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The Cyber Resilience Act (CRA) is the European Union's most significant product security regulation since GDPR. Formally adopted as Regulation (EU) 2024/2847, the CRA establishes mandatory cybersecurity requirements for all products with digital elements sold in the EU market. Non-compliance carries penalties up to €15 million or 2.5% of global annual turnover, and products that fail conformity assessment lose EU market access entirely.
Unlike previous frameworks focused on organizational security practices, the EU CRA is product-centric. Every software product must demonstrate security throughout its lifecycle to receive CE marking CE Marking Overview. For security leaders, this regulation formalizes a long-standing principle: security must be considered at the design phase, not retrofitted after implementation. This guide explains what the CRA requires, who it affects, and how to build compliant practices.
What the EU CRA Regulates
Key Compliance Dates
Security by Design is the Essential New Mandate
What Organizations Must Do
The Cyber Resilience Act is an EU regulation establishing mandatory cybersecurity requirements for all products with digital elements sold in the European market. Formally adopted as Regulation (EU) 2024/2847 and entering into force on December 10, 2024, the CRA represents the most comprehensive product security regulation the EU has enacted.
Unlike previous cybersecurity frameworks that focused on organizational practices or specific sectors, the CRA is product-centric. It requires that every software product, from standalone applications to embedded firmware to SDK components, demonstrate security throughout its entire lifecycle, from initial design through end-of-life support EU Cyber Resilience Act Policy Page.
Product security failures have grown too consequential and too widespread for voluntary standards to address. When connected devices reach hundreds of millions of households and businesses, a single architectural shortcut can cascade into infrastructure-level disruption. As shown by the October 2016 Dyn attack, attackers compromised over 600,000 IoT devices by exploiting factory-made usernames and passwords, rendering services like Twitter, Netflix, GitHub, and others unreachable for hours.
The vulnerability was not a coding error that testing would have caught but a product design decision. Although GDPR addresses the handling of personal data and NIS2 addresses critical infrastructure network security, neither imposes obligations on the manufacturers whose design choices created the attack surface in the first place. The CRA fills this gap by making secure-by-design a legal requirement at the point of manufacture, documented and auditable before products reach the market Regulation (EU) 2024/2847.
The CRA differs from NIS2, DORA, and ISO 27001 in one key way: it regulates products, not organizations. While NIS2 requires essential service operators to implement security measures, and ISO 27001 certifies organizational security management systems, the CRA requires each individual product to meet specific security requirements and undergo conformity assessment before receiving CE marking for EU market access.
This product-level focus means compliance cannot be achieved through organizational policies alone. Each product requires documented evidence that security was considered and implemented throughout its development, starting at the design phase EU Cyber Resilience Act Policy Page.
The CRA follows a phased implementation timeline:
Why the September 2026 Deadline Matters:
While December 2027 is the full compliance deadline, September 2026 introduces mandatory vulnerability reporting. This means organizations need:
For companies selling to EU customers, this provides an implementation window to build the practices that form the foundation of CRA compliance, including design-stage security reviews CRA: Legal Implications and Risk Management.
The CRA establishes a tiered penalty structure based on violation severity CRA: Legal Implications and Risk Management:
Beyond financial penalties, non-compliance affects:
The CRA specifically calls out four classifications of software providers:
Organizations that design, build, or brand products bear primary responsibility for CRA compliance Regulation (EU) 2024/2847.
This includes:
Entities that bring products from outside the EU into the EU market must verify compliance before distribution Regulation (EU) 2024/2847.
Entities in the supply chain that make products available Regulation (EU) 2024/2847.
Open source software developed outside commercial activity is generally exempt Regulation (EU) 2024/2847.
However:
Does the CRA apply to companies outside the EU?
Yes. The CRA applies to any entity that places products with digital elements on the EU market, regardless of where that organization is headquartered. Non-EU manufacturers must comply with all essential requirements to receive CE marking and maintain EU market access EU Cyber Resilience Act Policy Page.
The CRA applies to products with digital elements (PDEs), defined as any software or hardware product that connects directly or indirectly to a device or network. The scope is deliberately broad to address the interconnected nature of modern digital products Regulation (EU) 2024/2847.
Pure SaaS offerings, where no software component is downloaded or installed, are generally excluded from the CRA's scope. However, most modern SaaS products include downloadable elements that bring them into scope EU Cyber Resilience Act Policy Page:
If your SaaS product includes any downloadable component, that component falls under CRA requirements, and the security of that component must be demonstrated through design-stage practices EU Cyber Resilience Act Policy Page.
The CRA establishes risk categories with corresponding compliance requirements:
What is required for CRA conformity assessment?
CRA conformity assessment requirements depend on product risk classification. Default (non-critical) products allow self-assessment. Important Class I products can self-assess with harmonized standards or use third-party assessment. Important Class II products require mandatory third-party assessment by notified bodies. Critical products require European cybersecurity certification Regulation (EU) 2024/2847.
The CRA's essential requirements are defined in Annex I of the regulation and are divided into two categories: security requirements for the product itself, and vulnerability handling requirements for ongoing support Regulation (EU) 2024/2847.
1. Security by Design
Products must be "designed, developed and produced" with appropriate cybersecurity levels based on risk assessment. This requires documented evidence that security was considered during architectural decisions, not added after implementation. The regulation states:
"Products with digital elements shall be designed, developed and produced in such a way that they ensure an appropriate level of cybersecurity based on the risks." (CRA Annex I, Section 1.1) Regulation (EU) 2024/2847
2. Secure Default Configuration
Products must ship with secure settings by default: least-privilege access, no default credentials, and hardened configurations aligned to intended use. Configurations that require user action to become secure do not meet this requirement EU Cyber Resilience Act Policy Page.
3. Data Protection
Products must ensure confidentiality, integrity, and availability of data through appropriate mechanisms including encryption, access controls, and data minimization EU Cyber Resilience Act Policy Page.
4. Resilience and Availability
Products must resist denial-of-service attacks and minimize negative impacts on other network resources EU Cyber Resilience Act Policy Page.
5. Attack Surface Minimization
Products must minimize external interfaces, disable unnecessary services, and limit the impact of potential compromises through segmentation and containment EU Cyber Resilience Act Policy Page.
6. Software Bill of Materials (SBOM)
Manufacturers must identify and document all software components, including dependencies, in a machine-readable format, SPDX or Cyclone DX (SPDX Specification or CycloneDX Project).
The CRA's most consequential requirement is not SBOM generation or vulnerability scanning. It is the mandate for security by design. Article 13 requires manufacturers to "exercise due diligence when integrating components" and ensure products are "designed, developed and produced in accordance with essential requirements." The regulation specifies:
"Manufacturers should therefore ensure that all products with digital elements are designed and developed in accordance with the essential cybersecurity requirements laid down in this Regulation." (CRA (9)) Regulation (EU) 2024/2847
Security by design under the CRA means integrating security considerations from the earliest product development phases, during architectural decisions and feature design, not retrofitting security after implementation. The regulation requires documented evidence that security was considered during design, not just tested after development EU Cyber Resilience Act Policy Page.
"Products with digital elements shall be designed, developed and produced in such a way that they ensure an appropriate level of cybersecurity based on the risks." (CRA Annex I) Regulation (EU) 2024/2847
We continue to see an acceleration in the amount of focus that the design stage is getting from a cybersecurity risk management perspective from not only this act alone, but from global cybersecurity organizations MITRE Application Developer Guidance and regulators alike ENISA Threat Landscape 2025.
Most organizations have to this point invested substantially in code-level security tools:
These tools serve important purposes, but they operate after code exists.
The CRA asks a different question: What security decisions were made when this feature was designed?
When a feature moves from specification to implementation, the security-relevant decisions happen early. What data will this access? How will authentication work? What happens if this component is compromised? By the time code exists to scan, these architectural decisions are already made.
Answering the CRA's design-stage question requires security review during the design phase, with documented evidence that can satisfy conformity assessment. This creates a gap for most organizations: they have tooling for code-level security, but not for design-stage security review EU Cyber Resilience Act Policy Page.
The CRA creates new compliance obligations that existing tools and regulations do not address:
These security-by-design requirements create the primary compliance gap organizations must close Regulation (EU) 2024/2847.
Prime Security's Agentic Security Architect addresses the design-stage gap by bringing security review to where the CRA requires it: before code is written. Prime identifies security risks in planned work and creates the documented evidence that conformity assessment requires.
Prime analyzes feature specifications, architectural decisions, and integration plans as they are created, not after they are implemented.
When a developer writes a Jira ticket describing a new feature, Prime automatically:
This shifts security review to where the CRA requires it, the design phase, while ensuring consistent coverage across all development activity.
Manual security design reviews can satisfy CRA requirements in theory. In practice, they create an impossible tradeoff. The CRA demands documented security consideration for every feature across every product. Achieving full coverage manually means either hiring a security architect for every development team or slowing releases to a crawl while a small team reviews everything. Most organizations end up with partial coverage and gaps in their conformity documentation IBM Secure by Design, with AI 2025.
Prime resolves this tradeoff. By automating design-stage review, organizations achieve the continuous coverage CRA requires without blocking development. Security teams maintain oversight and make final decisions, but the baseline analysis and documentation happens automatically, at the pace of development.
Security by Design (Annex I, Part I)
The CRA requires that products "be designed, developed and produced in such a way that they ensure an appropriate level of cybersecurity based on the risks."
Prime ensures that security teams are able appropriately manage the risks of every project by making sure that features are designed securly from the beginning.
Risk Assessment (Statement 37))
The CRA also mandates that “ Manufacturers should ensure that software made available under those conditions is released only following a risk assessment and that it complies to the extent possible with the security requirements relating to the properties of products with digital elements laid down in this Regulation.”
Prime's agent assesses the risk of both new components and existing software based on the rules and regulations set out by each individual company, regardless of size or industry..
Due Diligence on Components (Article 13.5)
The regulation requires manufacturers to "exercise due diligence when integrating components sourced from third parties."
When development plans include third-party integrations, Prime analyzes the security implications of those integrated design decisions.
Effective and Regular Testing (Annex I, Part II)
The CRA mandates that manufacturers "apply effective and regular tests and reviews of the security of the product."
Prime fits into your existing workflows between security and engineering, continuously reviewing development activity.
Technical Documentation (Article 31)
“The technical documentation shall contain all relevant data or details of the means used by the manufacturer to ensure that the product with digital elements and the processes put in place by the manufacturer comply with the essential cybersecurity requirements set out in Annex I.”
Prime creates persistent, auditable records of security decisions, recommendations, and reviews, producing the documentation required for conformity assessment and market surveillance.
NIS2 (Directive 2022/2555) applies to essential and important entities operating critical infrastructure and requires organizational security measures, incident reporting, and supply chain security. The CRA applies to products regardless of who uses them NIS2 Directive (EU) 2022/2555.
The key differences:
Most organizations that need to comply with NIS2 will also need to comply with CRA. A software company providing products to healthcare organizations might need NIS2 compliance as an important entity and CRA compliance for each product sold.
The Digital Operational Resilience Act (DORA) focuses on financial entities with requirements for ICT risk management, incident reporting, and third-party risk management.
While DORA regulates organizational resilience; CRA focuses on product security. Financial services companies subject to DORA that also manufacture software products need CRA compliance for those products in addition to DORA compliance for their operations DORA Regulation (EU) 2022/2554.
ISO 27001 is a voluntary certification for information security management systems. The CRA is mandatory regulation with legal enforcement. ISO 27001 certification can support CRA compliance by demonstrating mature security practices, but does not substitute for product-level conformity assessment and technical documentation ISO/IEC 27001:2022.
The Cyber Resilience Act formalizes what security teams have long advocated: security consideration at the design phase, with documented evidence. The regulation provides clear requirements and a defined timeline to build out security by design best practices. Prime Security addresses the design-stage challenge by bringing automated security review to the design phase, creating the documented evidence that conformity assessment requires while helping your security architects focus on the strategic decisions that need human judgment iapp Guide to EU CRA Compliance.
Request a Demo to see how Prime Security automates CRA-compliant security design reviews across your development organization.