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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, with evidence, how the product and the manufacturer’s processes satisfy the CRA’s essential cybersecurity requirements and the applicable items in Annex VII. It should include the cybersecurity risk assessment, design and component information, lifecycle and vulnerability-handling processes, conformity evidence, and the EU declaration of conformity. Keep the technical documentation and declaration available to market-surveillance authorities for at least 10 years after market placement or for the product’s support period, whichever is longer.
The checklist below follows Articles 13 and 31 and Annex VII of Regulation (EU) 2024/2847. Confirm that the product is actually in scope, check exclusions and product-specific rules, and verify the commencement or transitional dates that apply to your category before treating an obligation as currently enforceable.
What the CRA technical file is for
The technical file is the manufacturer’s product-level evidence package. It is not merely a copy of corporate security policies. Article 31 requires “all relevant data or details of the means used to ensure that the product with digital elements and the processes put in place by the manufacturer comply with the essential cybersecurity requirements” in Annex I, together with at least the applicable information listed in Annex VII.
Prepare the file before the product is placed on the EU market. Article 31(2) 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.” The wording makes the file a living record: update it when the product, its risks, its components, or the evidence supporting conformity changes.
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The Act does not prescribe a particular document-management platform, folder tree, template, or file format. A manufacturer can use an electronic quality system, controlled repository, or another method, provided the resulting records are complete, traceable, protected from unauthorised alteration, and retrievable for the required period.
What to put in the file
Product identity, purpose and versions
Start with an unambiguous description of the product and the versions covered by the assessment. Record its intended purpose, relevant hardware and software configurations, release or version identifiers that affect compliance, and the user information and instructions supplied with it. If several editions share a common security design, explain which evidence applies to each edition and where their differences change the risk or requirements.
Architecture and component relationships
Document the system architecture and how its components relate to one another. Include applicable hardware illustrations, interfaces, trust boundaries, security-relevant data flows, and a component inventory or equivalent relationship record. The objective is to let an assessor or authority understand what is being placed on the market and where each cybersecurity control is implemented.
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Annex VII calls for descriptions of the design, development and production processes relevant to conformity. Explain how security requirements become design decisions, how code and configuration changes are controlled, how builds or releases are identified, and how production or distribution preserves the assessed security properties. Link each process description to the records that demonstrate it was followed for the version under review.
Vulnerability-handling process
Describe the process used to discover, receive, assess, remediate and disclose vulnerabilities. Identify responsibilities, intake channels, triage and severity decisions, remediation or mitigation steps, verification, and communication with users. Keep the underlying records—such as reports, decisions, fixes and release references—so the process description can be substantiated rather than asserted.
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Standards, specifications and alternative solutions
List the harmonised standards, common specifications and relevant cybersecurity certification schemes applied to the product. Where a listed instrument is not applied, describe the technical solutions used to meet the corresponding essential requirements and identify other relevant technical specifications used. The file should map each solution to the requirement it addresses; a generic statement that the product “follows best practice” is not a substitute.
Conformity-assessment evidence and declaration
Retain the records supporting the chosen conformity-assessment route, test or evaluation results, corrective actions, and the final EU declaration of conformity. The declaration identifies the product and the applicable legislation; the technical file provides the detailed evidence behind that declaration. Keep both under version control so it is clear which declaration belongs to which product release.
Annex VII checklist
The following practical index translates Annex VII into a working file structure. Applicability depends on the product; include the items that apply and document the reasoning for exclusions.
| File area | Records to maintain | Useful traceability link |
|---|---|---|
| Product description | Intended purpose, product and software versions affecting compliance, applicable hardware illustrations, user information and instructions | Release, configuration and instruction revision |
| Architecture and components | Architecture description, component relationships, interfaces and security-relevant dependencies | Component or configuration identifier |
| Lifecycle processes | Design, development, production and vulnerability-handling process descriptions | Approved process version and implementation record |
| Risk and requirements | Cybersecurity risk assessment, requirement applicability and implementation rationale | Requirement-to-control or evidence reference |
| Standards and specifications | Applicable harmonised standards, common specifications, certification schemes and alternative technical specifications | Test, analysis or design evidence |
| Conformity | Conformity-assessment evidence and EU declaration of conformity | Product version and declaration date |
| Vulnerability and component intelligence | Relevant vulnerabilities discovered or received from third parties, decisions, mitigations and risk-assessment updates where applicable | Issue, ticket, advisory or release reference |
This is an organizing approach inferred from the statutory content, not a mandatory CRA filing template. The regulation allows a single set of technical documentation when another Union act also requires documentation for the same product: include the CRA Annex VII information together with the information required by that other act.
How to document the cybersecurity risk assessment
The risk assessment belongs inside the technical documentation, not in a separate file that cannot be connected to the product. It should show which CRA security requirements apply, the threats or risks considered, the controls or design choices used to address them, and the evidence that those choices were implemented.
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If a requirement does not apply, state that conclusion explicitly and give a product-specific justification. “Not applicable” without a reason leaves an assessor unable to tell whether the requirement was considered. Revisit the assessment when the architecture, intended purpose, exposed interfaces, dependency set, threat picture or vulnerability information changes.
Use stable identifiers for requirements, risks, controls, tests and releases. That linkage lets a reviewer move from a requirement to the design decision, implementation evidence, verification result and released version without relying on individual memory.
Vulnerability and third-party component records
Article 13 requires manufacturers to systematically document relevant cybersecurity aspects proportionately to the product’s nature and cybersecurity risks. That includes vulnerabilities they become aware of and relevant information supplied by third parties. Where the new information changes the risk picture, update the risk assessment and preserve the decision record.
Keep evidence of due diligence when integrating third-party components. Record the component identity and version, the information reviewed, security conditions or restrictions, known vulnerabilities, supplier communications, and the decision to accept, replace, constrain or remediate the component. The Act does not prescribe a single internal evidence format, so choose a format that is durable, attributable and easy to connect to the product release.
Do not confuse a component record with a promise that every internal engineering artifact must be retained for exactly the same period as the technical file. The legal retention rules distinguish documentation and declarations from the continuing availability of security updates.
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Retention and availability periods
Article 31 and the related Article 13 obligations establish different availability duties. Track the market-placement date and the end of the support period for every product so the longer applicable period can be calculated.
| Record or item | Minimum availability rule | Who must be able to access it |
|---|---|---|
| Technical documentation | At least 10 years after the product is placed on the market, or for the support period, whichever is longer | Market-surveillance authorities |
| EU declaration of conformity | At least 10 years after market placement, or for the support period, whichever is longer | Market-surveillance authorities |
| User information and instructions | Available for the corresponding minimum period; online material must remain accessible and user-friendly | Users and authorities |
| Security updates issued during support | Remain available after issue for at least 10 years or for the remainder of the support period, whichever is longer | Users and other entitled recipients |
The security-update rule concerns continued availability of updates, not a blanket instruction to retain every internal engineering record for that identical duration. Nevertheless, preserve enough release, vulnerability and decision evidence to demonstrate how update obligations were met.
Language, access and document control
Technical documentation and conformity-assessment correspondence must be drawn up in an official language of the Member State where the notified body is established, or in a language that the notified body accepts. Decide the language early, especially when engineering teams and assessment bodies are in different countries.
Use access controls that permit prompt production for authorities while protecting confidential source code, vulnerability details and personal data. Maintain immutable or auditable revision history, backups, retention holds for open investigations, and a documented retrieval procedure. Online user instructions and update notices should be kept usable rather than left behind a broken link or an account that no longer exists.
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A practical CRA documentation workflow
- Confirm scope and timing. Classify the product under the CRA, check exclusions and product-specific rules, and record the market-placement and support-period dates.
- Assign a product identity. Create a controlled record for the product, intended purpose, hardware and software versions, configurations and user documentation.
- Map the architecture. Capture components, relationships, interfaces and dependencies, then identify which elements affect each essential cybersecurity requirement.
- Perform and approve the risk assessment. Record applicable requirements, implementation decisions, evidence references and explicit justifications for requirements treated as not applicable.
- Collect lifecycle evidence. Attach design, development, production and vulnerability-handling process descriptions and the records showing those processes operated for the assessed release.
- Review standards and alternatives. List applied standards, common specifications and certification schemes; document alternative technical solutions where an instrument was not applied.
- Assess third-party components. Preserve due-diligence information, vulnerability intelligence and decisions for integrated components.
- Complete conformity assessment. Store test and evaluation results, corrective actions, approvals and the signed EU declaration of conformity.
- Set retention controls. Calculate the longer of 10 years after placement or the support period, schedule update availability, and test retrieval by an authorised user.
- Operate change control. Reopen the relevant evidence when releases, components, vulnerabilities, intended use or requirements change, and update the file at least as appropriate throughout support.
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Corporate policies do not prove that a particular release implements the required controls. Link process records, design artifacts, tests and decisions to the product and version assessed.
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One file for every product and edition
Shared evidence can be reused, but differences in purpose, interfaces, components or versions must be identified. Maintain a product-specific applicability statement and version mapping.
Unexplained exclusions
A requirement marked “not applicable” without a rationale looks like an omission. Record the technical facts that make it irrelevant and have the conclusion approved in the risk assessment.
Vulnerability tickets separated from the technical file
Keep a durable cross-reference from vulnerability intake and remediation records to the affected version, risk-assessment update and security release. Otherwise the manufacturer may be unable to show how newly learned information changed its decisions.
Retention measured from the wrong date
Start the calculation from the product’s market-placement date and compare it with the support-period end date. Retain for whichever period is longer, and separately track how long issued security updates must remain available.
Broken online instructions or updates
Test public links, authentication, readability and download integrity during the retention period. Keep archived versions and a controlled migration path when a service or domain changes.
Scope and changing requirements
This checklist does not determine whether every software product is within the CRA. Confirm the product category, exclusions, related Union legislation and any special conformity route before applying it to a particular offering. The Commission may supplement Annex VII through delegated acts to reflect technological developments and implementation experience, so check the current legal text and later measures before freezing a supposedly exhaustive list.
The official starting points are Regulation (EU) 2024/2847, including Article 31 and Annex VII and the consolidated text containing Article 13. A defensible file is one that lets an authority identify the product, follow the risk and design reasoning, verify the evidence, and retrieve the declaration, instructions and update history for the entire legally required period.
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