Cyber Resilience Act text, Preamble 21 to 30 (15.9.2022)
(21) In order to ensure that manufacturers can release software for testing purposes before subjecting their products to conformity assessment, Member States should not prevent the making available of unfinished software, such as alpha versions, beta versions or release candidates, as long as the version is only made available for the time necessary to test it and gather feedback. Manufacturers should ensure that software made available under these conditions is only released 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 imposed by this Regulation. Manufacturers should also implement the vulnerability handling requirements to the extent possible. Manufacturers should not force users to upgrade to versions only released for testing purposes.
(22) In order to ensure that products with digital elements, when placed on the market, do not pose cybersecurity risks to persons and organisations, essential requirements should be set out for such products. When the products are subsequently modified, by physical or digital means, in a way that is not foreseen by the manufacturer and that may imply that they no longer meet the relevant essential requirements, the modification should be considered as substantial. For example, software updates or repairs could be assimilated to maintenance operations provided that they do not modify a product already placed on the market in such a way that compliance with the applicable requirements may be affected, or that the intended use for which the product has been assessed may be changed. As is the case for physical repairs or modifications, a product with digital elements should be considered as substantially modified by a software change where the software update modifies the original intended functions, type or performance of the product and these changes were not foreseen in the initial risk assessment, or the nature of the hazard has changed or the level of risk has increased because of the software update.
(23) In line with the commonly established notion of substantial modification for products regulated by Union harmonisation legislation, whenever a substantial modification occurs that may affect the compliance of a product with this Regulation or when the intended purpose of that product changes, it is appropriate that the compliance of the product with digital elements is verified and that, where applicable, it undergoes a new conformity assessment. Where applicable, if the manufacturer undertakes a conformity assessment involving a third party, changes that might lead to substantial modifications should be notified to the third party.
(24) Refurbishing, maintaining and repairing of a product with digital elements, as defined in the Regulation [Eco-design Regulation], does not necessarily lead to a substantial modification of the product, for instance if the intended use and functionalities are not changed and the level of risk remains unaffected. However, upgrading a product by the manufacturer might lead to changes in the design and development of the product and therefore might affect the intended use and the compliance of the product with the requirements set out in this Regulation.
(25) Products with digital elements should be considered critical if the negative impact of the exploitation of potential cybersecurity vulnerabilities in the product can be severe due to, amongst others, the cybersecurity-related functionality, or the intended use. In particular, vulnerabilities in products with digital elements that have a cybersecurity-related functionality, such as secure elements, can lead to a propagation of security issues throughout the supply chain. The severity of the impact of a cybersecurity incident may also increase when taking into account the intended use of the product, such as in an industrial setting or in the context of an essential entity of the type referred to in Annex [Annex I] to Directive [Directive XXX/ XXXX (NIS2)], or for the performance of critical or sensitive functions, such as processing of personal data.
(26) Critical products with digital elements should be subject to stricter conformity assessment procedures, while keeping a proportionate approach. For this purpose, critical products with digital elements should be divided into two classes, reflecting the level of cybersecurity risk linked to these categories of products. A potential cyber incident involving products in class II might lead to greater negative impacts than an incident involving products in class I, for instance due to the nature of their cybersecurity-related function or intended use in sensitive environments, and therefore should undergo a stricter conformity assessment procedure.
(27) The categories of critical products with digital elements referred to in Annex III of this Regulation should be understood as the products which have the core functionality of the type that is listed in Annex III to this Regulation. For example, Annex III to this Regulation lists products which are defined by their core functionality as general purpose microprocessors in class II. As a result, general purpose microprocessors are subject to mandatory third-party conformity assessment. This is not the case for other products not explicitly referred to in Annex III to this Regulation which may integrate a general purpose microprocessor. The Commission should adopt delegated acts [by 12 months since the entry into force of this Regulation] to specify the definitions of the product categories covered under class I and class II as set out in Annex III.
(28) This Regulation addresses cybersecurity risks in a targeted manner. Products with digital elements might, however, pose other safety risks, that are not related to cybersecurity. Those risks should continue to be regulated by other relevant Union product legislation. If no other Union harmonisation legislation is applicable, they should be subject to Regulation [General Product Safety Regulation]. Therefore, in light of the targeted nature of this Regulation, as a derogation from Article 2(1), third subparagraph, point (b), of Regulation [General Product Safety Regulation], Chapter III, Section 1, Chapters V and VII, and Chapters IX to XI of Regulation [General Product Safety Regulation] should apply to products with digital elements with respect to safety risks not covered by this Regulation, if those products are not subject to specific requirements imposed by other Union harmonisation legislation within the meaning of [Article 3, point (25) of the General Product Safety Regulation].
(29) Products with digital elements classified as high-risk AI systems according to Article 6 of Regulation 27 [the AI Regulation] which fall within the scope of this Regulation should comply with the essential requirements set out in this Regulation. When those high-risk AI systems fulfil the essential requirements of this Regulation, they should be deemed compliant with the cybersecurity requirements set out in Article [Article 15] of Regulation [the AI Regulation] in so far as those requirements are covered by the EU declaration of conformity or parts thereof issued under this Regulation. As regards the conformity assessment procedures relating to the essential cybersecurity requirements of a product with digital elements covered by this Regulation and classified as a high-risk AI system, the relevant provisions of Article 43 of Regulation [the AI Regulation] should apply as a rule instead of the respective provisions of this Regulation. However, this rule should not result in reducing the necessary level of assurance for critical products with digital elements covered by this Regulation. Therefore, by way of derogation from this rule, high-risk AI systems that fall within the scope of the Regulation [the AI Regulation] and are also qualified as critical products with digital elements pursuant to this Regulation and to which the conformity assessment procedure based on internal control referred to in Annex VI of the Regulation [the AI Regulation] applies, should be subject to the conformity assessment provisions of this Regulation in so far as the essential requirements of this Regulation are concerned. In this case, for all the other aspects covered by Regulation [the AI Regulation] the respective provisions on conformity assessment based on internal control set out in Annex VI to Regulation [the AI Regulation] should apply.
(30) The machinery products falling within the scope of Regulation [Machinery Regulation proposal] which are products with digital elements within the meaning of this Regulation and for which a declaration of conformity has been issued on the basis of this Regulation should be deemed to be in conformity with the essential health and safety requirements set out in [Annex III, sections 1.1.9 and 1.2.1] of the Regulation [Machinery Regulation proposal], as regards protection against corruption and safety and reliability of control systems in so far as the compliance with those requirements is demonstrated by the EU declaration of conformity issued under this Regulation.
Cyber Resilience Act Text 15.9.2022
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Digital Operational Resilience Act (DORA)