Understanding the newly enacted EU cyber resilience act (CRA)

Understanding the newly enacted EU cyber resilience act (CRA)

The European Union's Cyber Resilience Act, proposed in September 2022 and enacted on October 14th, marks a watershed moment in cybersecurity regulation. The legislation establishes comprehensive requirements for products “with digital elements” in response to the escalating challenges of cybersecurity. This article examines the Act's scope, requirements, and implications for stakeholders across the digital ecosystem.

What are the background and objectives?

The digital landscape has witnessed unprecedented growth in connected devices and systems, bringing both opportunities and vulnerabilities. Recent years have seen devastating cyberattacks, including the well-known WannaCry ransomware and the Kaseya supply chain attack. These incidents have demonstrated the urgent need for a unified approach to cybersecurity regulation across the European Union.

Prior to the CRA, the regulatory landscape was fragmented, with inconsistent standards across member states creating confusion for businesses and obstacles for consumers. The Act establishes “horizontal cybersecurity requirements” to promote a single framework for digital product security across the European Single Market.

The first objective focuses on enhancing the security of products with digital elements by minimizing vulnerabilities in both hardware and software and embedding security as a priority throughout the product lifecycle. This approach ensures that security considerations are integral from development to deployment and beyond. The second objective emphasizes empowering users to make informed cybersecurity decisions by fostering awareness and providing tools or information to evaluate and prioritize security when selecting and using digital products. Together, these objectives aim to create a comprehensive framework for secure product development and informed user engagement.

What are the scope and applicability of the regulation?

Under the Cyber Resilience Act (CRA), a “product with digital elements” is defined as a software or hardware product, along with its remote data processing solutions, including any software or hardware components that are placed on the market separately. This broad definition encompasses a wide range of digital goods, from standalone software and hardware devices to systems reliant on external or cloud-based processing functionalities.

*Remote data processing refers to solutions where data is managed or processed remotely, typically via cloud computing or external servers, as an integral part of the functionality of the product with digital elements. 

The CRA specifies several exclusions to its scope:

Products already regulated by specific EU frameworks - the CRA does not apply to products governed by sector-specific regulations that address equivalent or higher cybersecurity standards, such as:

  • Regulation (EU) 2017/745 on medical devices, Regulation (EU) 2017/746 on in vitro diagnostic devices,

  • Regulation (EU) 2019/2144 on the general safety of motor vehicles,
  • Regulation (EU) 2018/1139 on civil aviation safety (for products certified under this framework),
  • Specialized equipment and national security;
  • Products falling within the scope of Directive 2014/90/EU on marine equipment;
  • Products developed or modified exclusively for national security or defense purposes or specifically designed to process classified information.

Spare parts for identical component replacement - the CRA does not apply to spare parts that are made available on the market for replacing identical components in products with digital elements, provided they are manufactured to the same specifications as the original components;

Overlapping or equivalent regulatory frameworks - the CRA allows for certain products with digital elements covered by other EU rules to be excluded or limited in their applicability under the CRA, provided:

The European Commission retains the authority to specify such exclusions via delegated acts, ensuring a harmonized approach while avoiding duplication of regulations. Obligations under the CRA do not require entities to disclose information that could compromise national security, public security, or other essential state interests.


What are the main requirements?

The CRA establishes fundamental obligations for manufacturers throughout the product lifecycle. During the design and development phase, manufacturers must implement security-by-design principles, conduct thorough risk assessments, and ensure secure default configurations. Technical documentation must detail these security measures to provide transparency and accountability.

Post-market obligations form a crucial component of the framework: manufacturers must maintain active vulnerability monitoring systems, provide timely security updates, and establish clear channels for incident reporting. These requirements extend protection beyond the point of sale and address the dynamic nature of cybersecurity threats.

Consumers gain substantial benefits from the new framework. Transparent security information enables informed purchasing decisions, while mandatory update requirements ensure ongoing protection.

For manufacturers, the Act’s requirements ripple through supply chains, affecting component manufacturers, importers, and distributors. Organizations must establish robust systems for assessing supplier compliance and maintaining documentation throughout the supply chain.

Organizations should approach compliance strategically, beginning with a comprehensive assessment of their product portfolios and security measures. Establishing robust documentation systems and developing internal expertise are crucial for successful implementation. Regular monitoring and updates ensure ongoing compliance as requirements and threats evolve.


What is the conformity assessment framework?

The Act introduces a risk-based classification system for digital products:

  • Class I products, representing standard risk levels, may undergo self-assessment procedures with internal controls.
  • Class II products, designated as critical due to their potential impact on security, require third-party assessment and enhanced testing protocols.

The assessment relies on rigorous and comprehensive documentation, including technical specifications, risk analyses, and test results.


What is the timeline?

Implementation follows a measured timeline, with a 24-month transition period following adoption. This phased approach allows stakeholders to adapt their processes and systems to meet new requirements. The European Union Agency for Cybersecurity (ENISA) plays a central role in coordinating implementation, providing guidance, and fostering collaboration among national authorities.


What are the enforcement mechanisms?

National authorities, working in coordination with ENISA, hold primary responsibility for enforcement. These bodies possess broad powers to request documentation, conduct inspections, and order corrective measures when necessary. The penalty framework includes administrative fines and market restrictions, ensuring effective deterrence while maintaining proportionality.

The CRA creates significant implications for the European digital market. While implementation requires substantial investment from manufacturers, particularly in documentation systems and security measures, these costs are offset by the benefits of market harmonization and enhanced consumer trust.

The unified regulatory framework reduces compliance complexity for manufacturers operating across multiple member states. Furthermore, enhanced security standards strengthen the competitive position of European products in the global market, where cybersecurity increasingly influences purchasing decisions.


Conclusion

The Cyber Resilience Act marks a significant advancement in cybersecurity regulation and establishes comprehensive requirements for digital product security. While implementation presents challenges, the benefits of enhanced security, market harmonization, and consumer trust were the main motivations behind this regulation. Compliance success demands proactive engagement from all stakeholders, from manufacturers to regulatory authorities, and an exceptional effort in cybersecurity development and documentation.

The Act positions the EU as a global leader in cybersecurity regulation, potentially influencing standards worldwide. Nevertheless, the CRA represents a foundation for evolving cybersecurity regulation. As technology advances and threats evolve, the framework will likely require updates and refinements.

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