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If Your Software or Connected Product Enters the EU Market, the Cyber Resilience Act May Apply

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Start with the product, not your sector. If your business supplies software or connected hardware on the EU market—even free of charge as part of a commercial activity—the CRA may apply 1. The questions below will help you decide whether a closer assessment is needed.

If your company builds software, ships hardware with firmware, or sells connected products, the CRA belongs in your product-planning conversation before the next release or EU market-entry decision.

How the main EU cyber rules compare

Three EU cyber regimes, three different legal triggers
RegimeWhat it regulatesWhat triggers it
NIS2 — Directive (EU) 2022/2555Cybersecurity governance and operational risk management for organisations covered by Luxembourg's NIS2 ActOperating in a sector listed by Luxembourg’s NIS2 Act and meeting its size rule—or falling within a category covered regardless of size. In-scope organisations must register with their competent authority. For most sectors, that authority is the ILR; the CSSF is competent for specified entities and activities under its supervision
DORA — Regulation (EU) 2022/2554ICT risk management, incident reporting, resilience testing and ICT third-party risk for financial entitiesBeing one of the financial entities listed in DORA Article 2. In Luxembourg, the CSSF or CAA supervises the entities within its respective remit
CRA — Regulation (EU) 2024/2847Products with digital elements placed on the EU marketSupplying a product with digital elements on the EU market as part of a commercial activity, where its intended purpose or reasonably foreseeable use includes a direct or indirect connection to a device or network. The specific duties depend on whether you are the manufacturer, authorised representative, importer or distributor

Sources: CRA [1], Luxembourg NIS2 [4], Luxembourg DORA [5] and NIS2–DORA interaction [6].

What "Product with Digital Elements" Means

Article 3 defines a product with digital elements as a software or hardware product and its remote data processing solutions, while Article 2 sets the scope and connectivity criterion: the product must have a direct or indirect logical or physical data connection to a device or network 1.

A useful first check has four parts: Is it software, hardware or a component supplied separately? Is it supplied on the EU market as part of a commercial activity? Does its intended or reasonably foreseeable use include a direct or indirect connection to a device or network? And does one of the CRA's exclusions apply? 1

Check the exclusions. Some otherwise connected products are excluded because other sector rules already apply. These include specified medical and in-vitro diagnostic devices, certain motor-vehicle products, certified aviation products and marine equipment. The CRA also excludes certain identical replacement spare parts and products developed exclusively for national-security or defence purposes 1.

Cloud-connected does not automatically mean CRA-covered. A manufacturer-controlled backend forms part of the product where it was designed or developed by, or under the responsibility of, the manufacturer and the product could not perform one of its functions without it. A general website or unrelated SaaS, PaaS or IaaS service is not automatically part of the product 1 2.

The CRA also distinguishes economic-operator roles. Manufacturers have the primary design, risk-assessment, conformity, documentation, vulnerability-handling, reporting, and CE-marking obligations under Article 13 and related provisions 1. Importers and distributors have their own obligations under Articles 19 and 20, including checks before placing or making products available on the market, and Articles 21 and 22 explain when manufacturer obligations can apply to importers, distributors, or other actors 1.

Open source is not automatically exempt. Free and open-source software supplied outside a commercial activity falls outside the CRA's ordinary product rules. Monetised open-source products or components may be covered, while qualifying open-source software stewards follow a lighter, tailored set of duties 1 2.

How the CRA Differs From NIS2 and DORA

NIS2 is about the cybersecurity governance of organisations in listed sectors, including scope, management-body duties, risk-management measures, and incident reporting 4. DORA is about digital operational resilience for financial entities, including ICT risk management and third-party ICT risk 5. The CRA is about products with digital elements placed on the EU market 1.

These regimes can still meet in the same business. A Luxembourg company may face CRA duties for a product it supplies on the EU market while also falling under Luxembourg's NIS2 Act 4 or DORA 5 for its own operations. For financial entities, DORA generally takes priority over overlapping NIS2 cybersecurity risk-management and incident-reporting duties 6. See our Luxembourg NIS2 guide and DORA supplier-risk guide for the detailed scoping rules.

What the CRA Requires

The easiest way to understand the CRA is to follow the product lifecycle.

Before placing the product on the market

Based on the product's cybersecurity risk assessment, and where relevant to that product, Annex I requires measures covering areas such as secure-by-design, protection against unauthorised access, confidentiality and integrity protections, attack-surface reduction and secure updates. This is where classification, the risk assessment, secure design, technical documentation and conformity assessment sit 1.

Most products can use internal-control self-assessment. Important Class I products can self-assess only where the required standards, common specifications or eligible certification route is used; otherwise third-party assessment is needed. Important Class II and critical products follow the applicable third-party or certification route. Annex III lists important products in Classes I and II; Annex IV lists critical product categories 1 2.

When placing it on the market

At this point the manufacturer draws up the EU declaration of conformity (Article 28), affixes the CE marking (Article 30), and provides user information and instructions—including the product's support-period end-date 1.

Manufacturers must also set and document a support period that reflects how long the product is expected to be used. It will normally be at least five years, unless the expected use period is shorter. Security updates issued during that period must remain available for at least ten years after issue or for the rest of the support period, whichever is longer 1.

After placement

Annex I Part II sets vulnerability-handling requirements, including processes to identify, document, remediate and disclose vulnerabilities, provide security updates and take corrective measures. The supporting process should include a coordinated vulnerability-disclosure policy and a software bill of materials (SBOM) in a commonly used, machine-readable format covering at least the product's top-level dependencies 1.

From 11 September 2026, manufacturers report actively exploited vulnerabilities and severe security incidents through the CRA Single Reporting Platform. The process starts with an early warning within 24 hours, followed by a fuller notification within 72 hours. Final-report deadlines then differ for vulnerabilities and incidents 3.

The dates matter. The CRA entered into force in December 2024; the framework for notifying and assessing conformity-assessment bodies applies from 11 June 2026; Article 14 reporting obligations apply from 11 September 2026; and the main CRA obligations apply from 11 December 2027. Products placed on the market before 11 December 2027 are generally subject to the main CRA requirements only if they undergo a substantial modification from that date; the reporting rules are different, because Article 14 also covers in-scope products already made available before the main application date (Article 69) 1 2.

Luxembourg implementation note. As of 15 July 2026, we have not identified a published Luxembourg designation of the CRA market-surveillance or notifying authorities. ILNAS's 2025 annual report indicates that the CRA market-surveillance functions expected to fall to ILNAS were still being developed. Check Legilux, ILNAS and Ministry of the Economy updates before relying on a national route 7.

Does being an SME change the rules?

There is no general SME exemption from the CRA. The CRA nevertheless includes targeted support and reduced conformity-assessment fees. Member States may establish regulatory sandboxes, and micro and small enterprises will be able to use a simplified technical-documentation form once the Commission adopts it. Micro and small manufacturers are also protected from administrative fines solely for missing the initial 24-hour reporting deadline—but the reporting duty itself still applies 1 2.

Your First Step: Role and Product Inventory

Before attempting to plan CRA work, a manufacturer, importer, or distributor needs two inventories.

Role inventory. For each product, are you the manufacturer, importer, distributor, authorised representative, or another actor whose changes trigger manufacturer obligations? That answer determines which CRA articles apply to you 1.

Product inventory. For each product, record when and how it is supplied on the EU market; its software, hardware and cloud-service boundaries; intended and foreseeable connectivity; possible exclusions; your economic-operator role; its Annex III or IV classification; components and SBOM; support period; update mechanism; vulnerability-intake route; and the person responsible for CRA reporting 1.

A useful first CRA workshop does not start with a generic checklist. It starts with the product catalogue and the role map, then identifies which product lines need conformity planning, vulnerability-handling process design, and evidence discipline.

Where Cyvalent Can Help

Cyvalent 360 Cyber Services / CISOaaS provides the practitioner-led scoping work: role mapping, product inventory, CRA exposure assessment, product-class review against Annexes III and IV, and a practical evidence plan for design, vulnerability handling, and conformity-readiness work 1.

Cyvalent RGX maps CRA obligations to the control framework you already operate, such as ISO 27001, NIST CSF, or an internal secure-development framework. That makes evidence reuse visible: a secure-development process, vulnerability-management record, supplier-risk review, or access-control measure may support more than one regulatory or control-framework requirement.

The engagement output is a scoped operating view: which products appear relevant, which roles Cyvalent has identified for review, which CRA requirement areas need evidence, and how those requirements map to your existing control library.

In short

  • Software, connected hardware and components supplied separately may fall under the CRA when they are supplied on the EU market as part of a commercial activity and meet the connectivity test. Article 2 exclusions and the special treatment of open-source software still need to be checked [1].
  • Obligations are role-specific: manufacturers carry the primary design, risk-assessment, conformity, documentation, vulnerability-handling, reporting, and CE-marking duties (Article 13), while importers and distributors have their own checks (Articles 19-22).
  • The dates are already running: Article 14 vulnerability and incident reporting obligations apply from 11 September 2026 and the regulation applies fully from 11 December 2027 — so the first practical step is a role inventory and a product inventory.

Unsure whether the CRA applies to your product line?

Cyvalent helps product makers scope CRA exposure — role mapping, product inventory, product-class review, and a practical evidence plan — through founder-led 360 Cyber Services / CISOaaS and the Cyvalent RGX cyber GRC platform.

Frequently asked questions

Does the EU Cyber Resilience Act apply to my product?

Possibly. Check whether the product is supplied on the EU market as part of a commercial activity, whether it meets the CRA connectivity test, whether an exclusion applies and what role your business plays in the supply chain. The scope section above walks through each step [1].

What is a "product with digital elements" under the CRA?

Article 3 defines it as a software or hardware product and its remote data processing solutions, and Article 2 adds the connectivity test — a direct or indirect data connection to a device or network. Free and open-source software supplied outside a commercial activity falls outside the ordinary product rules, but monetised open-source components can be covered and qualifying open-source stewards have lighter, tailored duties [1].

How is the CRA different from NIS2 and DORA?

The legal trigger differs: NIS2 regulates the cybersecurity governance of organisations in listed sectors, DORA the operational resilience of financial entities, and the CRA products with digital elements on the EU market. A Luxembourg company may face CRA duties for a product while also falling under Luxembourg’s NIS2 Act or DORA for its own operations. For financial entities, however, DORA generally governs overlapping NIS2 cybersecurity risk-management and incident-reporting duties.

What does the CRA require manufacturers to do?

Follow the product lifecycle. Before market: a risk assessment, secure design, technical documentation and conformity assessment. At market: the EU declaration of conformity, CE marking, user information and a documented support period. After market: vulnerability handling, security updates, and reporting of actively exploited vulnerabilities and severe incidents through the CRA Single Reporting Platform. The depth of conformity assessment depends on whether the product is default, Important (Annex III) or critical (Annex IV).

When does the CRA take effect?

It is phased: the CRA entered into force in December 2024; the framework for notifying conformity-assessment bodies applies from 11 June 2026; Article 14 reporting from 11 September 2026; and the main obligations from 11 December 2027. Products placed on the market before 11 December 2027 generally meet the main requirements only on a substantial modification from that date (Article 69).

What should a product maker do first?

Build a role inventory (are you manufacturer, importer, distributor or authorised representative for each product?) and a product inventory covering EU-market supply, software/hardware/cloud boundaries, connectivity, exclusions, classification, components and SBOM, support period, update and vulnerability routes, and who owns CRA reporting. That worksheet tells you which product lines need conformity planning first — the “Your first step” section sets it out.

Sources & References

Last checked:

EU legislation

  1. [1] European Parliament & Council. Regulation (EU) 2024/2847 (Cyber Resilience Act) — Art. 2 (scope/connectivity and exclusions); Art. 3 definitions, incl. Art. 3(2) (remote data processing), Art. 3(22) and 3(48) (commercial supply and free/open-source definitions); Art. 13 (manufacturer obligations, incl. Art. 13(5)-(6) on open-source components and Art. 13(8)-(9) support period and update availability), Art. 14 (reporting from 11 Sep 2026), Arts. 19-22 (importer/distributor and related obligations), Art. 24 (open-source software stewards), Art. 25 (voluntary security attestation), Art. 28 (EU declaration of conformity), Art. 30 (CE marking), Art. 32(6) (reduced conformity-assessment fees for SMEs), Art. 33(5) (simplified technical-documentation form), Art. 64(10) (fine relief for micro and small enterprises), Art. 69 (transitional rules), Annex I (essential requirements and vulnerability handling, incl. SBOM), Annex III (important products in Classes I and II), Annex IV (critical product categories). Status/date: in force 10 Dec 2024; phased application to 11 Dec 2027. Source: EUR-Lex. https://eur-lex.europa.eu/eli/reg/2024/2847/oj

  2. [5] DORA. Regulation (EU) 2022/2554 and CSSF Luxembourg DORA overview — ICT risk management, incident reporting, resilience testing and ICT third-party risk for financial entities; CSSF and CAA are the Luxembourg competent authorities. Status/date: applicable from 17 Jan 2025. Sources: EUR-Lex and CSSF. https://eur-lex.europa.eu/eli/reg/2022/2554/oj and https://www.cssf.lu/en/ict-and-cyber-risk-for-dora-entities/

  3. [6] NIS2–DORA interaction — Directive (EU) 2022/2555 (NIS2) Article 4 and Regulation (EU) 2022/2554 (DORA) Article 1(2): where a sector-specific Union act such as DORA imposes at least equivalent ICT risk-management and reporting requirements, the corresponding NIS2 provisions do not apply; see the Commission's guidelines on the application of NIS2 Article 4. Status/date: guidelines OJ C, 18 Sep 2023. Sources: EUR-Lex and European Commission. https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX%3A52023XC0918%2801%29

EU implementation guidance

  1. [2] European Commission. Cyber Resilience Act — implementation guidance and FAQ — practical interpretation of scope, exclusions, open-source treatment and the requirement layers. Status/date: accessed July 2026. Source: European Commission. https://digital-strategy.ec.europa.eu/en/library/cyber-resilience-act-implementation-frequently-asked-questions

  2. [3] ENISA. CRA Single Reporting Platform — the single reporting platform for actively exploited vulnerabilities and severe incidents; early warning within 24 hours, notification within 72 hours, with separate final-report deadlines for vulnerabilities and incidents (from 11 Sep 2026). Status/date: accessed July 2026. Source: ENISA. https://www.enisa.europa.eu/topics/product-security-and-certification/single-reporting-platform-srp

Luxembourg authorities

  1. [4] Luxembourg NIS2. Loi du 5 mai 2026 concernant des mesures destinées à assurer un niveau élevé de cybersécurité (Mémorial A No 225) and ILR NIS2 overview — Luxembourg cybersecurity governance for in-scope organisations. Status/date: in force 10 May 2026. Sources: Legilux and ILR. https://legilux.public.lu/eli/etat/leg/loi/2026/05/05/a225/jo and https://www.ilr.lu/en/sectors/niss/nis-2/

  2. [7] Luxembourg CRA authority watch — ILNAS/OLAS and Ministry of the Economy. No official Luxembourg CRA market-surveillance or notifying-authority designation was identified as of 15 July 2026; ILNAS's 2025 report indicates the CRA market-surveillance functions expected to fall to it were still being developed. Verify Legilux and official ILNAS or Ministry of the Economy updates before naming an authority. Source: ILNAS. https://ilnas.public.lu/

Other Member State guidance

  1. [8] Optional implementation guidance from other Member States — Germany / BSI (Cyber Resilience Act information and TR-03183). This is guidance from another Member State's authority, offered only as optional context. Status/date: accessed July 2026. Source: BSI. https://www.bsi.bund.de/DE/Themen/Unternehmen-und-Organisationen/Informationen-und-Empfehlungen/Cyber_Resilience_Act/cyber_resilience_act_node.html

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