What is the EU Cyber Resilience Act (CRA)?

The EU Cyber Resilience Act (CRA), officially EU Regulation 2024/2847, is a comprehensive EU regulation that establishes mandatory cybersecurity requirements for products with digital elements sold in the European Union. It applies to hardware and software products that can connect to networks or process data. The CRA aims to ensure that manufacturers, importers, and distributors maintain security throughout a product's lifecycle, including vulnerability management, security updates, and transparent communication with users. Full enforcement begins December 11, 2027.

Does the CRA apply to SaaS (Software as a Service) products?

Yes, the CRA applies to most SaaS products. The regulation covers 'products with digital elements' which includes software that processes data or connects to networks. Cloud-based SaaS applications fall under this definition if they are sold or made available to EU customers. However, not all 22 CRA requirements apply to every SaaS product—typically 8-12 requirements apply to cloud-only B2B SaaS, while IoT products may need to comply with all 22. Use the free CRA Compliance Toolkit at cra-toolkit.com to determine which specific requirements apply to your product.

What are the main CRA requirements for software products?

The main CRA requirements for software products include: 1) Secure by Design (Article 10.1) - integrating security throughout development, 2) Secure by Default (Article 10.2) - shipping with secure default configurations, 3) Software Bill of Materials/SBOM (Article 10.5) - maintaining a list of all software components, 4) Vulnerability Handling (Article 13) - having a process to receive and address security vulnerabilities, 5) Security Updates (Article 10.4) - providing security updates for at least 5 years or the product's expected lifetime. Additional requirements may apply based on your specific product type and classification.

When does CRA enforcement begin and what are the key deadlines?

The CRA enforcement happens in phases: 1) December 10, 2024 - CRA enters into force, 2) September 11, 2026 - Conformity assessment bodies must be designated, 3) September 11, 2026 - Vulnerability and incident reporting obligations begin, 4) December 11, 2027 - Full enforcement of all requirements. Organizations selling products with digital elements in the EU should begin compliance preparations now to meet these deadlines.

What is an SBOM and why does CRA require it?

An SBOM (Software Bill of Materials) is a comprehensive list of all software components, libraries, and dependencies used in a product—like an ingredients list for software. CRA Article 10.5 requires manufacturers to maintain SBOMs because: 1) It enables rapid identification of affected products when vulnerabilities are discovered (e.g., Log4j), 2) It provides transparency about third-party components and their security status, 3) It supports vulnerability management and incident response. Free tools like CycloneDX, Syft, and Trivy can generate SBOMs automatically from your codebase.

How much does CRA compliance cost?

CRA compliance costs vary significantly: Hiring consultants typically costs €8,000-€15,000 for initial assessment and €20,000-€50,000+ for full implementation support. However, DIY compliance is possible at minimal cost using free, open-source tools: CycloneDX for SBOM generation, OWASP Dependency-Track for vulnerability monitoring, Trivy for container scanning, and Semgrep for static analysis. The free CRA Compliance Toolkit at cra-toolkit.com helps identify which requirements apply to your product, potentially saving thousands in unnecessary consultant fees. Additionally, EU SMEs can apply for up to €30,000 in grants through the SECURE/Secure4sme program (50% co-financing).

Is my US-based company affected by the CRA?

Yes, if your US-based company sells products with digital elements to customers in the European Union, the CRA applies to you. The CRA has extraterritorial reach—it applies based on where products are sold, not where the company is based. If you place products on the EU market (even through distributors or resellers), you must comply with CRA requirements. This is similar to how GDPR applies to non-EU companies that process EU residents' data.

What products are exempt from CRA?

Several categories are exempt from CRA: 1) Internal tools not placed on the market, 2) Custom software developed for a single client, 3) Products already regulated under other EU frameworks (medical devices, vehicles, aviation), 4) National security and military products, 5) Open-source software developed non-commercially by individuals or non-profit foundations (though commercial entities using open-source remain liable). SaaS products serving only internal company use would not be in scope, but any product offered to external EU customers likely falls under CRA.

What is the difference between CRA and NIS2?

CRA and NIS2 are complementary EU regulations with different focuses: CRA (Cyber Resilience Act) focuses on PRODUCT security—ensuring hardware and software products sold in the EU are secure by design. NIS2 (Network and Information Security Directive 2) focuses on ORGANIZATIONAL security—requiring essential and important entities to implement cybersecurity measures and report incidents. A company might need to comply with both: NIS2 for their organizational security practices, and CRA for any products they manufacture and sell. CRA has specific technical requirements (SBOM, vulnerability handling), while NIS2 focuses on governance, risk management, and incident reporting.

How do I check if CRA applies to my product?

To check if CRA applies to your product, ask these questions: 1) Do you sell or make your product available in the EU market? 2) Is your product software or hardware that processes data or connects to networks? 3) Are you the manufacturer (creator/seller) of the product? If you answered YES to all three, CRA likely applies. The free CRA Compliance Toolkit at cra-toolkit.com provides a 5-minute assessment that determines exactly which of the 22 CRA requirements apply to your specific product type, saving you hours of research through the 200+ page regulation.

What are the CRA penalties for non-compliance?

CRA penalties can be severe: up to €15 million or 2.5% of global annual turnover (whichever is higher) for violations of essential cybersecurity requirements. For less severe infringements, fines can reach €10 million or 2% of turnover. Providing misleading information to authorities can result in fines up to €5 million or 1% of turnover. Additionally, non-compliant products can be withdrawn from the EU market entirely, resulting in significant revenue loss beyond the fine itself.

What is a Software Bill of Materials (SBOM) and how do I create one for CRA?

A Software Bill of Materials (SBOM) is a comprehensive inventory of all software components, libraries, and dependencies in your product — like an ingredients list for software. CRA Article 10.5 requires manufacturers to create and maintain SBOMs. You can generate one for free using tools like CycloneDX CLI, Syft, or Trivy. The SBOM should include component names, versions, suppliers, and known vulnerabilities. Integrate SBOM generation into your CI/CD pipeline for automatic updates. The free CRA Compliance Toolkit at cra-toolkit.com/cra-sbom-requirements provides detailed guidance.

Does the CRA apply to open-source software?

It depends. Non-commercial open-source software developed by individuals or non-profit foundations is generally exempt from CRA. However, commercial entities that use, integrate, or distribute open-source software in their products remain fully liable under CRA for those products. Additionally, the CRA introduces a new category called open-source software stewards (Article 24) — organizations that systematically support open-source projects used commercially. Stewards have reduced obligations focused on cybersecurity policies and cooperation with authorities, but they are not exempt entirely. Learn more at cra-toolkit.com/cra-for-stewards.

How does CRA affect companies outside the EU?

The CRA has extraterritorial reach, similar to GDPR. If your company — regardless of where it is headquartered (US, UK, India, etc.) — sells or makes available products with digital elements to customers in the EU market, you must comply with CRA requirements. This applies whether you sell directly or through distributors, resellers, or app stores. Companies outside the EU should designate an authorized representative within the EU and begin compliance preparations well before the December 2027 full enforcement deadline. Use the free assessment at cra-toolkit.com/does-cra-apply-to-me to check your obligations.

Industry Guide Updated: August 2026

Does the Cyber Resilience Act Apply to Healthtech Apps?

Learn if the EU CRA applies to Healthtech Apps, what the core compliance requirements are, and how to start preparing your engineering teams automatically.

Core Definition

Yes. The EU Cyber Resilience Act applies directly to Healthtech Apps as they fall under the definition of "products with digital elements." A symptom-checker app not classified as a medical device under the MDR is squarely in CRA scope even though it handles health data. This means your software must meet mandatory cybersecurity requirements to be distributed in the EU market.

Key Compliance Steps for Healthtech Apps

Determine Classification: Check if your Healthtech Apps falls under the default category, an important class (Annex III, class I or II) or the critical list (Annex IV), which dictate stricter conformity assessment paths.
Perform Risk Assessment: Map out the attack surface for your software and document the mitigations for the "secure by design" requirement.
Implement Vulnerability Reporting: Provide a 24-hour reporting mechanism to ENISA for actively exploited vulnerabilities.
Generate an SBOM: Ensure all dependencies used in your Healthtech Apps are documented in a machine-readable Software Bill of Materials.
Avoid the Common Pitfall: Assuming any app touching health data automatically falls under MDR — most consumer wellness apps don't.

How This Plays Out in Practice

A symptom-checker app not classified as a medical device under the MDR is squarely in CRA scope even though it handles health data.

What to Watch For

Assuming any app touching health data automatically falls under MDR — most consumer wellness apps don't.

Common Questions

Which Annex I points apply to an app that stores health data?

Where applicable, Annex I Part I, points (2)(e) and (2)(f) require protecting the confidentiality and integrity of stored, transmitted or otherwise processed data, and point (2)(m) requires giving users the possibility to securely and easily remove on a permanent basis all data and settings.

What vulnerability-handling duties come with it?

Annex I Part II, points (5) and (6) require a policy on coordinated vulnerability disclosure and a contact address for reporting vulnerabilities, and Annex II, point 2 lists the single point of contact among the information that must accompany the product.

Assess Your CRA Readiness

Evaluate your product's Cyber Resilience Act readiness using our interactive tool. Find exactly which of the 22 security requirements apply directly to Healthtech Apps.

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