C, Module H, or an applicable European cybersecurity certification route
  • Keep test reports showing conformity of both the product and vulnerability-handling processes with Annex I Parts I and II
  • Preserve standards, common specifications, certification schemes, and alternative technical specifications with the exact parts applied
  • Maintain a retrieval pack containing the current technical file, historical release evidence, declaration of conformity, authority correspondence, and notified-body records where applicable
Section 6

Combine files only where the CRA permits it

Article 31(3) requires one technical-documentation set for a product covered by CRA Article 12 and other Union acts that also require . The combined file must contain both Annex VII material and the information required under the other acts; combining files does not remove either set of requirements.

For other products subject to several Union acts, coordinate the technical file and the single EU declaration of conformity required by Article 28, but verify the document rules in each applicable act. Keep act-specific assessments identifiable so an authority or notified body can see which evidence supports each legal requirement.

  • List every applicable Union act and the product facts that trigger it
  • Map shared evidence once and identify any act-specific tests, risk assessments, language rules, or retention periods
  • Keep the single EU declaration aligned with every applicable act and its publication reference
Recommended next step

Keep CRA technical documentation and audit evidence in one governed system

This CRA technical-documentation structure helps centralize product scope, risk assessment, Annex I mapping, vulnerability-handling evidence, conformity records, and authority-ready retention.

Primary sources

References and citations

ec.europa.eu
Referenced sections
  • Supports the page guidance that technical documentation may be requested by market surveillance authorities, should be comprehensive and clear, and must demonstrate design, development, manufacturing, and vulnerability-handling conformity.
"not only an internal deliverable"
eur-lex.europa.eu
Referenced sections
  • Supports the Article 31 duty to draw up and update technical documentation, Annex VII minimum file contents, Annex I cybersecurity and vulnerability-handling evidence, and Annex VIII conformity-assessment records.
"The technical documentation shall contain all relevant data or details"
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