EU: Cyber Resilience Act published in EU Official Journal

By Rachel de Souza & Philipp Adelberg on November 21, 2024

Posted in Cyber security, Digital Decade, Digital transformation, EU data governance, EU privacy, New laws

On 20 November 2024, the EU Cyber Resilience Act (CRA) was published in the Official Journal of the EU, kicking off the phased implementation of the CRA obligations.

What is the CRA?

The CRA is a harmonising EU regulation, the first of its kind focusing on safeguarding consumers and businesses from cybersecurity threats. It is a key element of the EU’s Cybersecurity Strategy for the Digital Decade.

The CRA is designed to fulfil a perceived gap in EU regulation and sets uniform cybersecurity standards for the design, development and production of hardware and software products with digital elements (PDEs) placed on the EU market – introducing mandatory requirements (e.g. relating to security vulnerabilities, and addressing transparency) for manufacturers and retailers, extending throughout the product lifecycle. With few exceptions for specific categories, the CRA covers all products connected directly or indirectly to other devices or networks.

Scope of the CRA

The CRA applies to all economic operators of PDEs made available on the EU market. This includes:

manufacturers (and their authorised representatives);
importers;
distributors; and
any other natural or legal person subject to obligations in relation to the manufacture of PDEs or making them available on the market (including retailers).

The reach of the proposed CRA is broad, covering all PDEs whose intended and reasonably foreseeable use includes a direct or indirect logical or physical data connection to a device or network.

A PDE is defined as “any software or hardware product and its remote data processing solutions, including software or hardware components to be placed on the market separately” (Article 3(1) CRA).

Remote data processing is defined as “any data processing at a distance for which the software is designed and developed by the manufacturer or under the responsibility of the manufacturer, and the absence of which would prevent the product with digital elements from performing one of its functions” (Article 3(2) CRA).

Whilst the usual example of in-scope products is smart devices, such as smartphones, this is complicated in respect of software products involving remote data processing solutions: the CRA supporting FAQ indicates that software which forms part of a service rather than a product is not intended to be covered.

It is therefore important to identify how products are provided – as software products with remote data solutions, or software which is part of a service. This analysis will need to take into account how the various ‘features’ making up each product are provided.

Manufacturers are broadly defined as “any natural or legal person who develops or manufactures products with digital elements or has products with digital elements designed, developed or manufactured, and markets them under his or her name or trademark, whether for payment or free of charge” (Article 3(13) CRA).

Exceptions:

The CRA excludes from its scope a limited number of products and/or fields which are considered to be already sufficiently regulated, including:

Products which are in conformity with harmonised standards and products certified under an EU cybersecurity scheme; and
Medical devices, aviation devices, and certain motor vehicle systems/components/technical units, to which existing certification regimes apply.

Obligations of economic operators

The primary objective of the CRA is to address a perception at EU institutional level of a poor level of cybersecurity and vulnerabilities in many software and hardware products on the market. The CRA also aims to address the lack of comprehensive information on the cybersecurity properties of digital products to enable consumers to make more informed choices when buying products. With this in mind, the CRA imposes a large number of obligations upon relevant economic operators, with the majority of obligations falling on “manufacturers” of PDEs.

Key obligations on manufactures under the CRA include:

When placing a PDE on the EU market, ensuring that it has been designed, developed and produced in accordance with the essential requirements set out in Section 1 of Annex I CRA. The high level requirements set out in Annex 1, Part 1 CRA, include that products with digital elements “shall be designed, developed and produced in such way that they ensure an appropriate level of cybersecurity”, to ensure protection from unauthorised access by appropriate control mechanisms, and protect the confidentiality and integrity of stored, transmitted or otherwise processed data; to be designed, developed and produced to limit attack surface, including external interfaces. These requirements may be clarified as the European Commission is authorised to adopt implementing acts establishing common specifications covering technical requirements that provide a means to comply with the essential requirements set out in Annex 1 CRA;
Undertake an assessment of the cybersecurity risks associated with a PDE, taking the outcome of that assessment into account during the planning, design, development, production, delivery and maintenance phases of the PDE, with a view to minimising cybersecurity risks, preventing security incidents and minimising the impacts of such incidents, including in relation to the health and safety of users;
Document and update the assessment of the cybersecurity risks associated with a PDE and take the outcome of that assessment into account during the planning, design, development, production, delivery and maintenance phases of the product with digital elements;
Exercise due diligence when integrating components sourced from third parties in PDEs and ensure that such components do not compromise the security of the PDE;
Document relevant cybersecurity aspects concerning the PDE, including vulnerabilities and any relevant information provided by third parties, and, where applicable, update the risk assessment of the product;
Put in place compliant vulnerability handling processes, including providing relevant security updates, for the duration of the support period (of, in principle, five years);
Report actively exploited vulnerabilities to the relevant Computer Security Incident Response Team (CSIRT) and the EU Agency for Cybersecurity (ENISA) without undue delay and in any event within 24 hours of becoming aware. The manufacturer must also inform the impacted users of the PDE (and, where appropriate, all users) in a timely manner about an actively exploited vulnerability or a severe incident and, where necessary, about risk mitigation and any corrective measures that they might deploy to mitigate the impact;
Perform (or have performed) a conformity assessment for PDEs to demonstrate compliance with obligations. Depending on the risk classification of the product in question there are different procedures and methods that may be applied, with products considered to be of particular high risk being subject to stricter requirements. The procedures range from internal control measures to full quality assurance, with more stringent provisions introduced for products deemed “critical”, such as web browsers, firewalls, password managers (designated class I) and operating systems, CPUs (designated class II). These products will have to undergo specific conformity assessment procedures carried out by notified third-party bodies. For each of these procedures, the CRA contains checklists with specifications that must all be met in order to successfully pass. Manufactures must also draw up an EU declaration of conformity and affix a CE marking to the product; and
Ensure that PDEs are accompanied by information, such as the manufacturer’s details and point of contact where vulnerabilities can be reported, and detailed instructions for users including how security updates can be installed and how the product can be securely decommissioned.

Importers and Distributors

The above obligations primarily fall upon manufacturers. However importers and distributors of these products are subject to related obligations regarding those processes, including, only placing on the market PDEs that comply with the essential requirements set out under the law; ensuring that the manufacturer has carried out the appropriate conformity assessment procedures and drawn up the required technical documentation; and that PEDs bear the CE marking and is accompanied by required information for users. Where an importer or distributor identifies a vulnerability in a PDE, it must inform the manufacturer without undue delay, and must immediately inform market surveillance authorities where a PDE presents a “significant cybersecurity risk.”

Overlap with other EU Legislation

The CRA FAQ states that the Act aims to “harmonise the EU regulatory landscape by introducing cybersecurity requirements for products with digital elements and avoid overlapping requirements stemming from different pieces of legislation”. The application of the CRA is subject to certain exclusions where relevant PDEs are already covered by certain regulations – such as the NIS2 Directive and the AI Act (which are considered lex specialis to the CRA as lex generalis). In relation to high-risk AI systems, for example, the CRA explicitly provides that PDEs that also qualify as high-risk AI systems under the AI Act will be deemed in compliance with the AI Act’s cybersecurity requirements where they fulfil the corresponding requirements of the CRA. The listed regulations do not include DORA (Regulation 2022/2554), so there is the potential for overlap for those caught by DORA.

However, Article 2(4) CRA indicates that the application of the CRA may be limited or excluded where PDEs are covered by other Union rules laying down requirements addressing some or all of the risk covered by the essential requirements set out in Annex 1 CRA, in a manner consistent with the applicable regulatory framework, and where the sectoral rules achieve the same or a higher level of protection as that provided under the CRA.

The European Commission may also use its powers to adopt delegated acts in order to further clarify such limitations or exclusions, but in the absence of such delegated acts, the scope is somewhat unclear in respect of financial services entities, given the overlap with DORA.

Enforcement

The CRA provides for extensive participation by public authorities. Accordingly, the European Commission, ENISA and national authorities are granted comprehensive market monitoring, investigative and regulatory powers. For cross-border matters, the CRA also addresses the different procedures and principles for these authorities to cooperate with each other if disagreements arise in the interpretation and application of the law.

Authorities are also provided with the power to carry out so-called “sweeps”. Sweeps will be unannounced and coordinated, involving area-wide monitoring and control measures that are intended to provide information as to whether or not the requirements of the CRA are being complied with. It is particularly important to note that sweeps may apparently be carried out simultaneously by several authorities in close coordination, thus enabling the investigation of cross-border matters.

The CRA provides for a phased concept of administrative fines for non-compliance with certain legal requirements, which follows the model of recent European legislation and is intended primarily as a deterrent:

Breaches of the essential cybersecurity requirements, conformity assessment and reporting obligations may result in administrative fines of up to EUR 15 million or up to 2.5% of annual global turnover, whichever is higher.

Breaches of the other CRA rules, including requirements to appoint an authorised representative, obligations applicable to importers or distributors, and certain requirements for the EU declaration of conformity, technical documentation and CE marking, may result in administrative fines of up to EUR 10 million or up to 2% of annual global turnover, whichever is higher.

Organisations which provide incorrect, incomplete or misleading information face administrative fines of up to EUR 5 million or, if the offender is an undertaking, up to 1% of annual turnover.

When deciding on the amount of the administrative fine in each individual case, all relevant circumstances of the specific situation should be taken into account, including the size and market share of the operator committing the infringement.

Non-compliance with CRA requirements may also result in corrective or restrictive measures, including the Market Surveillance Authorities or the Commission recalling or withdrawing products from the EU market.

As the methods for imposing administrative fines will be left to Member States to implement, there is the risk of significant legal uncertainty in relation to enforcement. Although the CRA specifies certain parameters, in particular criteria for the calculation of administrative fines, the proposed regulation raises concerns with regard to the uniform interpretation and application of the rules on administrative fines throughout the EU.

Next procedural steps

The CRA provides for a phased transition period, with the provisions on notification of conformity assessment bodies (Chapter VI) applying from 11 June 2026, and the reporting obligations for manufacturers taking effect from 11 September 2026. The remaining obligations will come into effect on 11 December 2027.

The CRA is likely to present significant challenges for many companies. It is important that those entities falling within the scope of the CRA start preparing for its implementation. Manufacturers should assess current cybersecurity measures against the upcoming requirements to identify potential compliance gaps and start planning compliance strategies early, including understanding the requirements relating to conformity assessments; technical documentation; and new incident reporting requirements.

Please reach out to your usual DLA Piper contact if you would like to discuss further.