Software manufacturers covered by the EU Cyber Resilience Act (CRA) should create a product-specific technical file before placing each product with digital elements on the market. The file must show how the product and the manufacturer’s processes meet the CRA’s essential cybersecurity requirements, include the applicable information in Annex VII, contain the cybersecurity risk assessment and its justifications, and be updated where appropriate during the support period. The technical file and EU declaration of conformity must remain available to market-surveillance authorities for at least 10 years after market placement or for the support period, whichever is longer.
First confirm that the CRA obligation applies
This is a documentation guide, not a product-scope determination. The CRA applies to products with digital elements, but exclusions, product categories and special rules can affect the result. Confirm the product’s status under the Regulation, the applicable conformity-assessment route and the commencement or transitional dates before treating a requirement as currently enforceable for a particular product.
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The governing text is Regulation (EU) 2024/2847. Article 31 and Annex VII set out the technical-documentation content, while Article 13 in the consolidated text contains related manufacturer and vulnerability-handling duties. The European Commission may supplement Annex VII by delegated acts to reflect technological developments and implementation experience, so maintain a process for checking later measures.
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Article 31 requires the technical documentation to be prepared before the product is placed on the market. It must contain the relevant data and details of the means used to ensure that the product and the manufacturer’s processes comply with Annex I, plus at least the applicable elements of Annex VII. The documentation is not a generic corporate policy manual: it should let an authority understand the specific product, its versions, its security decisions and the evidence behind the conformity claim.
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The Regulation states: “The technical documentation shall be drawn up before the product with digital elements is placed on the market and shall be continuously updated, where appropriate, at least during the support period.” Keep a controlled revision history so that an auditor can identify what was true at each release and why later changes were made.
Annex VII: the core contents of the file
Annex VII is a minimum content list. Include only what is applicable, but record why an item is not relevant rather than silently omitting it.
| Annex VII area | Records to assemble | Useful traceability detail |
|---|---|---|
| Product description | Product name and identifiers; intended purpose; hardware illustrations where applicable; relevant software versions that affect compliance; and user information or instructions. | Connect each document to a release, configuration, supported hardware model and publication date. |
| Design, development and production | A description of the design, development and production processes used for the product. | Reference controlled requirements, architecture decisions, build or release controls and change approvals. |
| Vulnerability handling | A description of the vulnerability-handling process. | Show intake channels, triage, severity decisions, remediation, disclosure and update-release steps. |
| Architecture and components | Information about the product’s architecture and the relationships between components. | Maintain a versioned component inventory or software bill of materials where it helps identify dependencies and affected releases. |
| Standards and specifications | The applicable harmonised standards, common specifications and relevant cybersecurity certification schemes used for conformity. | Record the edition, clauses or profiles relied on and the product versions to which they apply. |
| Alternative solutions | If a listed standard, specification or scheme is not applied, describe the technical solutions used to satisfy the essential requirements and list other relevant technical specifications applied. | Map each alternative control to the requirement it addresses and retain supporting test or review evidence. |
Annex VII is not a prescribed folder tree or software format. A manufacturer may use a document-management system, repository or controlled physical records, provided the resulting file is complete, readable, retrievable and protected against unauthorised alteration.
Document the cybersecurity risk assessment
The risk assessment is a central part of the technical documentation, not a separate exercise that can be discarded after a design review. Use it to show which CRA security requirements apply to the product, the threats and assumptions considered, the controls selected and how those controls are implemented and verified.
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- Define the assessment boundary: identify the product, versions, interfaces, operating environment, connected services and security-relevant dependencies.
- Record applicability decisions: for every requirement treated as not applicable, state the product-specific facts that support that conclusion.
- Link risks to controls: connect each material risk to design measures, configuration requirements, tests, monitoring or user instructions.
- Capture residual risk and assumptions: identify conditions such as required updates, administrator privileges, supported platforms or customer configuration.
- Reassess after change: update the assessment when new vulnerabilities, component changes, architecture changes or other information alters the risk picture.
A concise requirements-to-evidence matrix makes the assessment auditable. Give each requirement an identifier, applicability status, implementation reference, verification evidence, owner and last-review date.
Keep component and third-party due-diligence evidence
Manufacturers must exercise due diligence when integrating third-party components. The technical file should therefore substantiate how dependencies were identified and evaluated, rather than merely listing a vendor name.
- Maintain a component inventory tied to product and release versions.
- Record component origin, version, licence or usage conditions that affect security maintenance, and known security advisories considered.
- Retain supplier security information, review results and decisions to accept, replace, isolate or upgrade a component.
- Document how a vulnerable dependency is mapped to affected products and how a fix or mitigation is delivered.
The cited CRA provisions do not prescribe a particular software bill of materials schema or an exact internal evidence template. Choose a format that allows a reviewer to reproduce the component and risk decisions for a shipped version.
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Article 13 requires manufacturers to systematically document relevant cybersecurity aspects proportionately to the product’s nature and cybersecurity risks. That includes vulnerabilities the manufacturer becomes aware of and relevant information supplied by third parties. Where new information changes the security picture, update the risk assessment where appropriate.
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At minimum, retain a record for each material vulnerability or credible report showing:
- when and how it was received or discovered, including the affected component and product versions;
- initial validation, severity and exploitability reasoning;
- containment, mitigation, patch or configuration decisions and their approvals;
- tests performed before release, affected builds and release dates;
- customer or coordinated-disclosure communications, where applicable; and
- the resulting risk-assessment change, or a reason no change was necessary.
Keep links between a vulnerability record, the issue or advisory, the code or configuration change, the verification result and the security update. This chain is more persuasive than a collection of unconnected tickets.
Show how conformity was assessed
The technical file should contain the evidence supporting the selected conformity-assessment procedure and the EU declaration of conformity (DoC). Depending on the product and route, that evidence may include design reviews, security test reports, penetration-test conclusions, configuration records, corrective-action logs, certificates or notified-body correspondence. Include the version and scope of every report so that it is clear which product was assessed.
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Retain the signed or otherwise controlled EU DoC with the product file. If another Union legal act also requires technical documentation for the same product, Article 31 permits a single set that contains both the CRA Annex VII information and the information required under that other act. Avoid duplicate versions that can diverge; use one master record with clearly separated legal mappings.
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Keep user information and security updates accessible
User information and instructions are part of the product evidence. Keep the released instructions, security configuration guidance, update instructions, supported-environment information and limitations associated with each relevant version. If supplied online, the information must remain accessible and user-friendly for the applicable minimum period.
Do not confuse retaining an internal engineering record with keeping a security update available. Security updates made available during the support period must remain available after issue for at least 10 years or for the remainder of the support period, whichever is longer. Track the publication date, affected versions, withdrawal date (if any) and the support-period end date in a separate update-availability register.
Apply the retention and access rules
| Record | Minimum availability rule | Operational control |
|---|---|---|
| Technical documentation | Available to market-surveillance authorities for at least 10 years after the product is placed on the market, or for the support period, whichever is longer. | Record the first market-placement date for each product and calculate the later of the two end dates. |
| EU declaration of conformity | Available on the same 10-year-or-support-period basis. | Preserve the exact declaration version associated with the product and conformity route. |
| User information and instructions | Available to users and authorities for the corresponding minimum period; online material must remain accessible and user-friendly. | Use durable URLs or an archival service, monitor availability and retain prior released versions. |
| Security updates | Each update made available during support must remain available for at least 10 years after issue or for the remainder of the support period, whichever is longer. | Maintain an update catalogue with issue date, affected versions, download location and end-of-availability date. |
Protect long-lived records with access controls, integrity checks, backups, format migration and a documented retrieval procedure. Authorities should be able to receive a complete, readable set without relying on an employee’s personal account or a discontinued build system.
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Control language, access and correspondence
Article 31 sets a language rule for technical documentation and conformity-assessment correspondence: use an official language of the Member State where the notified body is established, or a language that the notified body accepts. Decide the working and submission languages early, record the notified body’s acceptance where relevant and retain translated versions with their source documents.
Separate public user material from restricted evidence, but do not let confidentiality controls prevent timely production to a competent authority. Define who can approve a release, alter a risk assessment, close a vulnerability record or provide the file externally.
A practical product-file index
The following index is an organizing approach inferred from the CRA’s content and retention rules; it is not a mandatory template.
- Product identity: name, identifiers, intended purpose, market-placement date, support-period dates and a version map.
- Product description: relevant software versions, applicable hardware illustrations, operating environments and released user instructions.
- Architecture and components: system diagrams, interfaces, component relationships and versioned dependency inventory.
- Process descriptions: design, development, production and vulnerability-handling processes, with owners and controlled revisions.
- Risk and requirements: cybersecurity risk assessment, Annex I requirement matrix, applicability justifications and residual-risk decisions.
- Standards and solutions: applied harmonised standards, common specifications, certification schemes, or mapped alternative solutions and technical specifications.
- Verification and conformity: test and review evidence, corrective actions, notified-body material where applicable and the EU DoC.
- Vulnerability and update history: internal and third-party reports, triage and remediation records, risk-assessment updates and security-update availability log.
- Retention and access: calculated end dates, archive locations, permissions, backup tests, language records and an authority-response procedure.
Step-by-step process for creating and maintaining the file
- Classify the product: determine whether it is a product with digital elements in CRA scope, identify exclusions and establish the applicable dates and conformity route.
- Assign ownership: name a product-file owner and owners for security engineering, development, quality, legal and support records.
- Freeze the product baseline: capture the release identifier, intended purpose, architecture, components, supported environments and market-placement date.
- Perform the risk assessment: map applicable requirements to controls, evidence and explicit non-applicability reasons.
- Collect Annex VII evidence: add process descriptions, standards or alternative solutions, architecture information, user material and vulnerability-handling procedures.
- Complete conformity activities: obtain required reviews, tests, certificates or notified-body outputs and issue the EU DoC.
- Approve before placement: check that the file is readable, internally consistent and complete before the product enters the market.
- Operate change control: for every material product, component or process change, decide whether the risk assessment, evidence, DoC or user material needs revision.
- Operate vulnerability response: record reports, decisions, fixes and update availability, then connect them to affected releases.
- Archive and test retrieval: calculate the longer retention period, preserve integrity and periodically perform a restoration and authority-response exercise.
Common failure modes and corrections
| Failure mode | Why it is weak | Correction |
|---|---|---|
| One generic security policy for every product | It does not prove how a particular product and release meet the requirements. | Create a product-specific baseline and link corporate procedures to product evidence. |
| Listing standards without showing use | A title or logo does not explain which clauses or controls were applied. | Record editions, scope, mapped requirements and verification results. |
| Leaving non-applicable requirements blank | An authority cannot tell whether the omission was deliberate or accidental. | Add a product-specific justification and reviewer approval. |
| Keeping vulnerability tickets but not decisions | Raw tickets may omit severity reasoning, affected versions and risk-assessment impact. | Use a structured record with triage, decision, remediation and assessment links. |
| Retaining the file for exactly 10 years automatically | The support period may be longer, producing a later required end date. | Calculate and monitor the longer of 10 years after placement and the support period. |
| Removing old downloads when a new patch ships | Security updates must remain available for the required period after issue. | Keep an immutable update archive and publish a version-aware catalogue. |
| Relying on an online page with no archive | Links, content and access permissions can change before the retention period ends. | Version the content, test links and preserve an authoritative snapshot. |
| Using a language the notified body has not accepted | The documentation or correspondence may not satisfy the Article 31 language condition. | Confirm the accepted language and retain source and translated records. |
What the CRA does not prescribe
The cited provisions do not mandate a particular document-management platform, physical binder, universal template, software bill of materials format or internal ticketing product. They require substantive information, evidence, updating and availability. Select tools according to product complexity, release frequency, supplier risk, access controls and the ability to export a complete file for an authority.
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Likewise, the CRA text does not establish a universal compliance percentage, breach rate or typical manufacturer filing practice. Avoid presenting internal targets or industry anecdotes as legal requirements.
Final compliance check
- Is there a product-specific file completed before market placement?
- Does it contain all applicable Annex VII information and an explanation for each non-applicable item?
- Can every security requirement be traced to a risk decision, implementation and verification record?
- Are architecture, component and third-party due-diligence records tied to product versions?
- Can vulnerability reports be traced through risk decisions, fixes and released updates?
- Are the EU DoC, user material and security updates retained and accessible for their respective periods?
- Have the longer retention end date, language, permissions, backups and retrieval process been tested?
- Is there an owner watching for delegated acts or other later CRA measures that could affect Annex VII?
A file that answers these questions gives a market-surveillance authority a coherent account of what was shipped, why its security controls were selected, how weaknesses were handled and where the supporting evidence can be found.
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