(a) rules for the making available on the market of products with digital elements to ensure the cybersecurity of such products; (b) essential cybersecurity requirements for the design, development and production of products with digital elements, and obligations for economic operators in relation to those products with respect to cybersecurity; (c) essential cybersecurity requirements for the vulnerability handling processes put in place by manufacturers to ensure the cybersecurity of products with digital elements during the time the products are expected to be in use, and obligations for economic operators in relation to those processes; (d) rules on market surveillance, including monitoring, and enforcement of the rules and requirements referred to in this Article.
Regulation (EU) 2024/2847 of the European Parliament and of the Council of 23 October 2024 on horizontal cybersecurity requirements for products with digital elements and amending Regulations (EU) No 168/2013 and (EU) 2019/1020 and Directive (EU) 2020/1828 (Cyber Resilience Act) (Text with EEA relevance)
(a) Regulation (EU) 2017/745; (b) Regulation (EU) 2017/746; (c) Regulation (EU) 2019/2144.
(a) such limitation or exclusion is consistent with the overall regulatory framework that applies to those products; and (b) the sectoral rules achieve the same or a higher level of protection as that provided for by this Regulation.
(1) "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; (2) "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; (3) "cybersecurity" means cybersecurity as defined in Article 2, point (1), of Regulation (EU) 2019/881; (4) "software" means the part of an electronic information system which consists of computer code; (5) "hardware" means a physical electronic information system, or parts thereof capable of processing, storing or transmitting digital data; (6) "component" means software or hardware intended for integration into an electronic information system; (7) "electronic information system" means a system, including electrical or electronic equipment, capable of processing, storing or transmitting digital data; (8) "logical connection" means a virtual representation of a data connection implemented through a software interface; (9) "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; (10) "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; (11) "end-point" means any device that is connected to a network and serves as an entry point to that network; (12) "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; (13) "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; (14) "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; (15) "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; (16) "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; (17) "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; (18) "consumer" means a natural person who acts for purposes which are outside that person’s trade, business, craft or profession; (19) "microenterprises", "small enterprises" and "medium-sized enterprises" mean, respectively, microenterprises, small enterprises and medium-sized enterprises as defined in the Annex to Recommendation 2003/361/EC; (20) "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; (21) "placing on the market" means the first making available of a product with digital elements on the Union market; (22) "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; (23) "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; (24) "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; (25) "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; (26) "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; (27) "conformity assessment" means the process of verifying whether the essential cybersecurity requirements set out in Annex I have been fulfilled; (28) "conformity assessment body" means a conformity assessment body as defined in Article 2, point (13), of Regulation (EC) No 765/2008; (29) "notified body" means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; (30) "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; (31) "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; (32) "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; (33) "market surveillance authority" means a market surveillance authority as defined in Article 3, point (4), of Regulation (EU) 2019/1020; (34) "international standard" means an international standard as defined in Article 2, point (1)(a), of Regulation (EU) No 1025/2012; (35) "European standard" means a European standard as defined in Article 2, point (1)(b), of Regulation (EU) No 1025/2012; (36) "harmonised standard" means a harmonised standard as defined in Article 2, point (1)(c), of Regulation (EU) No 1025/2012; (37) "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; (38) "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; (39) "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; (40) "vulnerability" means a weakness, susceptibility or flaw of a product with digital elements that can be exploited by a cyber threat; (41) "exploitable vulnerability" means a vulnerability that has the potential to be effectively used by an adversary under practical operational conditions; (42) "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; (43) "incident" means an incident as defined in Article 6, point (6), of Directive (EU) 2022/2555; (44) "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; (45) "near miss" means a near miss as defined in Article 6, point (5), of Directive (EU) 2022/2555; (46) "cyber threat" means a cyber threat as defined in Article 2, point (8), of Regulation (EU) 2019/881; (47) "personal data" means personal data as defined in Article 4, point (1), of Regulation (EU) 2016/679; (48) "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; (49) "recall" means recall as defined in Article 3, point (22), of Regulation (EU) 2019/1020; (50) "withdrawal" means withdrawal as defined in Article 3, point (23), of Regulation (EU) 2019/1020; (51) "CSIRT designated as coordinator" means a CSIRT designated as coordinator pursuant to Article 12(1) of Directive (EU) 2022/2555.
(a) they meet the essential cybersecurity requirements set out in Part I of Annex I, provided that they are properly installed, maintained, used for their intended purpose or under conditions which can reasonably be foreseen, and, where applicable, the necessary security updates have been installed; and (b) the processes put in place by the manufacturer comply with the essential cybersecurity requirements set out in Part II of Annex I.
(a) 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, end-point security or network protection; (b) 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.
(a) 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; (b) 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.
(a) preparing the guidance referred to in Article 26; (b) preparing the technical descriptions of the product categories set out in Annex III in accordance with Article 7(4), assessing the need for potential updates of the list of product categories in accordance with Article 7(3) and Article 8(2), or carrying out the assessment of the potential market impact referred to in Article 8(1), without prejudice to Article 61; (c) undertaking preparatory work for the evaluation and review of this Regulation.
(a) develop cybersecurity skills and create organisational and technological tools to ensure sufficient availability of skilled professionals in order to support the activities of the market surveillance authorities and conformity assessment bodies; (b) increase collaboration between the private sector, economic operators, including via re-skilling or up-skilling for manufacturers’ employees, consumers, training providers as well as public administrations, thereby expanding the options for young people to access jobs in the cybersecurity sector.
(a) those products fulfil the essential cybersecurity requirements set out in Part I of Annex I; (b) the processes put in place by the manufacturer comply with the essential cybersecurity requirements set out in Part II of Annex I; and (c) 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.
(a) an early warning notification of an actively exploited vulnerability, without undue delay and in any event within 24 hours of the manufacturer becoming aware of it, indicating, where applicable, the Member States on the territory of which the manufacturer is aware that their product with digital elements has been made available; (b) unless the relevant information has already been provided, a vulnerability notification, without undue delay and in any event within 72 hours of the manufacturer becoming aware of the actively exploited vulnerability, which shall provide general information, as available, about the product with digital elements concerned, the general nature of the exploit and of the vulnerability concerned as well as any corrective or mitigating measures taken, and corrective or mitigating measures that users can take, and which shall also indicate, where applicable, how sensitive the manufacturer considers the notified information to be; (c) unless the relevant information has already been provided, a final report, no later than 14 days after a corrective or mitigating measure is available, including at least the following: (i) a description of the vulnerability, including its severity and impact; (ii) where available, information concerning any malicious actor that has exploited or that is exploiting the vulnerability; (iii) details about the security update or other corrective measures that have been made available to remedy the vulnerability.
(a) an early warning notification of a severe incident having an impact on the security of the product with digital elements, without undue delay and in any event within 24 hours of the manufacturer becoming aware of it, including at least whether the incident is suspected of being caused by unlawful or malicious acts, which shall also indicate, where applicable, the Member States on the territory of which the manufacturer is aware that their product with digital elements has been made available; (b) unless the relevant information has already been provided, an incident notification, without undue delay and in any event within 72 hours of the manufacturer becoming aware of the incident, which shall provide general information, where available, about the nature of the incident, an initial assessment of the incident, as well as any corrective or mitigating measures taken, and corrective or mitigating measures that users can take, and which shall also indicate, where applicable, how sensitive the manufacturer considers the notified information to be; (c) unless the relevant information has already been provided, a final report, within one month after the submission of the incident notification under point (b), including at least the following: (i) a detailed description of the incident, including its severity and impact; (ii) the type of threat or root cause that is likely to have triggered the incident; (iii) applied and ongoing mitigation measures.
(a) it 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 sensitive or important data or functions; or (b) it has led or is capable of leading to the introduction or execution of malicious code in a product with digital elements or in the network and information systems of a user of the product with digital elements.
(a) the Member State in which the authorised representative acting on behalf of the manufacturer for the highest number of products with digital elements of that manufacturer is established; (b) the Member State in which the importer placing on the market the highest number of products with digital elements of that manufacturer is established; (c) the Member State in which the distributor making available on the market the highest number of products with digital elements of that manufacturer is established; (d) the Member State in which the highest number of users of products with digital elements of that manufacturer are located.
(a) that the notified vulnerability has been actively exploited by a malicious actor and, according to the information available, it has been exploited in no other Member State than the one of the CSIRT designated as coordinator to which the manufacturer has notified the vulnerability; (b) that any immediate further dissemination of the notified vulnerability would likely result in the supply of information the disclosure of which would be contrary to the essential interests of that Member State; or (c) that the notified vulnerability poses an imminent high cybersecurity risk stemming from the further dissemination;
(a) keep the EU declaration of conformity referred to in Article 28 and the technical documentation referred to in Article 31 at the disposal of the market surveillance authorities for at least 10 years after the product with digital elements has been placed on the market or for the support period, whichever is longer; (b) further to a reasoned request from a market surveillance authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of the product with digital elements; (c) cooperate with the market surveillance authorities, at their request, on any action taken to eliminate the risks posed by a product with digital elements covered by the authorised representative’s mandate.
(a) the appropriate conformity assessment procedures as referred to in Article 32 have been carried out by the manufacturer; (b) the manufacturer has drawn up the technical documentation; (c) the product with digital elements bears the CE marking referred to in Article 30 and is accompanied by the EU declaration of conformity referred to in Article 13(20) and the information and instructions to the user as set out in Annex II in a language which can be easily understood by users and market surveillance authorities; (d) the manufacturer has complied with the requirements set out in Article 13(15), (16) and (19).
(a) the product with digital elements bears the CE marking; (b) the manufacturer and the importer have complied with the obligations set out in Article 13(15), (16), (18), (19) and (20) and Article 19(4), and have provided all necessary documents to the distributor.
(a) the name and address of any economic operator who has supplied them with a product with digital elements; (b) where available, the name and address of any economic operator to whom they have supplied a product with digital elements.
(a) the scope of this Regulation, with a particular focus on remote data processing solutions and free and open-source software; (b) the application of support periods in relation to particular categories of products with digital elements; (c) guidance targeted at manufacturers subject to this Regulation that are also subject to Union harmonisation legislation other than this Regulation or to other related Union legal acts; (d) the concept of substantial modification.
(a) the Commission has requested, pursuant to Article 10(1) of Regulation (EU) No 1025/2012, one or more European standardisation organisations to draft a harmonised standard for the essential cybersecurity requirements set out in Annex I and: (i) the request has not been accepted; (ii) the harmonised standards addressing that request are not delivered within the deadline set in accordance with Article 10(1) of Regulation (EU) No 1025/2012; or (iii) the harmonised standards do not comply with the request; and
(b) no reference to harmonised standards covering the relevant essential cybersecurity requirements set out in Annex I to this Regulation has been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and no such reference is expected to be published within a reasonable period.
(a) the internal control procedure (based on module A) set out in Annex VIII; (b) the EU-type examination procedure (based on module B) set out in Annex VIII followed by conformity to EU-type based on internal production control (based on module C) set out in Annex VIII; (c) a conformity assessment based on full quality assurance (based on module H) set out in Annex VIII; or (d) where available and applicable, a European cybersecurity certification scheme pursuant to Article 27(9).
(a) the EU-type examination procedure (based on module B) set out in Annex VIII followed by conformity to EU-type based on internal production control (based on module C) set out in Annex VIII; or (b) a conformity assessment based on full quality assurance (based on module H) set out in Annex VIII.
(a) EU-type examination procedure (based on module B) set out in Annex VIII followed by conformity to EU-type based on internal production control (based on module C) set out in Annex VIII; (b) a conformity assessment based on full quality assurance (based on module H) set out in Annex VIII; or (c) where available and applicable, a European cybersecurity certification scheme pursuant to Article 27(9) of this Regulation at assurance level at least "substantial" pursuant to Regulation (EU) 2019/881.
(a) a European cybersecurity certification scheme in accordance with Article 8(1); or (b) where the conditions in Article 8(1) are not met, any of the procedures referred to in paragraph 3 of this Article.
(a) organise specific awareness-raising and training activities about the application of this Regulation; (b) establish a dedicated channel for communication with microenterprises and small enterprises and, as appropriate, local public authorities to provide advice and respond to queries about the implementation of this Regulation; (c) support testing and conformity assessment activities, including where relevant with the support of the European Cybersecurity Competence Centre.
(a) personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks; (b) descriptions of procedures in accordance with which conformity assessment is to be carried out, ensuring the transparency of and ability to reproduce those procedures. It shall have appropriate policies and procedures in place that distinguish between tasks it carries out as a notified body and other activities; (c) procedures for the performance of activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the production process.
(a) sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been notified; (b) satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments; (c) appropriate knowledge and understanding of the essential cybersecurity requirements set out in Annex I, of the applicable harmonised standards and common specifications, and of the relevant provisions of Union harmonisation legislation and implementing acts; (d) the ability to draw up certificates, records and reports demonstrating that assessments have been carried out.
(a) any refusal, restriction, suspension or withdrawal of a certificate; (b) any circumstances affecting the scope of and conditions for notification; (c) any request for information which they have received from market surveillance authorities regarding conformity assessment activities; (d) on request, conformity assessment activities performed within the scope of their notification and any other activity performed, including cross-border activities and subcontracting.
(a) a failure of the product with digital elements or of the processes put in place by the manufacturer to meet the essential cybersecurity requirements set out in Annex I; (b) shortcomings in the harmonised standards, European cybersecurity certification schemes or common specifications, as referred to in Article 27.
(a) the health or safety of persons; (b) the compliance with obligations under Union or national law intended to protect fundamental rights; (c) the availability, authenticity, integrity or confidentiality of services offered using an electronic information system by essential entities as referred to in Article 3(1) of Directive (EU) 2022/2555; or (d) other aspects of public interest protection.
(a) the CE marking has been affixed in violation of Articles 29 and 30; (b) the CE marking has not been affixed; (c) the EU declaration of conformity has not been drawn up; (d) the EU declaration of conformity has not been drawn up correctly; (e) the identification number of the notified body which is involved in the conformity assessment procedure, where applicable, has not been affixed; (f) the technical documentation is either not available or not complete.
(a) intellectual property rights and confidential business information or trade secrets of a natural or legal person, including source code, except the cases referred to in Article 5 of Directive (EU) 2016/943 of the European Parliament and of the Council Directive (EU) 2016/943 of the European Parliament and of the Council of 8 June 2016 on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure (OJ L 157, 15.6.2016, p. 1 ).(b) the effective implementation of this Regulation, in particular for the purposes of inspections, investigations or audits; (c) public and national security interests; (d) integrity of criminal or administrative proceedings.
(a) the nature, gravity and duration of the infringement and of its consequences; (b) whether administrative fines have been already applied by the same or other market surveillance authorities to the same economic operator for a similar infringement; (c) the size, in particular with regard to microenterprises and small and medium sized-enterprises, including start-ups, and the market share of the economic operator committing the infringement.
(a) manufacturers that qualify as microenterprises or small enterprises with regard to any failure to meet the deadline referred to in Article 14(2), point (a), or Article 14(4), point (a); (b) any infringement of this Regulation by open-source software stewards.
"72. Regulation (EU) 2024/2847 of the European Parliament and of the Council Regulation (EU) 2024/2847 of the European Parliament and of the Council of 23 October 2024 on horizontal cybersecurity requirements for products with digital elements and amending Regulations (EU) No 168/2013 and (EU) No 2019/1020 and Directive (EU) 2020/1828 (Cyber Resilience Act) (OJ L, 2024/2847, 20.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2847/oj ).".
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"69. Regulation (EU) 2024/2847 of the European Parliament and of the Council Regulation (EU) 2024/2847 of the European Parliament and of the Council of 23 October 2024 on horizontal cybersecurity requirements for products with digital elements and amending Regulations (EU) No 168/2013 and (EU) No 2019/1020 and Directive (EU) 2020/1828 (Cyber Resilience Act) (OJ L, 2024/2847, 20.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2847/oj ).".
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| 16 | 18 | protection of vehicle against cyberattacks | x | x | x | x | x | x | x | x | x | x | x | x | x | x |
(a) be made available on the market without known exploitable vulnerabilities; (b) be made available on the market with a secure by default configuration, unless otherwise agreed between manufacturer and business user in relation to a tailor-made product with digital elements, including the possibility to reset the product to its original state; (c) ensure that vulnerabilities can be addressed through security updates, including, where applicable, through automatic security updates that are installed within an appropriate timeframe enabled as a default setting, with a clear and easy-to-use opt-out mechanism, through the notification of available updates to users, and the option to temporarily postpone them; (d) ensure protection from unauthorised access by appropriate control mechanisms, including but not limited to authentication, identity or access management systems, and report on possible unauthorised access; (e) protect the confidentiality of stored, transmitted or otherwise processed data, personal or other, such as by encrypting relevant data at rest or in transit by state of the art mechanisms, and by using other technical means; (f) protect the integrity of stored, transmitted or otherwise processed data, personal or other, commands, programs and configuration against any manipulation or modification not authorised by the user, and report on corruptions; (g) process only data, personal or other, that are adequate, relevant and limited to what is necessary in relation to the intended purpose of the product with digital elements (data minimisation); (h) protect the availability of essential and basic functions, also after an incident, including through resilience and mitigation measures against denial-of-service attacks; (i) minimise the negative impact by the products themselves or connected devices on the availability of services provided by other devices or networks; (j) be designed, developed and produced to limit attack surfaces, including external interfaces; (k) be designed, developed and produced to reduce the impact of an incident using appropriate exploitation mitigation mechanisms and techniques; (l) provide security related information by recording and monitoring relevant internal activity, including the access to or modification of data, services or functions, with an opt-out mechanism for the user; (m) provide the possibility for users to securely and easily remove on a permanent basis all data and settings and, where such data can be transferred to other products or systems, ensure that this is done in a secure manner.
(1) identify and document vulnerabilities and components contained in products with digital elements, including by drawing up a software bill of materials in a commonly used and machine-readable format covering at the very least the top-level dependencies of the products; (2) in relation to the risks posed to products with digital elements, address and remediate vulnerabilities without delay, including by providing security updates; where technically feasible, new security updates shall be provided separately from functionality updates; (3) apply effective and regular tests and reviews of the security of the product with digital elements; (4) once a security update has been made available, share and publicly disclose information about fixed vulnerabilities, including a description of the vulnerabilities, information allowing users to identify the product with digital elements affected, the impacts of the vulnerabilities, their severity and clear and accessible information helping users to remediate the vulnerabilities; in duly justified cases, where manufacturers consider the security risks of publication to outweigh the security benefits, they may delay making public information regarding a fixed vulnerability until after users have been given the possibility to apply the relevant patch; (5) put in place and enforce a policy on coordinated vulnerability disclosure; (6) take measures to facilitate the sharing of information about potential vulnerabilities in their product with digital elements as well as in third-party components contained in that product, including by providing a contact address for the reporting of the vulnerabilities discovered in the product with digital elements; (7) provide for mechanisms to securely distribute updates for products with digital elements to ensure that vulnerabilities are fixed or mitigated in a timely manner and, where applicable for security updates, in an automatic manner; (8) ensure that, where security updates are available to address identified security issues, they are disseminated without delay and, unless otherwise agreed between a manufacturer and a business user in relation to a tailor-made product with digital elements, free of charge, accompanied by advisory messages providing users with the relevant information, including on potential action to be taken.
1. the name, registered trade name or registered trademark of the manufacturer, and the postal address, the email address or other digital contact as well as, where available, the website at which the manufacturer can be contacted; 2. the single point of contact where information about vulnerabilities of the product with digital elements can be reported and received, and where the manufacturer’s policy on coordinated vulnerability disclosure can be found; 3. name and type and any additional information enabling the unique identification of the product with digital elements; 4. the intended purpose of the product with digital elements, including the security environment provided by the manufacturer, as well as the product’s essential functionalities and information about the security properties; 5. any known or foreseeable circumstance, related to the use of the product with digital elements in accordance with its intended purpose or under conditions of reasonably foreseeable misuse, which may lead to significant cybersecurity risks; 6. where applicable, the internet address at which the EU declaration of conformity can be accessed; 7. the type of technical security support offered by the manufacturer and the end-date of the support period during which users can expect vulnerabilities to be handled and to receive security updates; 8. detailed instructions or an internet address referring to such detailed instructions and information on: (a) the necessary measures during initial commissioning and throughout the lifetime of the product with digital elements to ensure its secure use; (b) how changes to the product with digital elements can affect the security of data; (c) how security-relevant updates can be installed; (d) the secure decommissioning of the product with digital elements, including information on how user data can be securely removed; (e) how the default setting enabling the automatic installation of security updates, as required by Part I, point (2)(c), of Annex I, can be turned off; (f) where the product with digital elements is intended for integration into other products with digital elements, the information necessary for the integrator to comply with the essential cybersecurity requirements set out in Annex I and the documentation requirements set out in Annex VII.
9. If the manufacturer decides to make available the software bill of materials to the user, information on where the software bill of materials can be accessed.
1. Name and type and any additional information enabling the unique identification of the product with digital elements 2. Name and address of the manufacturer or its authorised representative 3. A statement that the EU declaration of conformity is issued under the sole responsibility of the provider 4. Object of the declaration (identification of the product with digital elements allowing traceability, which may include a photograph, where appropriate) 5. A statement that the object of the declaration described above is in conformity with the relevant Union harmonisation legislation 6. References to any relevant harmonised standards used or any other common specification or cybersecurity certification in relation to which conformity is declared 7. Where applicable, the name and number of the notified body, a description of the conformity assessment procedure performed and identification of the certificate issued 8. Additional information: Signed for and on behalf of: (place and date of issue): (name, function) (signature):
Hereby, … [name of manufacturer] declares that the product with digital elements type … [designation of type of product with digital element] is in compliance with Regulation (EU) 2024/2847 OJ L, 2024/2847, 20.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2847/oj .The full text of the EU declaration of conformity is available at the following internet address: …
1. a general description of the product with digital elements, including: (a) its intended purpose; (b) versions of software affecting compliance with essential cybersecurity requirements; (c) where the product with digital elements is a hardware product, photographs or illustrations showing external features, marking and internal layout; (d) user information and instructions as set out in Annex II;
2. a description of the design, development and production of the product with digital elements and vulnerability handling processes, including: (a) necessary information on the design and development of the product with digital elements, including, where applicable, drawings and schemes and a description of the system architecture explaining how software components build on or feed into each other and integrate into the overall processing; (b) necessary information and specifications of the vulnerability handling processes put in place by the manufacturer, including the software bill of materials, the coordinated vulnerability disclosure policy, evidence of the provision of a contact address for the reporting of the vulnerabilities and a description of the technical solutions chosen for the secure distribution of updates; (c) necessary information and specifications of the production and monitoring processes of the product with digital elements and the validation of those processes;
3. an assessment of the cybersecurity risks against which the product with digital elements is designed, developed, produced, delivered and maintained pursuant to Article 13, including how the essential cybersecurity requirements set out in Part I of Annex I are applicable; 4. relevant information that was taken into account to determine the support period pursuant to Article 13(8) of the product with digital elements; 5. a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union , common specifications as set out in Article 27 of this Regulation or European cybersecurity certification schemes adopted pursuant to Regulation (EU) 2019/881 pursuant to Article 27(8) of this Regulation, and, where those harmonised standards, common specifications or European cybersecurity certification schemes have not been applied, descriptions of the solutions adopted to meet the essential cybersecurity requirements set out in Parts I and II of Annex I, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards, common specifications or European cybersecurity certification schemes, the technical documentation shall specify the parts which have been applied;6. reports of the tests carried out to verify the conformity of the product with digital elements and of the vulnerability handling processes with the applicable essential cybersecurity requirements as set out in Parts I and II of Annex I; 7. a copy of the EU declaration of conformity; 8. where applicable, the software bill of materials, further to a reasoned request from a market surveillance authority provided that it is necessary in order for that authority to be able to check compliance with the essential cybersecurity requirements set out in Annex I.
3.1. the name and address of the manufacturer and, if the application is lodged by the authorised representative, the name and address of that authorised representative; 3.2. a written declaration that the same application has not been lodged with any other notified body; 3.3. the technical documentation, which shall make it possible to assess the conformity of the product with digital elements with the applicable essential cybersecurity requirements as set out in Part I of Annex I and the manufacturer’s vulnerability handling processes set out in Part II of Annex I and shall include an adequate analysis and assessment of the risks. The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the product with digital elements. The technical documentation shall contain, wherever applicable, at least the elements set out in Annex VII; 3.4. the supporting evidence for the adequacy of the technical design and development solutions and vulnerability handling processes. This supporting evidence shall mention any documents that have been used, in particular where the relevant harmonised standards or technical specifications have not been applied in full. The supporting evidence shall include, where necessary, the results of tests carried out by the appropriate laboratory of the manufacturer, or by another testing laboratory on its behalf and under its responsibility.
4.1. examine the technical documentation and supporting evidence to assess the adequacy of the technical design and development of the product with digital elements with the essential cybersecurity requirements set out in Part I of Annex I and of the vulnerability handling processes put in place by the manufacturer with the essential cybersecurity requirements set out in Part II of Annex I; 4.2. verify that specimens have been developed or manufactured in conformity with the technical documentation, and identify the elements which have been designed and developed in accordance with the applicable provisions of the relevant harmonised standards or technical specifications, as well as the elements which have been designed and developed without applying the relevant provisions of those standards; 4.3. carry out appropriate examinations and tests, or have them carried out, to check that, where the manufacturer has chosen to apply the solutions in the relevant harmonised standards or technical specifications for the requirements set out in Annex I, they have been applied correctly; 4.4. carry out appropriate examinations and tests, or have them carried out, to check that, where the solutions in the relevant harmonised standards or technical specifications for the requirements set out in Annex I have not been applied, the solutions adopted by the manufacturer meet the corresponding essential cybersecurity requirements; 4.5. agree with the manufacturer on a location where the examinations and tests will be carried out.
3.1. The manufacturer shall affix the CE marking to each individual product with digital elements that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements set out in this Regulation. 3.2. The manufacturer shall draw up a written declaration of conformity for a product model and keep it at the disposal of the national authorities for 10 years after the product with digital elements has been placed on the market or for the support period, whichever is longer. The declaration of conformity shall identify the product model for which it has been drawn up. A copy of the declaration of conformity shall be made available to the relevant authorities upon request.
3.1. The manufacturer shall lodge an application for assessment of its quality system with the notified body of its choice, for the products with digital elements concerned. The application shall include: (a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, the name and address of that authorised representative; (b) the technical documentation for one model of each category of products with digital elements intended to be manufactured or developed. The technical documentation shall, wherever applicable, contain at least the elements as set out in Annex VII; (c) the documentation concerning the quality system; and (d) a written declaration that the same application has not been lodged with any other notified body.
3.2. The quality system shall ensure compliance of the products with digital elements with the essential cybersecurity requirements set out in Part I of Annex I and compliance of the vulnerability handling processes put in place by the manufacturer with the requirements set out in Part II of Annex I. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. That quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall, in particular, contain an adequate description of: (a) the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design, development, product quality and vulnerability handling; (b) the technical design and development specifications, including standards, that will be applied and, where the relevant harmonised standards or technical specifications will not be applied in full, the means that will be used to ensure that the essential cybersecurity requirements set out in Part I of Annex I that apply to the products with digital elements will be met; (c) the procedural specifications, including standards, that will be applied and, where the relevant harmonised standards or technical specifications will not be applied in full, the means that will be used to ensure that the essential cybersecurity requirements set out in Part II of Annex I that apply to the manufacturer will be met; (d) the design and development control, as well as design and development verification techniques, processes and systematic actions that will be used when designing and developing the products with digital elements pertaining to the product category covered; (e) the corresponding production, quality control and quality assurance techniques, processes and systematic actions that will be used; (f) the examinations and tests that will be carried out before, during and after production, and the frequency with which they will be carried out; (g) the quality records, such as inspection reports and test data, calibration data and qualification reports on the personnel concerned; (h) the means of monitoring the achievement of the required design and product quality and the effective operation of the quality system.
3.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the national standard that implements the relevant harmonised standard or technical specification. In addition to experience in quality management systems, the auditing team shall have at least one member experienced as an assessor in the relevant product field and product technology concerned, and shall have knowledge of the applicable requirements set out in this Regulation. The audit shall include an assessment visit to the manufacturer’s premises, where such premises exist. The auditing team shall review the technical documentation referred to in point 3.1 (b), to verify the manufacturer’s ability to identify the applicable requirements set out in this Regulation and to carry out the necessary examinations with a view to ensuring compliance of the product with digital elements with those requirements. The manufacturer or its authorised representative shall be notified of the decision. The notification shall contain the conclusions of the audit and the reasoned assessment decision. 3.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient. 3.5. The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system. The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary. It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.
4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. 4.2. The manufacturer shall, for assessment purposes, allow the notified body access to the design, development, production, inspection, testing and storage sites, and shall provide it with all necessary information, in particular: (a) the quality system documentation; (b) the quality records as provided for by the design part of the quality system, such as results of analyses, calculations and tests; (c) the quality records as provided for by the manufacturing part of the quality system, such as inspection reports and test data, calibration data and qualification reports on the personnel concerned.
4.3. The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report.
5.1. The manufacturer shall affix the CE marking, and, under the responsibility of the notified body referred to in point 3.1, the latter’s identification number to each individual product with digital elements that satisfies the requirements set out in Part I of Annex I. 5.2. The manufacturer shall draw up a written declaration of conformity for each product model and keep it at the disposal of the national authorities for 10 years after the product with digital elements has been placed on the market or for the support period, whichever is longer. The declaration of conformity shall identify the product model for which it has been drawn up. A copy of the declaration of conformity shall be made available to the relevant authorities upon request.
(a) the technical documentation referred to in point 3.1; (b) the documentation concerning the quality system referred to in point 3.1; (c) the change referred to in point 3.5, as approved; (d) the decisions and reports of the notified body referred to in points 3.5 and 4.3.