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Short answer: software can be covered by the EU Cyber Resilience Act (CRA), even when it is delivered as an app, download, cloud-connected product or free service. Start by classifying it as a possible “product with digital elements,” then check whether it is made available on the EU market, who markets it under a name or trademark, whether manufacturer-controlled remote processing is functionally necessary, and whether open-source, sectoral or statutory exclusions apply. Finally, compare the product’s core functionality with the “important product” categories in Annex III.
The answer is product-specific. The word “SaaS,” “open source” or “software” does not by itself decide coverage.
1. Start with the CRA’s product definition
Regulation (EU) 2024/2847 defines a “product with digital elements” broadly. It includes software and hardware products and their remote data-processing solutions, including components placed on the market separately. The EUR-Lex summary gives software products such as apps, video games and computer programmes as examples. A dedicated physical device is not required.
A practical first screen is therefore:
- Is there identifiable software or hardware?
- Can it connect directly or indirectly to a device or network?
- Is a remote data-processing function supplied as part of the product?
- Is the item made available on the EU market?
If the answer to the first question is yes, do not dismiss the CRA merely because the product is downloaded, delivered through an app store, accessed through a browser or supplied without hardware.
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Software supplied separately
A separately marketed application, desktop program, library, operating component or other software package can be a product with digital elements. The assessment concerns what is supplied and how it is marketed, not whether the code is physically embedded in a device.
Connected products and components
The definition also reaches products that connect indirectly to devices or networks. A component sold separately can therefore need its own assessment even when it is later integrated into a larger product. Record the component’s functions, supply route and branding rather than assuming the integrator’s classification automatically controls.
2. Identify the market and the legally relevant business role
Next establish whether the product is made available on the EU market and identify the entity responsible for placing it there. The CRA’s manufacturer definition covers a person or company that:
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- has it designed, developed or manufactured; and
- markets it under its own name or trademark.
The definition applies “whether for payment, monetisation or free of charge.” Free access is therefore not a general escape from the manufacturer role. A company that commissions development and releases the result under its own brand may be the manufacturer even if another company wrote the code.
“whether for payment, monetisation or free of charge”
Separate the economic role from the supply route
Make a role map for every distribution path. It should identify the manufacturer and, where relevant, an importer, distributor or authorised representative. The same software may travel through an app store, a reseller, a package registry and a direct download; each route should be documented, but the route does not by itself determine who the manufacturer is.
Branding is a key fact
Capture the name, trademark, product page, licence notice and customer-facing terms used at the point of supply. If your organisation markets the software under its own name, that fact can be decisive even where development is outsourced or the underlying code originated elsewhere.
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Cloud and server-side functions require a two-part test. A remote data-processing solution is included where:
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- the manufacturer designed and developed it, or it was designed and developed under the manufacturer’s responsibility; and
- without that remote processing, the product could not perform one of its functions.
Document both elements. “Our application uses a cloud service” is not enough to decide the issue.
Map the architecture
Draw the product boundary and list every server-side element involved in normal operation: authentication, synchronisation, policy enforcement, model inference, storage, update delivery, telemetry and administration. For each element, record who designed it, who controls changes and whether the client software can perform the relevant function without it.
Distinguish a necessary function from an adjacent service
A cloud dashboard that is merely convenient or an optional analytics service may be adjacent to the product. By contrast, a client that cannot authenticate, execute its principal function or receive required data without the manufacturer-controlled service presents a stronger case that the remote processing forms part of the product. The statutory test depends on functional dependence and responsibility, not on the label “cloud” or “SaaS.”
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- Describe the item. Write a plain-language description of the software, hardware, separately supplied components and remote processing. Include versions and major modules.
- List the functions. Identify the product’s core and supporting functions, the devices or networks it connects to and any function that fails when a server-side service is unavailable.
- Record EU availability. Note how and where the product is offered to EU customers, including direct sales, downloads, subscriptions, app stores, resellers and free distribution.
- Identify the responsible entity. Determine who develops the product, commissions its development and markets it under a name or trademark. Preserve contracts that allocate design and development responsibility.
- Classify the supply roles. Separately record manufacturer, importer, distributor and authorised-representative activities for each route to market.
- Apply the remote-processing test. For each cloud or server-side function, document manufacturer responsibility and whether the product can perform the function without it.
- Check open-source facts. Establish whether the software is free and open source, whether anyone monetises its supply, who integrates or supports it and whether a steward is involved.
- Screen exclusions and sector rules. Compare the product with the CRA’s statutory exclusions and with Union sectoral rules that address the same cybersecurity risks.
- Compare core functionality with Annex III. If the product’s core functionality matches an “important product with digital elements” category, apply the conformity-assessment route referenced in Article 32.
- Write the conclusion with assumptions. State the facts relied on, unresolved facts, the role assigned to each entity and the reason the ordinary, excluded or important-product route was selected.
5. How common software delivery models fit the analysis
Browser-based SaaS
Calling a product SaaS does not settle coverage. Examine the browser client, APIs, service-side processing and account functions together. If the provider designed the remote processing and the customer-facing product cannot perform one of its functions without it, the cloud element may be included in the product. If the service is an independent offering that only complements a separate product, the boundary may be different.
Mobile and desktop applications
An app or computer programme is within the starting software concept. Check the developer or commissioning company, the name under which it is offered, its EU availability and any mandatory backend. A free download still requires the same role and market analysis.
Software embedded in hardware
Assess the device, embedded software and separately supplied components. A connected appliance may depend on a manufacturer-controlled update, authentication or control service. Map which entity markets each element and whether the software is supplied separately or only with the device.
Developer tools and libraries
A library or tool can be assessed as a separately supplied software component. The relevant facts include the licence, release channel, branding, monetisation, intended integration and who assumes responsibility for development and maintenance. Do not decide solely from whether downstream users are developers.
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6. Free and open-source software: why there is no automatic answer
The CRA distinguishes non-monetised free and open-source supply from commercial supply, and it creates a tailored role for certain open-source software stewards supporting software intended for commercial activities. These rules require a factual review rather than a blanket “covered” or “exempt” label.
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Questions to answer
- Is the code genuinely available under an open-source licence?
- Is the manufacturer’s supply non-monetised, or is there direct or indirect monetisation?
- Who packages, signs, distributes, supports or integrates the software?
- Is a foundation, company or other steward performing the statutory steward activities?
- Is the software intended for commercial integration or merely published for general use?
Keep evidence for sponsorship, paid support, hosted editions, dual licensing, commercial packaging and responsibility for releases. A project can have a free community edition and a separately monetised offering; assess the actual supply at issue.
Repository hosting is not, by itself, market supply
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 protects against an overly broad conclusion based only on a repository listing. It does not answer who else supplies, monetises, integrates or markets the software. Examine the complete arrangement.
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7. Check exclusions and overlapping sector rules
Do not treat an industry label as an exclusion. The CRA contains specified exclusions and a conditional mechanism concerning products covered by other Union rules addressing the same cybersecurity risks. That mechanism depends on consistency with the overall framework and protection that is equivalent or higher.
Examples of stated exclusions
The Regulation identifies text-specific exclusions including:
- certain aviation-certified products;
- marine equipment covered by the relevant rules;
- identical-specification spare parts; and
- products developed or modified exclusively for national security or defence, or specifically designed to process classified information.
Confirm the exact statutory conditions before relying on any of these. A product used by a defence customer is not automatically excluded; the development purpose and design must meet the relevant wording.
Sectoral cybersecurity regimes
Where another Union framework addresses the same cybersecurity risks, compare its scope, obligations and level of protection with the CRA mechanism. Record the legal basis for any limitation or exclusion and the product characteristics that make it apply. Do not assume that being regulated in a sector removes every CRA obligation.
8. Determine whether the product is an “important product”
After deciding that the product is potentially within the CRA, compare its core functionality with the categories in Annex III. A match makes it an important product with digital elements and affects the conformity-assessment procedures referenced in Article 32.
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Focus on what the product fundamentally does
Marketing language is not a substitute for functional analysis. Describe the principal security, control, network or service function and compare it with the Annex III category. Consider whether the product primarily secures other products, networks or services, or whether its functions could create significant effects through control, disruption or damage.
Keep the classification proportional to evidence
Record the specific Annex III category considered, the core function that matches it and the facts that distinguish it from neighbouring categories. If no category matches, document that conclusion rather than calling the product “low risk” without analysis. The important-product question changes the assessment route; it is not simply a marketing tier.
9. Compare alternative classifications using the same axes
| Comparison axis | Facts to compare | Why it matters |
|---|---|---|
| Product versus standalone service | Software or hardware supplied, connected functions and contractual product boundary | Determines whether there is a product with digital elements to assess |
| Manufacturer-controlled processing versus independent service | Who designed the remote processing and whether a product function depends on it | Controls whether the remote solution is included |
| Manufacturer versus importer or distributor | Development, commissioning, branding and route to market | Assigns the relevant economic roles |
| Commercial versus non-monetised open source | Monetisation, packaging, support, integration and steward activity | Open-source treatment is fact-dependent |
| Ordinary route versus sectoral exclusion | Applicable Union rules, equivalent protection and exact statutory conditions | May limit or exclude overlapping requirements |
| Ordinary product versus Annex III category | Core functionality and risk-related effects | Determines whether important-product conformity procedures apply |
10. Worked fact patterns
A paid collaboration platform with mandatory cloud processing
The provider markets the application under its own trademark, controls the backend and charges a subscription. The client cannot perform account synchronisation or collaboration without that backend. The product is strongly indicated for a full CRA scope assessment: software is supplied on the EU market, the provider fits the manufacturer description and the remote processing appears functionally necessary. Annex III still requires a separate core-function analysis.
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The app is supplied under the developer’s name. Basic functions work offline, while analytics are an optional cloud feature. Assess the app as software, then test whether the optional analytics are part of the product. Because the core app can operate without them, the functional-dependence element may not be met for that service; document the architecture and terms rather than assuming either result.
An open-source package on a public repository
Repository hosting alone is not market availability under the quoted recital. Examine monetisation, commercial packaging, paid support, integration by another company and any steward role. A later vendor that packages and markets the library under its own name may require a separate manufacturer analysis.
A device whose essential control plane is supplied by the maker
The hardware and embedded software are sold together, while the maker’s servers provide indispensable control functions. Map the device, embedded component and remote processing, then identify who markets each element. The remote service may be included if the maker designed it and the device cannot perform a function without it.
11. Evidence file to keep for the assessment
- Product descriptions, architecture diagrams and dependency maps.
- Version history showing who approved design and development decisions.
- Brand, trademark, packaging, app-store and website records used at EU launch.
- Distribution agreements identifying importers, distributors and representatives.
- Cloud-service specifications showing responsibility, control and functional dependencies.
- Licence, repository, sponsorship, support and monetisation records for open-source components.
- Sector certifications and legal analyses supporting any exclusion or overlapping regime.
- Annex III comparison mapping the product’s core functionality to considered categories.
- A written conclusion listing assumptions, unknowns and the date on which the assessment was made.
12. Common mistakes and how to correct them
“It is free, so the CRA cannot apply”
Correct the analysis by separating price from the manufacturer definition. Free-of-charge supply is expressly included in that definition. Recheck branding, development responsibility and EU availability.
“It is only SaaS, so there is no product”
Correct the analysis by mapping the software client and remote processing. Functional dependence and manufacturer responsibility determine whether the cloud element is included.
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“Open source is always exempt”
Correct the analysis by documenting monetisation, commercial integration, packaging and steward activity. The Regulation does not create a one-size-fits-all result.
“A repository upload is market placement”
Correct the analysis by applying the recital’s specific rule: hosting alone does not constitute making the product available on the market. Then examine any separate commercial supply.
“Our sector is regulated, so we can ignore the CRA”
Correct the analysis by identifying the exact Union rule, the cybersecurity risks it addresses and whether the statutory conditions for equivalent or higher protection are met.
“The product name tells us whether it is important”
Correct the analysis by comparing core functionality with Annex III and recording the category-level reasoning.
13. Timing and keeping the conclusion current
The CRA applies in stages. Before relying on an implementation date, transition statement or conformity timetable, verify the current text, later guidance and any delegated acts. Scope can also change when architecture, branding, monetisation, distribution or sector certification changes.
Set a review trigger for major releases, a new cloud dependency, a new EU sales channel, a rebrand, a change from free to paid supply, a new commercial steward arrangement or a new Annex III-relevant function. A dated assessment with explicit assumptions is more reliable than a permanent yes-or-no label.
14. When to obtain product-specific advice
Specialist CRA scope or conformity-assessment advice is most useful where the product combines a branded application with mandatory cloud processing, uses a complex open-source supply chain, may fit an Annex III category or claims a sectoral exclusion. Provide the adviser with the evidence file above and ask for a written conclusion that separates established facts from assumptions.
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