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Yes, software can be covered by the EU Cyber Resilience Act (CRA). Start with the legal category “product with digital elements,” which includes software and its qualifying remote data-processing solutions, not only physical devices. Then establish whether the product is made available on the EU market, identify the entity that develops and brands it, map any essential cloud functions, and test open-source, sectoral and statutory exclusions. Finally, compare the product’s core functionality with the “important” product categories in Annex III, because that classification affects conformity assessment.
A product name such as “SaaS,” “free app” or “open-source library” does not decide the result. The answer depends on architecture, responsibility, branding, supply and monetisation facts. Keep a written classification record; a regulator, customer or conformity-assessment body will need to see how each conclusion was reached.
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What the CRA covers
The CRA uses a technology-neutral starting point. A “product with digital elements” is a software or hardware product and its remote data-processing solutions, including software or hardware components placed on the market separately. The European Union’s legal summary gives apps and computer programmes as examples. A download, mobile application or browser-delivered program is not outside scope merely because it has no dedicated hardware.
The definition also reaches certain cloud or server-side functions. A remote data-processing solution can form part of the product when it was designed and developed by the manufacturer, or under the manufacturer’s responsibility, and the product could not perform one of its functions without that solution. A cloud service that is merely adjacent to a product therefore requires a different analysis from an integrated service on which a product function depends.
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The CRA is a product-safety and cybersecurity regime, not an automatic label applied to every software business. A final classification must connect the statutory words to the particular product, its distribution and its responsible entities.
A six-question scope test
Use these questions in order. Record the facts and documents supporting every answer rather than relying on a marketing description.
- What is the product? Define the software, included components and functions delivered to users or other products.
- Is it made available on the EU market? Map where and how the product is supplied, including free access, downloads, subscriptions, bundled distribution and business-to-business delivery.
- Who is the manufacturer? Identify the party that develops or manufactures the product, arranges its design or development, and markets it under its own name or trademark.
- Does remote processing belong to the product? Determine whether the manufacturer is responsible for the remote solution and whether the product needs it to perform a function.
- Do open-source or repository facts change the analysis? Examine monetisation, supply, integration, responsibility and any software-steward role instead of assuming an exemption.
- Is there an exclusion or an Annex III classification? Check sector-specific rules and statutory exclusions, then test whether the product has the core functionality of an “important” product.
1. Define the product with digital elements
Include software delivered without hardware
List every software element supplied as a product: desktop programs, mobile apps, firmware, libraries, plugins, operating components and separately marketed modules. The CRA’s starting definition is expressly broad enough to include software products such as apps and computer programmes. Do not reject a classification because the software is downloaded, delivered through an app store or used through a web interface.
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Write a short functional description that a third party could understand. Identify what the software does, which devices or networks it connects to, what data it processes, and which external components are necessary for each user-facing function. Keep architecture diagrams, interface specifications, deployment instructions and release records with the classification file.
This step prevents two common errors: treating an entire platform as one undifferentiated product when separate components are supplied independently, or treating an essential component as an unrelated service simply because it runs on a server.
2. Establish EU-market availability and the responsible role
Map the supply route
Document how the product reaches users or customers in the EU. Consider direct sales, app or package distribution, subscriptions, pre-installed bundles, enterprise contracts, managed deployments and free downloads. Note the relevant country, entity, date and channel for each route. A product can raise CRA questions even when no licence fee is charged, because the manufacturer definition expressly covers supply “whether for payment, monetisation or free of charge.”
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Free access is therefore not a general escape from the manufacturer role. It is still necessary to establish whether the product is being made available on the EU market and which legal entity is responsible for it.
Identify manufacturer, importer, distributor and authorised-representative facts
The manufacturer is the person or company that develops or manufactures a product, has it designed, developed or manufactured, and markets it under its own name or trademark. The definition applies whether the product is paid, monetised or free. Record:
- the entity named in the product, documentation, installer, package metadata and terms;
- who controls the product roadmap, source changes, releases and security decisions;
- whether another company designed or built the software under contract;
- which entity places its name or trademark on the product; and
- which parties import, resell, distribute or represent the product in the EU.
A contractor that writes code is not automatically the CRA manufacturer. Conversely, a vendor can be the manufacturer even when development is outsourced, if it has the product developed and markets it under its own name or trademark. Keep contracts, trademark records and release ownership evidence.
3. Decide whether cloud processing is part of the product
For each server-side component, apply both limbs of the statutory test:
- Responsibility: Was the remote data-processing solution designed and developed by the manufacturer or under its responsibility?
- Functional dependence: Without that solution, would the product be unable to perform one of its functions?
Both questions matter. A manufacturer-controlled service that is optional analytics may not satisfy functional dependence. A service that is technically indispensable but independently designed and operated may require a different allocation of responsibility. Capture the answer per function rather than making one broad statement about “the cloud.”
Practical SaaS scenarios
| Scenario | Facts to verify | Why the label alone is insufficient |
|---|---|---|
| Web application whose core workflow runs on the vendor’s servers | Who designed the processing, who brands the application, and which functions fail when the service is unavailable | “SaaS” describes delivery, not whether remote processing is part of a product with digital elements |
| Downloadable client with an optional hosted dashboard | Whether the client performs its promised functions without the dashboard and whether the vendor controls the dashboard | An optional adjacent service may be different from an essential remote function |
| Software that requires a vendor-operated licence or authentication service | Whether authentication is necessary for a defined product function and who developed the service | A dependency can be functionally important even when users see only the local program |
| Independent hosting used by a customer to run supplied software | Whether the host was designed or developed under the software manufacturer’s responsibility and whether the software depends on that host | Customer infrastructure is not automatically the manufacturer’s remote solution |
Keep a dependency matrix showing each product function, the remote component supporting it, the developer or operator, and the effect of removing it. This is more defensible than classifying an entire cloud portfolio as either “covered” or “not covered.”
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4. Analyse free and open-source software carefully
Open-source availability does not produce a single CRA answer. The Regulation distinguishes free and open-source software that is not monetised by its manufacturer from commercial supply. It also creates a tailored role for some open-source software stewards supporting software intended for commercial activities.
Questions for an open-source project
- Who publishes the software and under which name or trademark?
- Is anyone monetising downloads, support, hosted access, dual licensing, paid features or another commercial activity?
- Is the software intended to be integrated into commercial products?
- Who decides releases, security fixes and accepted contributions?
- Does an organisation meet the statutory conditions for an open-source software steward?
- Is a company incorporating the code into a branded product taking on a manufacturer role for that product?
Do not treat a permissive licence, a zero price or a public repository as conclusive. The actual supply and responsibility arrangement controls the analysis. A non-monetised project may be treated differently from commercial supply, while a steward supporting commercial use can have a specific regulatory position. Obtain advice on the project’s facts where the role is unclear.
Repository hosting is not, by itself, market placement
The Regulation states: “The sole act of hosting products with digital elements on open repositories, including through package managers or on collaboration platforms, does not in itself constitute the making available on the market of a product with digital elements.”
This rule prevents a repository operator from becoming a distributor merely by providing hosting. It does not decide what the publisher, integrator, commercial vendor or steward is doing. Examine who supplies the software, who monetises it, how it is promoted and how it is integrated.
5. Check sectoral rules and statutory exclusions
Other Union cybersecurity legislation
The Regulation provides a conditional mechanism to limit or exclude products covered by other Union rules addressing the same cybersecurity risks when doing so is consistent with the overall framework and the other regime provides equivalent or higher protection. Do not assume that belonging to a regulated sector automatically removes the CRA. Identify the exact product, the other legal instrument, the overlapping risk and the equivalence of protection.
Specified exclusions
Test the wording of each exclusion against the product’s design and certification records. The listed categories include:
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- certain aviation-certified products;
- marine equipment covered by the relevant rules;
- identical-specification spare parts;
- products developed or modified exclusively for national security or defence; and
- products specifically designed to process classified information.
These are text-specific tests. A company operating in aviation, defence or maritime markets is not enough; the particular product must meet the applicable statutory condition. Preserve certification, procurement, design-purpose and information-classification evidence.
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After establishing that the product is within the general scope, compare its core functionality with the categories listed in Annex III. A match makes it an “important” product with digital elements and triggers the conformity-assessment procedures referenced in Article 32. The classification is based on what the product fundamentally does, not on a marketing slogan or the presence of one security feature.
Risk indicators to examine
The Regulation identifies risk-related considerations such as products that primarily secure other products, networks or services, and products whose functions can create significant effects through control, disruption or damage. Use these indicators to focus the Annex III comparison, but do not substitute them for the category text.
Document the Annex III decision
- Copy the product’s core functions from technical documentation and user materials.
- Review every potentially relevant Annex III category.
- Explain in plain language why the core function does or does not match each category.
- Record whether the product is supplied alone, embedded in another product or offered as a component.
- Route a positive or genuinely uncertain match to the conformity-assessment team before release planning.
Two products from the same vendor can have different classifications if their core functions differ. Conversely, changing the user interface or product name does not avoid an Annex III category when the underlying function remains the same.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.A comparison framework for borderline products
| Comparison | Facts that favour CRA product analysis | Facts that may point to a different analysis |
|---|---|---|
| Product versus standalone service | A defined software product is supplied, with functions users receive as that product | Only an independent service is supplied and no product or essential product component is identified |
| Manufacturer-controlled remote processing versus independent service | The manufacturer designed the processing and the product cannot perform a function without it | The service is optional or independently designed and is not required for a product function |
| Manufacturer versus importer or distributor | The entity develops or commissions development and uses its own name or trademark | The entity only imports or resells another party’s branded product |
| Commercial open source versus non-monetised publication | There is monetisation, commercial integration or a steward arrangement supporting commercial activity | Free, non-monetised publication with no facts indicating a commercial manufacturer role |
| General CRA route versus sectoral treatment | No valid equivalent or higher-protection sectoral rule applies | A specific Union regime addresses the same cybersecurity risks and satisfies the Regulation’s conditions |
| Ordinary versus important product | Core functionality matches an Annex III category | No Annex III category matches the product’s core functionality |
Build a defensible classification record
Create one file for each product or clearly defined product family. Include the following sections.
Product identity
- Product name, version, release date and separately supplied components.
- Functional description, architecture diagram and interfaces.
- Deployment model: local, embedded, hosted, hybrid or downloadable.
- Required remote services and the function each one enables.
Market and role evidence
- EU countries and channels in which the product is supplied or offered.
- Prices, subscriptions, advertising, support fees or other monetisation, including a record when access is free.
- Brand, trademark and packaging evidence.
- Development, outsourcing, licensing, reseller, importer and representative contracts.
Open-source and dependency evidence
- Repository locations, licences and contribution policies.
- Maintainer or steward identity and decision rights.
- Commercial integration, support and hosted-service arrangements.
- Third-party components and the party responsible for each release.
Exclusion and importance analysis
- Sector certifications and the exact legal basis for any proposed exclusion.
- Comparison with every relevant Annex III category.
- Reasoned conclusion on whether Article 32 conformity-assessment procedures apply.
- Reviewer, approval date and trigger for reassessment after a major architecture or business-model change.
Common mistakes and how to correct them
“It is SaaS, so the CRA cannot apply”
Correct the assumption by mapping the product’s essential remote functions. The CRA definition can include remote processing when the manufacturer is responsible for it and the product needs it to perform a function.
“It is free, so there is no manufacturer”
Correct the assumption by checking the manufacturer definition and the actual market supply. The definition expressly covers products supplied free of charge. Open-source treatment requires a separate analysis of monetisation and stewardship.
“The repository host is the distributor”
Correct the assumption by applying the repository rule. Hosting alone does not constitute making a product available on the market, although the publisher or commercial integrator may have a different role.
“Our industry is regulated, so the CRA is excluded”
Correct the assumption by identifying the exact product and overlapping cybersecurity rule. The sectoral mechanism is conditional, and the listed exclusions are specific.
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“A security feature makes the product important”
Correct the assumption by comparing core functionality with Annex III. A product’s marketing category or one protective feature is not the test.
“One classification covers every version”
Correct the assumption by setting reassessment triggers. A change in branding, cloud dependency, monetisation, target market, core function or sector certification can change the result.
Timing, guidance and change control
The CRA provides for staged application rather than one universal compliance date. Before setting release, sales or support deadlines, verify the current text, applicable dates, delegated acts and Commission guidance. Different obligations can begin at different stages, and transition effects can depend on the product and its supply history.
In particular, monitor guidance on remote processing, free and open-source software, scope and substantial modification. Where guidance is absent or a product-specific interpretation remains uncertain, state the facts, the legal test applied and the residual uncertainty in the classification record. Revisit the record when the architecture, cloud provider, ownership, branding, monetisation, market geography or intended use changes.
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Internal teams can usually complete the factual inventory. Specialist CRA scope or conformity-assessment advice is prudent when the product combines local software with indispensable cloud functions, is supplied under several brands, incorporates open-source code into commercial products, may qualify for a sectoral exclusion, or appears to match an Annex III category. Give the adviser the architecture, contracts, supply routes and classification record; a product-specific opinion is more useful than a generic statement that “software is covered.”
Final decision rule
Classify the product as potentially within the CRA when it is a software or hardware product with digital elements, is made available on the EU market, and the responsible branded entity meets the manufacturer test. Include a remote data-processing solution when the manufacturer is responsible for its design and the product needs it for a function. Then resolve open-source, repository, sectoral and statutory-exclusion questions and perform the Annex III core-functionality test. If any material fact is unknown, record the classification as provisional and close the evidence gap before relying on an exclusion or planning conformity assessment.
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