CRA Article 2. Scope

Under certain conditions, all products with digital elements integrated in or connected to a larger electronic information system can serve as an attack vector for malicious actors. As a result, even hardware and software considered to be less critical can facilitate the initial compromise of a device or network, enabling malicious actors to gain privileged access to a system or to move laterally across systems. 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. That obligation relates to both products that can be connected physically via hardware interfaces and products that are connected logically, such as via network sockets, pipes, files, application programming interfaces or any other types of software interface. As cyber threats can propagate through various products with digital elements before reaching a certain target, for example by chaining together multiple vulnerability exploits, manufacturers should also ensure the cybersecurity of products with digital elements that are only indirectly connected to other devices or networks.

Cloud solutions constitute remote data processing solutions within the meaning of this Regulation only if they meet the definition laid down in this Regulation. For example, cloud enabled functionalities provided by a manufacturer of smart home devices that enable users to control the device at a distance fall within the scope of this Regulation. On the other hand, websites that do not support the functionality of a product with digital elements, or cloud services designed and developed outside the responsibility of a manufacturer of a product with digital elements do not fall within the scope of this Regulation. Directive (EU) 2022/2555 applies to cloud computing services and cloud service models, such as Software as a Service (SaaS), Platform as a Service (PaaS) or Infrastructure as a Service (IaaS). Entities providing cloud computing services in the Union which qualify as medium-sized enterprises under Article 2 of the Annex to Recommendation 2003/361/EC, or exceed the ceilings for medium-sized enterprises provided for in paragraph 1 of that Article, fall within the scope of that Directive.

This Regulation applies to economic operators only in relation to products with digital elements made available on the market, hence supplied for distribution or use on the Union market in the course of a commercial activity. Supply in the course of a commercial activity might be characterised not only by charging a price for a product with digital elements, but also by charging a price for technical support services where this does not serve only the recuperation of actual costs, by an intention to monetise, for instance by providing a software platform through which the manufacturer monetises other services, by requiring as a condition for use the processing of personal data for reasons other than exclusively for improving the security, compatibility or interoperability of the software, or by accepting donations exceeding the costs associated with the design, development and provision of a product with digital elements. Accepting donations without the intention of making a profit should not be considered to be a commercial activity.

Products with digital elements provided as part of the delivery of a service for which a fee is charged solely to recover the actual costs directly related to the operation of that service, such as may be the case with certain products with digital elements provided by public administration entities, should not be considered on those grounds alone to be a commercial activity for the purposes of this Regulation. Furthermore, products with digital elements which are developed or modified by a public administration entity exclusively for its own use should not be considered to be made available on the market within the meaning of this Regulation.

The sole act of hosting products with digital elements on open repositories, including through package managers or on collaboration platforms, does not in itself constitute the making available on the market of a product with digital elements. Providers of such services should be considered to be distributors only if they make such software available on the market and hence supply it for distribution or use on the Union market in the course of a commercial activity.

Regulation (EU) 2017/745 of the European Parliament and of the Council lays down rules on medical devices and Regulation (EU) 2017/746 of the European Parliament and of the Council lays down rules on in vitro diagnostic medical devices. Those Regulations address cybersecurity risks and follow particular approaches that are also addressed in this Regulation. More specifically, Regulations (EU) 2017/745 and (EU) No 2017/746 lay down essential requirements for medical devices that function through an electronic system or that are software themselves. Certain non-embedded software and the whole lifecycle approach are also covered by those Regulations. Those requirements mandate manufacturers to develop and build their products by applying risk management principles and by setting out requirements concerning IT security measures, as well as corresponding conformity assessment procedures. Furthermore, specific guidance on cybersecurity for medical devices is in place since December 2019, providing manufacturers of medical devices, including in vitro diagnostic devices, with guidance on how to fulfil all the relevant essential requirements set out in Annex I to those Regulations with regard to cybersecurity. Products with digital elements to which either of those Regulations apply should not therefore be subject to this Regulation.

Products with digital elements that are developed or modified exclusively for national security or defence purposes or products that are specifically designed to process classified information fall outside the scope of this Regulation. Member States are encouraged to ensure the same or a higher level of protection for those products as for those falling within the scope of this Regulation.

Regulation (EU) 2019/2144 of the European Parliament and of the Council establishes requirements for the type-approval of vehicles, and of their systems and components, introducing certain cybersecurity requirements, including on the operation of a certified cybersecurity management system, on software updates, covering organisations’ policies and processes for cybersecurity risks related to the entire lifecycle of vehicles, equipment and services in compliance with the applicable United Nations regulations on technical specifications and cybersecurity, in particular UN Regulation No 155 – Uniform provisions concerning the approval of vehicles with regards to cybersecurity and cybersecurity management system and providing for specific conformity assessment procedures. In the area of aviation, the principal objective of Regulation (EU) 2018/1139 of the European Parliament and of the Council is to establish and maintain a high uniform level of civil aviation safety in the Union. It creates a framework for essential requirements for airworthiness for aeronautical products, parts and equipment, including software, that includes obligations to protect against information security threats. The certification process under Regulation (EU) 2018/1139 ensures the level of assurance aimed for by this Regulation. Products with digital elements to which Regulation (EU) 2019/2144 applies and products certified in accordance with Regulation (EU) 2018/1139 should not therefore be subject to the essential cybersecurity requirements and conformity assessment procedures set out in this Regulation.

This Regulation lays down horizontal cybersecurity rules which are not specific to sectors or to certain products with digital elements. Nevertheless, sectoral or product-specific Union rules could be introduced, laying down requirements that address all or some of the risks covered by the essential cybersecurity requirements set out in this Regulation. In such cases, the application of this Regulation to products with digital elements covered by other Union rules laying down requirements that address all or some of the risks covered by the essential cybersecurity requirements set out in this Regulation may be limited or excluded where such limitation or exclusion is consistent with the overall regulatory framework applying to those products and where the sectoral rules achieve at least the same level of protection as the one provided for by this Regulation. The Commission should be empowered to adopt delegated acts to supplement this Regulation by identifying such products and rules. For existing Union law where such limitation or exclusion should apply, this Regulation contains specific provisions to clarify its relation with that Union law.

In order to ensure that products with digital elements made available on the market can be repaired effectively and their durability extended, an exemption should be provided for spare parts. That exemption should cover both spare parts that have the purpose of repairing legacy products made available before the date of application of this Regulation and spare parts that have already undergone a conformity assessment procedure pursuant to this Regulation.

Commission Delegated Regulation (EU) 2022/30 specifies that a number of essential requirements set out in Article 3(3), points (d), (e) and (f), of Directive 2014/53/EU of the European Parliament and of the Council , relating to network harm and misuse of network resources, personal data and privacy, and fraud, apply to certain radio equipment. Commission Implementing Decision C(2022) 5637 of 5 August 2022 on a standardisation request to the European Committee for Standardisation and the European Committee for Electrotechnical Standardisation lays down requirements for the development of specific standards further specifying how those essential requirements should be addressed. The essential cybersecurity requirements set out in this Regulation include all the elements of the essential requirements referred to in Article 3(3), points (d), (e) and (f), of Directive 2014/53/EU. Furthermore, the essential cybersecurity requirements set out in this Regulation are aligned with the objectives of the requirements for specific standards included in that standardisation request. Therefore, when the Commission repeals or amends Delegated Regulation (EU) 2022/30 with the consequence that it ceases to apply to certain products subject to this Regulation, the Commission and the European standardisation organisations should take into account the standardisation work carried out in the context of Implementing Decision C(2022) 5637 in the preparation and development of harmonised standards to facilitate the implementation of this Regulation. During the transitional period for the application of this Regulation, the Commission should provide guidance to manufacturers subject to this Regulation that are also subject to Delegated Regulation (EU) 2022/30 to facilitate the demonstration of compliance with the two Regulations.

To the extent that their products fall within the scope of this Regulation, providers of European Digital Identity Wallets as referred to in Article 5a(2) of Regulation (EU) No 910/2014 of the European Parliament and of the Council , should comply with both the horizontal essential cybersecurity requirements set out in this Regulation and the specific security requirements set out in Article 5a of Regulation (EU) No 910/2014. In order to facilitate compliance, wallet providers should be able to demonstrate the compliance of European Digital Identity Wallets with the requirements set out in this Regulation and in Regulation (EU) No 910/2014, respectively, by certifying their products under a European cybersecurity certification scheme established under Regulation (EU) 2019/881 and for which the Commission has specified, by means of delegated acts, a presumption of conformity with this Regulation, in so far as the certificate, or parts thereof, covers those requirements.