Artifact GuideEU

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

A structure based on official sources for the 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, , and retained evidence.

Author
Sorena AI
Published
Mar 4, 2026
Updated
Oct 15, 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

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"
Show all related guides (55)

CRA Products with Digital Elements Scope | EU Cyber Resilience Act

Apply the EU Cyber Resilience Act scope test for software, hardware, remote data processing, components, open-source software, exclusions, and economic-operator roles.

CRA Requirements | Annex I, Manufacturer Duties and CE Evidence

Map Cyber Resilience Act requirements from Annex I to manufacturer duties, vulnerability handling, user information, technical documentation, declaration of conformity, and CE marking evidence.

CRA SBOM and Vulnerability Management Template

Build a CRA-ready SBOM and vulnerability handling record with component inventory, triage, remediation, disclosure, reporting, update, and technical documentation fields.

CRA vs RED Cybersecurity Delegated Act

Compare the EU Cyber Resilience Act with the RED cybersecurity delegated act for connected and radio equipment, including scope, timing, evidence, and transition treatment.

CRA Vulnerability Handling and Disclosure | Article 14 Reporting and Security Updates

How EU Cyber Resilience Act manufacturers should run vulnerability intake, remediation, coordinated disclosure, Article 14 reporting, secure updates, and evidence records.

EU CRA Compliance Program for Manufacturers and Economic Operators

Build a Cyber Resilience Act compliance program around product scope, Annex I security requirements, conformity assessment, technical documentation, vulnerability reporting, and market surveillance.

EU CRA vs UK PSTI Product Security Regime

Compare EU Cyber Resilience Act and UK PSTI product-security scope, duties, evidence, dates, actors, and enforcement for connected products.

EU Cyber Resilience Act Checklist for Product Security and CE Marking

A CRA checklist for products with digital elements: scope, Annex I security controls, vulnerability handling, Article 14 reporting, technical documentation, conformity assessment, CE marking, and support-period evidence.

EU Cyber Resilience Act FAQ

Direct CRA FAQ answers on scope, economic-operator roles, essential requirements, vulnerability reporting, conformity assessment, CE marking, support periods, and market surveillance.

CRA Blue Guide Concepts FAQ | Placing on the Market, Making Available, Distance Sales

CRA FAQ explaining Blue Guide market-access concepts for products with digital elements: placing on the market, making available, imports, CE marking, operator roles, online sales, stock, and testing exceptions.

CRA CE Marking FAQ | Conformity Assessment, EU Declaration, Evidence

Practical CRA CE marking answers for products with digital elements: conformity assessment, EU declaration, technical documentation, standards, software placement, and launch evidence.

CRA Component Due Diligence FAQ | Third-Party Software, FOSS, SBOMs

Cyber Resilience Act FAQ on manufacturer due diligence for integrated components, third-party software, FOSS dependencies, SBOMs, vulnerability handling, and evidence records.

CRA Conformity Assessment Routes FAQ | Module A, Module B+C, Module H, Important and Critical Products

Cyber Resilience Act FAQ on when manufacturers can use module A, when module B+C or module H is required, and how important and critical products affect the route.

CRA Cybersecurity Risk Assessment FAQ | Article 13, Annex I, Updates

CRA FAQ on Article 13 cybersecurity risk assessments, Annex I applicability, intended purpose, foreseeable use, technical documentation, and update evidence.

CRA Declaration of Conformity FAQ | Annex V, Simplified Declaration, CE Marking

FAQ on the Cyber Resilience Act EU Declaration of Conformity: Annex V contents, simplified Annex VI wording, CE marking link, technical documentation, retention, updates, and operator duties.

CRA Economic Operators FAQ | Manufacturers, Importers, Distributors, Authorised Representatives

CRA FAQ on economic-operator roles: manufacturers, importers, distributors, authorised representatives, substantial modification, traceability, and evidence controls.

CRA Essential Cybersecurity Requirements FAQ | Annex I Part I and Part II

CRA FAQ on Annex I product cybersecurity requirements, vulnerability handling, secure-by-default design, risk assessment, documentation, lifecycle duties, and user information.

CRA Hardware and Software Boundaries FAQ | Product Scope, Components, RDPS

FAQ on Cyber Resilience Act hardware and software boundaries: combined products, standalone software, source code, components, remote data processing, SaaS and market-placement changes.

CRA Harmonised Standards FAQ | Presumption of Conformity, Common Specifications

Cyber Resilience Act FAQ on how harmonised standards, common specifications, certification schemes, and OJ publication affect CRA conformity evidence.

CRA Important and Critical Products FAQ | Annex III, Annex IV, Conformity Assessment

FAQ on CRA important and critical products, Annex III and Annex IV classification, core functionality, and conformity assessment consequences.

CRA Integrated Components and Dependencies FAQ | Third-Party Software and SBOM Evidence

Cyber Resilience Act FAQ on integrated components, third-party software, remote data processing, SBOM-style evidence, upstream fixes, FOSS dependencies, and manufacturer responsibility.

CRA Interplay With EU Product Laws FAQ | RED, Machinery, Data Act

Official source CRA FAQ on overlap with the Radio Equipment Directive, Machinery Regulation, GPSR, Data Act, exclusions, declarations, documentation, and existing certificates.

CRA Known Exploitable Vulnerabilities at Launch FAQ

FAQ for Cyber Resilience Act launch decisions: known exploitable vulnerabilities, CVEs, component flaws, secure-by-default settings, release gates, Article 14 reporting, and evidence.

CRA Legacy Products FAQ | Pre-11 December 2027 Products

Cyber Resilience Act FAQ on products placed on the market before 11 December 2027, Article 14 reporting, substantial modification, distributor stock, spare parts, and records.

CRA Manufacturer Obligations FAQ | Article 13, Annex I, CE Marking

FAQ for Cyber Resilience Act manufacturers covering Article 13 duties, risk assessment, Annex I, vulnerability handling, support periods, documentation, conformity assessment, reporting, CE marking, and evidence controls.

CRA Market Surveillance and Enforcement FAQ | Authorities, Corrective Action, Safeguards

Cyber Resilience Act FAQ on market-surveillance authorities, investigations, corrective action, withdrawal, recall, safeguards, sweeps, documentation access, and penalties.

CRA Module B+C FAQ | EU-Type Examination, Conformity to Type, Notified Bodies

CRA Module B+C FAQ explaining EU-type examination, conformity to type, notified-body evidence, production control, CE marking, declarations, and certificate changes.

CRA Module H FAQ | Full Quality Assurance, Notified Body Surveillance, CE Marking

CRA Module H FAQ explaining the full-quality-assurance route, notified-body assessment, quality-system scope, technical documentation, CE marking, declarations, and records.

CRA Notified Bodies FAQ | Scope, Modules B+C and H, Certificates

Practical CRA FAQ on when notified bodies are needed, how CRA bodies are designated, what their notified scope means, and how Module B+C and Module H assessments work.

CRA Open-Source Software FAQ | FOSS Scope, Stewards, Manufacturers

Cyber Resilience Act FAQ for free and open-source software: commercial activity, steward duties, manufacturer due diligence, vulnerability handling, public documentation, and user obligations.

CRA Over-the-Air Updates FAQ

Cyber Resilience Act FAQ on OTA updates, automatic security updates, secure update distribution, support-period evidence, and offline update paths.

CRA penalties and fines FAQ | Article 64 fine caps

FAQ on EU Cyber Resilience Act Article 64 penalties: maximum fine tiers, turnover caps, national enforcement, economic operators, reporting duties, and open-source steward carve-outs.

CRA Product Families FAQ | Variants, Shared Assessments, Family Reuse, Conformity Scope

CRA FAQ on product families, variant grouping, shared technical documentation, conformity evidence, and when cybersecurity-relevant differences need separate assessment.

CRA Products With Digital Elements Scope FAQ

EU Cyber Resilience Act FAQ on products with digital elements, software, firmware, remote data processing, components, exclusions, market placement, and CRA operator boundaries.

CRA Remote Data Processing Solutions FAQ | Product Scope, Cloud and Backend Boundaries

FAQ on how the EU Cyber Resilience Act treats remote data processing solutions, manufacturer-controlled backends, third-party cloud services, SaaS, risk assessment, documentation, and user information.

CRA Reporting Obligations FAQ | Article 14, CSIRTs, ENISA, User Notices

Cyber Resilience Act FAQ on Article 14 reporting for actively exploited vulnerabilities and severe incidents, including timing, CSIRT routing, ENISA access, user notices, and evidence.

CRA Secure-by-Default FAQ | Default Configuration and Annex I Controls

Cyber Resilience Act FAQ on secure-by-default configuration, automatic security updates, attack surface reduction, authentication, data minimisation, user information, and tailor-made products.

CRA Security Updates vs Functionality Updates FAQ

Cyber Resilience Act FAQ on classifying security updates, functionality updates, support-period duties, automatic updates, user notices, and substantial-modification review.

CRA Substantial Modification FAQ | Updates, Repairs, Manufacturer Duties

Cyber Resilience Act FAQ on when software updates, repairs, spare parts, and post-market changes become substantial modifications and trigger CRA manufacturer, evidence, and conformity duties.

CRA Support Period FAQ | Expected Product Lifetime, Security Updates, User Information

Practical CRA FAQ on how manufacturers determine support periods, disclose support end dates, keep security updates available, and document support-period evidence.

CRA Tailor-Made Products FAQ | Bespoke Products, Market Placement, Evidence

FAQ on when a bespoke product may be treated as tailor-made under the EU Cyber Resilience Act, what the carve-out changes, and what manufacturers still need to document.

CRA Technical Documentation FAQ | Annex VII Evidence and Technical File

CRA FAQ explaining Annex VII technical documentation, risk assessment evidence, conformity assessment files, vulnerability handling records, product families, RDPS, language, and authority access.

CRA Transition Period FAQ | Entry Into Force, Application Dates, Reporting, Legacy Products

CRA FAQ on the transition period covering entry into force, 2026 reporting, 2027 application, legacy products, stock, customs timing, and software versions.

CRA Update Availability and Software Archives FAQ

FAQ on CRA security-update availability, support-period notices, optional public software archives, historical versions, and Article 13(10) software-version limits.

CRA User Information and Transparency FAQ | Annex II Instructions

Practical CRA FAQ on Annex II user instructions, support-period disclosure, vulnerability contacts, update notices, importer and distributor information.

CRA Vulnerability Handling FAQ | Support Periods, Components, Reporting

Practical CRA FAQ on vulnerability handling: SBOMs, remediation, coordinated disclosure, component issues, security updates, support periods, Article 14 reporting, and user notices.

Cyber Resilience Act Module A FAQ | Internal Production Control

FAQ on when CRA Module A internal production control is available, when it is blocked, and what documentation, testing, standards, and evidence it still requires.

EU Cyber Resilience Act Core Functionality FAQ | CRA Product Classification

CRA FAQ on core functionality, product boundaries, remote data processing, integrated components, ancillary functions, and software changes that affect product classification.

EU Cyber Resilience Act Repairs and Spare Parts FAQ

CRA FAQ for repairs, spare parts, legacy products, security updates, substantial modification, and responsibility after product changes.