CHAPTER I - General Provisions (Art. 1-12) - Digital Horizon by Hannes Snellman

Art. 1 CRA – Subject matter arrow_right_alt

Art. 2 CRA – Scope arrow_right_alt

Applicable: 11 December 2027

This Regulation applies to products with digital elements made available on the market, the intended purpose or reasonably foreseeable use of which includes a direct or indirect logical or physical data connection to a device or network.
This Regulation does not apply to products with digital elements to which the following Union legal acts apply:
1. Regulation (EU) 2017/745;
2. Regulation (EU) 2017/746;
3. Regulation (EU) 2019/2144.
This Regulation does not apply to products with digital elements that have been certified in accordance with Regulation (EU) 2018/1139.
This Regulation does not apply to equipment that falls within the scope of Directive 2014/90/EU of the European Parliament and of the Council (³⁶).
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 Annex I may be limited or excluded where:
1. such limitation or exclusion is consistent with the overall regulatory framework that applies to those products; and
2. the sectoral rules achieve the same or a higher level of protection as that provided for by this Regulation.
The Commission is empowered to adopt delegated acts in accordance with Article 61 to supplement this Regulation by specifying whether such limitation or exclusion is necessary, the products and rules concerned, as well as the scope of the limitation, if relevant.
This Regulation does not apply to spare parts that are made available on the market to replace identical components in products with digital elements and that are manufactured according to the same specifications as the components that they are intended to replace.
This Regulation does not apply to products with digital elements developed or modified exclusively for national security or defence purposes or to products specifically designed to process classified information.
The obligations laid down in this Regulation shall not entail the supply of information the disclosure of which would be contrary to the essential interests of Member States’ national security, public security or defence.

^{(36) Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on marine equipment and repealing Council Directive 96/98/EC (OJ L 257, 28.8.2014, p. 146).}

Art. 3 CRA – Definitions arrow_right_alt

Applicable: 11 December 2027

For the purposes of this Regulation, the following definitions apply:

‘product with digital elements’ means a software or hardware product and its remote data processing solutions, including software or hardware components being placed on the market separately;
‘remote data processing’ means 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;
‘cybersecurity’ means cybersecurity as defined in Article 2, point (1), of Regulation (EU) 2019/881;
‘software’ means the part of an electronic information system which consists of computer code;
‘hardware’ means a physical electronic information system, or parts thereof capable of processing, storing or transmitting digital data;
‘component’ means software or hardware intended for integration into an electronic information system;
‘electronic information system’ means a system, including electrical or electronic equipment, capable of processing, storing or transmitting digital data;
‘logical connection’ means a virtual representation of a data connection implemented through a software interface;
‘physical connection’ means a connection between electronic information systems or components implemented using physical means, including through electrical, optical or mechanical interfaces, wires or radio waves;
‘indirect connection’ means a connection to a device or network, which does not take place directly but rather as part of a larger system that is directly connectable to such device or network;
‘endpoint’ means any device that is connected to a network and serves as an entry point to that network;
‘economic operator’ means the manufacturer, the authorised representative, the importer, the distributor, or other natural or legal person who is subject to obligations in relation to the manufacture of products with digital elements or to the making available of products with digital elements on the market in accordance with this Regulation;
‘manufacturer’ means a 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 its name or trademark, whether for payment, monetisation or free of charge;
‘open-source software steward’ means a legal person, other than a manufacturer, that has the purpose or objective of systematically providing support on a sustained basis for the development of specific products with digital elements, qualifying as free and open-source software and intended for commercial activities, and that ensures the viability of those products;
‘authorised representative’ means a natural or legal person established within the Union who has received a written mandate from a manufacturer to act on its behalf in relation to specified tasks;
‘importer’ means a natural or legal person established in the Union who places on the market a product with digital elements that bears the name or trademark of a natural or legal person established outside the Union;
‘distributor’ means a natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a product with digital elements available on the Union market without affecting its properties;
‘consumer’ means a natural person who acts for purposes which are outside that person’s trade, business, craft or profession;
‘microenterprises’, ‘small enterprises’ and ‘medium-sized enterprises’ mean, respectively, microenterprises, small enterprises and medium-sized enterprises as defined in the Annex to Commission Recommendation 2003/361/EC;
‘support period’ means the period during which a manufacturer is required to ensure that vulnerabilities of a product with digital elements are handled effectively and in accordance with the essential cybersecurity requirements set out in Part II of Annex I;
‘placing on the market’ means the first making available of a product with digital elements on the Union market;
‘making available on the market’ means the supply of a product with digital elements for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;
‘intended purpose’ means the use for which a product with digital elements is intended by the manufacturer, including the specific context and conditions of use, as specified in the information supplied by the manufacturer in the instructions for use, promotional or sales materials and statements, as well as in the technical documentation;
‘reasonably foreseeable use’ means use that is not necessarily the intended purpose supplied by the manufacturer in the instructions for use, promotional or sales materials and statements, as well as in the technical documentation, but which is likely to result from reasonably foreseeable human behaviour or technical operations or interactions;
‘reasonably foreseeable misuse’ means the use of a product with digital elements in a way that is not in accordance with its intended purpose, but which may result from reasonably foreseeable human behaviour or interaction with other systems;
‘notifying authority’ means the national authority responsible for setting up and carrying out the necessary procedures for the assessment, designation and notification of conformity assessment bodies and for their monitoring;
‘conformity assessment’ means the process of verifying whether the essential cybersecurity requirements set out in Annex I have been fulfilled;
‘conformity assessment body’ means a conformity assessment body as defined in Article 2, point (13), of Regulation (EC) No 765/2008;
‘notified body’ means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation;
‘substantial modification’ means a change to the product with digital elements following its placing on the market, which affects the compliance of the product with digital elements with the essential cybersecurity requirements set out in Part I of Annex I or which results in a modification to the intended purpose for which the product with digital elements has been assessed;
‘CE marking’ means a marking by which a manufacturer indicates that a product with digital elements and the processes put in place by the manufacturer are in conformity with the essential cybersecurity requirements set out in Annex I and other applicable Union harmonisation legislation providing for its affixing;
‘Union harmonisation legislation’ means Union legislation listed in Annex I to Regulation (EU) 2019/1020 and any other Union legislation harmonising the conditions for the marketing of products to which that Regulation applies;
‘market surveillance authority’ means a market surveillance authority as defined in Article 3, point (4), of Regulation (EU) 2019/1020;
‘international standard’ means an international standard as defined in Article 2, point (1)(a), of Regulation (EU) No 1025/2012;
‘European standard’ means a European standard as defined in Article 2, point (1)(b), of Regulation (EU) No 1025/2012;
‘harmonised standard’ means a harmonised standard as defined in Article 2, point (1)(c), of Regulation (EU) No 1025/2012;
‘cybersecurity risk’ means the potential for loss or disruption caused by an incident and is to be expressed as a combination of the magnitude of such loss or disruption and the likelihood of occurrence of the incident;
‘significant cybersecurity risk’ means a cybersecurity risk which, based on its technical characteristics, can be assumed to have a high likelihood of an incident that could lead to a severe negative impact, including by causing considerable material or non-material loss or
disruption;
‘software bill of materials’ means a formal record containing details and supply chain relationships of components included in the software elements of a product with digital elements;
‘vulnerability’ means a weakness, susceptibility or flaw of a product with digital elements that can be exploited by a cyber threat;
‘exploitable vulnerability’ means a vulnerability that has the potential to be effectively used by an adversary under practical operational conditions;
‘actively exploited vulnerability’ means a vulnerability for which there is reliable evidence that a malicious actor has exploited it in a system without permission of the system owner;
‘incident’ means an incident as defined in Article 6, point (6), of Directive (EU) 2022/2555;
‘incident having an impact on the security of the product with digital elements’ means an incident that negatively affects or is capable of negatively affecting the ability of a product with digital elements to protect the availability, authenticity, integrity or confidentiality of
data or functions;
‘near miss’ means a near miss as defined in Article 6, point (5), of Directive (EU) 2022/2555;
‘cyber threat’ means a cyber threat as defined in Article 2, point (8), of Regulation (EU) 2019/881;
‘personal data’ means personal data as defined in Article 4, point (1), of Regulation (EU) 2016/679;
‘free and open-source software’ means software the source code of which is openly shared and which is made available under a free and open-source licence which provides for all rights to make it freely accessible, usable, modifiable and redistributable;
‘recall’ means recall as defined in Article 3, point (22), of Regulation (EU) 2019/1020;
‘withdrawal’ means withdrawal as defined in Article 3, point (23), of Regulation (EU) 2019/1020;
‘CSIRT designated as coordinator’ means a CSIRT designated as coordinator pursuant to Article 12(1) of Directive (EU) 2022/2555.

Art. 4 CRA – Free movement arrow_right_alt

Art. 5 CRA – Procurement or use of products with digital elements arrow_right_alt

Art. 6 CRA – Requirements for products with digital elements arrow_right_alt

Art. 7 CRA – Important products with digital elements arrow_right_alt

Applicable: 11 December 2027

Products with digital elements which have the core functionality of a product category set out in Annex III shall be considered to be important products with digital elements and shall be subject to the conformity assessment procedures referred to in Article 32(2) and (3). The integration of a product with digital elements which has the core functionality of a product category set out in Annex III shall not in itself render the product in which it is integrated subject to the conformity assessment procedures referred to in Article 32(2) and (3).
The categories of products with digital elements referred to in paragraph 1 of this Article, divided into classes I and II as set out in Annex III, meet at least one of the following criteria:
1. the product with digital elements primarily performs functions critical to the cybersecurity of other products, networks or services, including securing authentication and access, intrusion prevention and detection, endpoint security or network protection;
2. the product with digital elements performs a function which carries a significant risk of adverse effects in terms of its intensity and ability to disrupt, control or cause damage to a large number of other products or to the health, security or safety of its users through direct manipulation, such as a central system function, including network management, configuration control, virtualisation or processing of personal data.
The Commission is empowered to adopt delegated acts in accordance with Article 61 to amend Annex III by including in the list a new category within each class of the categories of products with digital elements and specifying its definition, moving a category of products from one class to the other or withdrawing an existing category from that list. When assessing the need to amend the list set out in Annex III, the Commission shall take into account the cybersecurity-related functionalities or the function and the level of cybersecurity risk posed by the products with digital elements as set out by the criteria referred to in paragraph 2 of this Article.

The delegated acts referred to in the first subparagraph of this paragraph shall, where appropriate, provide for a minimum transitional period of 12 months, in particular where a new category of important products with digital elements is added to class I or II or is moved from class I to II as set out in Annex III, before the relevant conformity assessment procedures as referred to in Article 32(2) and (3) start applying, unless a shorter
transitional period is justified on imperative grounds of urgency.
By 11 December 2025, the Commission shall adopt an implementing act specifying the technical description of the categories of products with digital elements under classes I and II as set out in Annex III and the technical description of the categories of products with digital elements as set out in Annex IV. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 62(2).

Art. 8 CRA – Critical products with digital elements arrow_right_alt

Applicable: 11 December 2027

The Commission is empowered to adopt delegated acts in accordance with Article 61 to supplement this Regulation to determine which products with digital elements that have the core functionality of a product category that is set out in Annex IV to this Regulation are to be required to obtain a European cybersecurity certificate at assurance level at least ‘substantial’ under a European cybersecurity certification scheme adopted pursuant to Regulation (EU) 2019/881, to demonstrate conformity with the essential cybersecurity requirements set out in Annex I to this Regulation or parts thereof, provided that a European cybersecurity certification scheme covering those categories of products with digital elements has been adopted pursuant to Regulation (EU) 2019/881 and is available to manufacturers. Those delegated acts shall specify the required assurance level that shall be proportionate to the level of cybersecurity risk associated with the products with digital elements and shall take account of their intended purpose, including the critical dependency on them by essential entities as referred to in Article 3(1) of Directive (EU) 2022/2555.

Before adopting such delegated acts, the Commission shall carry out an assessment of the potential market impact of the envisaged measures and shall carry out consultations with relevant stakeholders, including the European Cybersecurity Certification Group established under Regulation (EU) 2019/881. The assessment shall take into account the readiness and the capacity level of the Member States for the implementation of the relevant European cybersecurity certification scheme. Where no delegated acts as referred to in the first subparagraph of this paragraph have been adopted, products with digital elements which have the core functionality of a product category as set out in Annex IV shall be subject to the conformity assessment procedures referred to in Article 32(3).

The delegated acts referred to in the first subparagraph shall provide for a minimum transitional period of six months, unless a shorter transitional period is justified for imperative reasons of urgency.
The Commission is empowered to adopt delegated acts in accordance with Article 61 to amend Annex IV by adding or withdrawing categories of critical products with digital elements. When determining such categories of critical products with digital elements and the required assurance level, in accordance with paragraph 1 of this Article, the Commission shall take into account the criteria referred to in Article 7(2) and ensure that the categories of products with digital elements meet at least one of the following criteria:
1. there is a critical dependency of essential entities as referred to in Article 3 of Directive (EU) 2022/2555 on the category of products with digital elements;
2. incidents and exploited vulnerabilities concerning the category of products with digital elements could lead to serious disruptions of critical supply chains across the internal market.
Before adopting such delegated acts, the Commission shall carry out an assessment of the type referred to in paragraph 1.

The delegated acts referred to in the first subparagraph shall provide for a minimum transitional period of six months, unless a shorter transitional period is justified for imperative reasons of urgency.

Art. 9 CRA – Stakeholder consultation arrow_right_alt

Art. 10 CRA – Enhancing skills in a cyber resilient digital environment arrow_right_alt

Art. 11 CRA – General product safety arrow_right_alt

Applicable: 11 December 2027

By way of derogation from Article 2(1), third subparagraph, point (b), of Regulation (EU) 2023/988, Chapter III, Section 1, Chapters V and VII, and Chapters IX to XI of that Regulation shall apply to products with digital elements with respect to aspects and risks or categories of risks that are not covered by this Regulation where those products are not subject to specific safety requirements laid down in other ‘Union harmonisation legislation’ as defined in Article 3, point (27), of Regulation (EU) 2023/988.

Art. 12 CRA – High-risk AI systems arrow_right_alt

Applicable: 11 December 2027

Without prejudice to the requirements relating to accuracy and robustness set out in Article 15 of Regulation (EU) 2024/1689, products with digital elements which fall within the scope of this Regulation and which are classified as high-risk AI systems pursuant to Article 6 of that Regulation shall be deemed to comply with the cybersecurity requirements set out in Article 15 of that Regulation where:
1. those products fulfil the essential cybersecurity requirements set out in Part I of Annex I;
2. the processes put in place by the manufacturer comply with the essential cybersecurity requirements set out in Part II of Annex I; and
3. the achievement of the level of cybersecurity protection required under Article 15 of Regulation (EU) 2024/1689 is demonstrated in the EU declaration of conformity issued under this Regulation.
For the products with digital elements and cybersecurity requirements referred to in paragraph 1 of this Article, the relevant conformity assessment procedure provided for in Article 43 of Regulation (EU) 2024/1689 shall apply. For the purposes of that assessment, notified bodies which are competent to control the conformity of the high-risk AI systems under Regulation (EU) 2024/1689 shall also be competent to control the conformity of high-risk AI systems which fall within the scope of this Regulation with the requirements set out in Annex I to this Regulation, provided that the compliance of those notified bodies with the requirements laid down in Article 39 of this Regulation has been assessed in the context of the notification procedure under Regulation (EU) 2024/1689.
By way of derogation from paragraph 2 of this Article, important products with digital elements as listed in Annex III to this Regulation, which are subject to the conformity assessment procedures referred to in Article 32(2), points (a) and (b), and Article 32(3) of this Regulation and critical products with digital elements as listed in Annex IV to this Regulation which are required to obtain a European cybersecurity certificate pursuant to Article 8(1) of this Regulation or, absent that, which are subject to the conformity assessment procedures referred to in Article 32(3) of this Regulation, and which are classified as high-risk AI systems pursuant to Article 6 of Regulation (EU) 2024/1689, and to which the conformity assessment procedure based on internal control as referred to in Annex VI to Regulation (EU) 2024/1689 applies, shall be subject to the conformity assessment procedures provided for in this Regulation in so far as the essential cybersecurity requirements set out in this Regulation are concerned.
Manufacturers of products with digital elements referred to in paragraph 1 of this Article may participate in the AI regulatory sandboxes referred to in Article 57 of Regulation (EU) 2024/1689.

Cyber Resilience Act (CRA)