Cyber Resilience Act, Preamble 31 to 40 (15.9.2022)
(31) Regulation [European Health Data Space Regulation proposal] complements the essential requirements laid down in this Regulation. The electronic health record systems (‘EHR systems’) falling under the scope of Regulation [European Health Data Space Regulation proposal] which are products with digital elements within the meaning of this Regulation should therefore also comply with the essential requirements set out in this Regulation. Their manufacturers should demonstrate conformity as required by Regulation [European Health Data Space Regulation proposal]. To facilitate compliance, manufacturers may draw up a single technical documentation containing the elements required by both legal acts. As this Regulation does not cover SaaS as such, EHR systems offered through the SaaS licensing and delivery model are not within the scope of this Regulation. Similarly, EHR systems that are developed and used in-house are not within the scope of this Regulation, as they are not placed on the market.
(32) In order to ensure that products with digital elements are secure both at the time of their placing on the market as well as throughout their life-cycle, it is necessary to lay down essential requirements for vulnerability handling and essential cybersecurity requirements relating to the properties of products with digital elements. While manufacturers should comply with all essential requirements related to vulnerability handling and ensure that all their products are delivered without any known exploitable vulnerabilities, they should determine which other essential requirements related to the product properties are relevant for the concerned type of product. For this purpose, manufacturers should undertake an assessment of the cybersecurity risks associated with a product with digital elements to identify relevant risks and relevant essential requirements and in order to appropriately apply suitable harmonised standards or common specifications.
(33) In order to improve the security of products with digital elements placed on the internal market it is necessary to lay down essential requirements. These essential requirements should be without prejudice to the EU coordinated risk assessments of critical supply chains established by [Article X] of Directive [Directive XXX/XXXX(NIS2)] 28 , which take into account both technical and, where relevant, non-technical risk factors, such as undue influence by a third country on suppliers. Furthermore, it should be without prejudice to the Member States’ prerogatives to lay down additional requirements that take account of non-technical factors for the purpose of ensuring a high level of resilience, including those defined in Recommendation (EU) 2019/534, in the Union-wide coordinated risk assessment of 5G networks security and in the EU Toolbox on 5G cybersecurity agreed by the NIS Cooperation Group as referred to in [Directive XXX/XXXX (NIS2)].
(34) To ensure that the national CSIRTs and the single point of contacts designated in accordance with Article [Article X] of Directive [Directive XX/XXXX (NIS2)] are provided with the information necessary to fulfil their tasks and raise the overall level of cybersecurity of essential and important entities, and to ensure the effective functioning of market surveillance authorities, manufacturers of products with digital elements should notify to ENISA vulnerabilities that are being actively exploited. As most products with digital elements are marketed across the entire internal market, any exploited vulnerability in a product with digital elements should be considered a threat to the functioning of the internal market. Manufacturers should also consider disclosing fixed vulnerabilities to the European vulnerability database established under Directive [Directive XX/XXXX (NIS2)] and managed by ENISA or under any other publicly accessible vulnerability database.
(35) Manufacturers should also report to ENISA any incident having an impact on the security of the product with digital elements. Notwithstanding the incident reporting obligations in Directive [Directive XXX/XXXX (NIS2)] for essential and important entities, it is crucial for ENISA, the single points of contact designated by the Member States in accordance with Article [Article X] of Directive [Directive XXX/XXXX (NIS2)] and the market surveillance authorities to receive information from the manufacturers of products with digital elements allowing them to assess the security of these products. In order to ensure that users can react quickly to incidents having an impact on the security of their products with digital elements, manufacturers should also inform their users about any such incident and, where applicable, about any corrective measures that the users can deploy to mitigate the impact of the incident, for example by publishing relevant information on their websites or, where the manufacturer is able to contact the users and where justified by the risks, by reaching out to the users directly.
(36) Manufacturers of products with digital elements should put in place coordinated vulnerability disclosure policies to facilitate the reporting of vulnerabilities by individuals or entities. A coordinated vulnerability disclosure policy should specify a structured process through which vulnerabilities are reported to a manufacturer in a manner allowing the manufacturer to diagnose and remedy such vulnerabilities before detailed vulnerability information is disclosed to third parties or to the public. Given the fact that information about exploitable vulnerabilities in widely used products with digital elements can be sold at high prices on the black market, manufacturers of such products should be able to use programmes, as part of their coordinated vulnerability disclosure policies, to incentivise the reporting of vulnerabilities by ensuring that individuals or entities receive recognition and compensation for their efforts (so-called ‘bug bounty programmes’).
(37) In order to facilitate vulnerability analysis, manufacturers should identify and document components contained in the products with digital elements, including by drawing up a software bill of materials. A software bill of materials can provide those who manufacture, purchase, and operate software with information that enhances their understanding of the supply chain, which has multiple benefits, most notably it helps manufacturers and users to track known newly emerged vulnerabilities and risks. It is of particular importance for manufacturers to ensure that their products do not contain vulnerable components developed by third parties.
(38) In order to facilitate assessment of conformity with the requirements laid down by this Regulation, there should be a presumption of conformity for products with digital elements which are in conformity with harmonised standards, which translate the essential requirements of this Regulation into detailed technical specifications, and which are adopted in accordance with Regulation (EU) No 1025/2012 of the European Parliament and of the Council 29 . Regulation (EU) No 1025/2012 provides for a procedure for objections to harmonised standards where those standards do not entirely satisfy the requirements of this Regulation.
(39) Regulation (EU) 2019/881 establishes a voluntary European cybersecurity certification framework for ICT products, processes and services. European cybersecurity certification schemes can cover products with digital elements covered by this Regulation. This Regulation should create synergies with Regulation (EU) 2019/881. In order to facilitate the assessment of conformity with the requirements laid down in this Regulation, products with digital elements that are certified or for which a statement of conformity has been issued under a cybersecurity scheme pursuant to Regulation (EU) 2019/881 and which has been identified by the Commission in an implementing act, shall be presumed to be in compliance with the essential requirements of this Regulation in so far as the cybersecurity certificate or statement of conformity or parts thereof cover those requirements. The need for new European cybersecurity certification schemes for products with digital elements should be assessed in the light of this Regulation. Such future European cybersecurity certification schemes covering products with digital elements should take into account the essential requirements as set out in this Regulation and facilitate compliance with this Regulation. The Commission should be empowered to specify, by means of implementing acts, the European cybersecurity certification schemes that can be used to demonstrate conformity with the essential requirements set out in this Regulation. Furthermore, in order to avoid undue administrative burden for manufacturers, where applicable, the Commission should specify if a cybersecurity certificate issued under such European cybersecurity certification schemes eliminates the obligation for manufacturers to carry out a third-party conformity assessment as provided by this Regulation for corresponding requirements.
(40) Upon entry into force of the implementing act setting out the [Commission Implementing Regulation (EU) No …/... of XXX on the European Common Criteria-based cybersecurity certification scheme] (EUCC) which concerns hardware products covered by this Regulation, such as hardware security modules and microprocessors, the Commission may specify, by means of an implementing act, how the EUCC provides a presumption of conformity with the essential requirements as referred to in Annex I of this Regulation or parts thereof. Furthermore, such implementing act may specify how a certificate issued under the EUCC eliminates the obligation for manufacturers to carry out a third-party assessment as requested by this Regulation for corresponding requirements.
Cyber Resilience Act Text 15.9.2022
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