Fabriquants d'objets connectés

Dans un monde de plus en plus connecté, les cyber-attaques présentent des risques importants pour les fabricants d'objets connectés.

En s'engageant proactivement dans la Loi sur la cyber-résilience et en adoptant les mesures requises, les fabricants peuvent naviguer plus efficacement dans le monde complexe de la cyber)sécurité. Cela leur permet de protéger leurs produits de manière plus efficace tout en contribuant à créer un écosystème plus sûr et plus résilient, bénéficiant ainsi à l'ensemble de la chaîne d'approvisionnement.

Découvrez notre guide pour les fabriquants d'objets connectés !

Prérequis

Avant de mettre sur le marché un produit contenant des éléments numériques, les fabriquants doivent s'assurer que

  • Analyze potential risks based on intended use, foreseeable conditions, and expected lifespan.
  • Integrate components securely: Exercise due diligence when sourcing components from third parties, including open-source software, to ensure they don’t compromise the product’s cybersecurity.
  • Have policies and procedures to address vulnerabilities reported from internal or external sources, including coordinated disclosure policies.
  • Prepare technical documentation.
  • Choose and conduct conformity assessment procedures.
  • Issue an EU declaration of conformity and affix the CE marking.
  • Include identification markings (type, batch, serial number) on the product, packaging, or accompanying documents.
  • Indicate the manufacturer’s name, contact details, and website on the product, packaging, or accompanying documents.
  • Provide support for at least 5 years, or the product’s lifespan if shorter.
  • Ensure security updates released during the support period remain available for at least 10 years or the remaining support period, whichever is longer.

Base juridique

For the purpose of complying with paragraph 1, manufacturers shall undertake an assessment of the cybersecurity risks associated with a product with digital elements and take the outcome of that assessment into account during the planning, design, development, production, delivery and maintenance phases of the product with digital elements with a view to minimising cybersecurity risks, preventing incidents and minimising their impact, including in relation to the health and safety of users.

For the purpose of complying with paragraph 1, manufacturers shall exercise due diligence when integrating components sourced from third parties so that those components do not compromise the cybersecurity of the product with digital elements, including when integrating components of free and open-source software that have not been made available on the market in the course of a commercial activity.

Manufacturers shall ensure, when placing a product with digital elements on the market, and for the support period, that vulnerabilities of that product, including its components, are handled effectively and in accordance with the essential cybersecurity requirements set out in Part II of Annex I. Manufacturers shall determine the support period so that it reflects the length of time during which the product is expected to be in use, taking into account, in particular, reasonable user expectations, the nature of the product, including its intended purpose, as well as relevant Union law determining the lifetime of products with digital elements.

When determining the support period, manufacturers may also take into account the support periods of products with digital elements offering a similar functionality placed on the market by other manufacturers, the availability of the operating environment, the support periods of integrated components that provide core functions and are sourced from third parties as well as relevant guidance provided by the dedicated administrative cooperation group (ADCO) established pursuant to Article 52(15) and the Commission. The matters to be taken into account in order to determine the support period shall be considered in a manner that ensures proportionality.

Sans préjudice du deuxième alinéa, la période d'assistance est d'au moins cinq ans. Lorsqu'il est prévu que le produit contenant des éléments numériques sera utilisé pendant moins de cinq ans, la période d'assistance correspond à la durée d'utilisation prévue. 

Taking into account ADCO recommendations as referred to in Article 52(16), the Commission may adopt delegated acts in accordance with Article 61 to supplement this Regulation by specifying the minimum support period for specific product categories where the market surveillance data suggests inadequate support periods.

Manufacturers shall include the information that was taken into account to determine the support period of a product with digital elements in the technical documentation as set out in Annex VII.

Manufacturers shall have appropriate policies and procedures, including coordinated vulnerability disclosure policies, referred to in Part II, point (5), of Annex I to process and remediate potential vulnerabilities in the product with digital elements reported from internal or external sources.

Before placing a product with digital elements on the market, manufacturers shall draw up the technical documentation referred to in Article 31.

They shall carry out the chosen conformity assessment procedures as referred to in Article 32 or have them carried out.

Where compliance of the product with digital elements with the essential cybersecurity requirements set out in Part I of Annex I and of the processes put in place by the manufacturer with the essential cybersecurity requirements set out in Part II of Annex I has been demonstrated by that conformity assessment procedure, manufacturers shall draw up the EU declaration of conformity in accordance with Article 28 and affix the CE marking in accordance with Article 30.

Manufacturers shall ensure that their products with digital elements bear a type, batch or serial number or other element allowing their identification, or, where that is not possible, that that information is provided on their packaging or in a document accompanying the product with digital elements.

Manufacturers shall indicate the name, registered trade name or registered trademark of the manufacturer, and the postal address, email address or other digital contact details, as well as, where applicable, the website where the manufacturer can be contacted, on the product with digital elements, on its packaging or in a document accompanying the product with digital elements. That information shall also be included in the information and instructions to the user set out in Annex II. The contact details shall be in a language which can be easily understood by users and market surveillance authorities.

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Documentation

The following mandatory documentation requirements must be fulfilled by manufacturers:

    • Technical Documentation: This includes relevant cybersecurity aspects like identified vulnerabilities, third-party information, and updates to the risk assessment. It must be kept for 10 years or the support period (whichever is longer) after the product hits the market.
    • EU Declaration of Conformity: This document proves compliance with essential requirements. Manufacturers can provide either the full version or a simplified version with a link to the full one online. Both versions must be kept available for 10 years or the support period.
    • User Information and Instructions: These guides on safe installation, operation, and use must be clear, understandable, and in a language users and authorities can readily grasp. They must be kept accessible for 10 years or the support period, online or physically.

Base juridique

When placing a product with digital elements on the market, the manufacturer shall include the cybersecurity risk assessment referred to in paragraph 3 of this Article in the technical documentation required pursuant to Article 31 and Annex VII. For products with digital elements as referred to in Article 12, which are also subject to other Union legal acts, the cybersecurity risk assessment may be part of the risk assessment required by those Union legal acts. Where certain essential cybersecurity requirements are not applicable to the product with digital elements, the manufacturer shall include a clear justification to that effect in that technical documentation.

The manufacturers shall systematically document, in a manner that is proportionate to the nature and the cybersecurity risks, relevant cybersecurity aspects concerning the products with digital elements, including vulnerabilities of which they become aware and any relevant information provided by third parties, and shall, where applicable, update the cybersecurity risk assessment of the products.

Manufacturers shall keep the technical documentation and the EU declaration of conformity 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.

Manufacturers shall ensure that their products with digital elements bear a type, batch or serial number or other element allowing their identification, or, where that is not possible, that that information is provided on their packaging or in a document accompanying the product with digital elements.

Manufacturers shall indicate the name, registered trade name or registered trademark of the manufacturer, and the postal address, email address or other digital contact details, as well as, where applicable, the website where the manufacturer can be contacted, on the product with digital elements, on its packaging or in a document accompanying the product with digital elements. That information shall also be included in the information and instructions to the user set out in Annex II. The contact details shall be in a language which can be easily understood by users and market surveillance authorities.

Manufacturers shall ensure that products with digital elements are accompanied by the information and instructions to the user set out in Annex II, in paper or electronic form. Such information and instructions shall be provided in a language which can be easily understood by users and market surveillance authorities. They shall be clear, understandable, intelligible and legible. They shall allow for the secure installation, operation and use of products with digital elements. Manufacturers shall keep the information and instructions to the user set out in Annex II at the disposal of users and 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. Where such information and instructions are provided online, manufacturers shall ensure that they are accessible, user-friendly and available online 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.

Manufacturers shall either provide a copy of the EU declaration of conformity or a simplified EU declaration of conformity with the product with digital elements. Where a simplified EU declaration of conformity is provided, it shall contain the exact internet address at which the full EU declaration of conformity can be accessed.

Manufacturers shall, upon a reasoned request from a market surveillance authority, provide that authority, in a language which can be easily understood by that authority, with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of the product with digital elements and of the processes put in place by the manufacturer with the essential cybersecurity requirements set out in Annex I. Manufacturers shall cooperate with that authority, at its request, on any measures taken to eliminate the cybersecurity risks posed by the product with digital elements which they have placed on the market.

Notifications

These reporting requirements aim to enhance cybersecurity measures and enable coordinated responses to vulnerabilities and incidents. Consequently, manufacturers must:

  • Inform CSIRT within 24 hours vulnerabilities in their products. Details of the vulnerability and any corrective actions taken should be included.
  • Notify CSIRT within 24 hours of incidents impacting product security. Information on severity, impact, and suspected unlawful acts should be included. The market surveillance authority should be informed.
  • Quickly inform users about incidents and provide mitigation measures.
  • Report vulnerabilities in integrated components to the respective maintainers.
 

While the Cyber Resilience Act has been adopted, the reporting requirements will only become mandatory and enforceable in 2027, following a transitional period.

Base juridique

A manufacturer shall notify any actively exploited vulnerability contained in the product with digital elements that it becomes aware of simultaneously to the CSIRT designated as coordinator, in accordance with paragraph 7 of this Article, and to ENISA. The manufacturer shall notify that actively exploited vulnerability via the single reporting platform established pursuant to Article 16.

For the purposes of the notification referred to in paragraph 1, the manufacturer shall submit:

(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) à moins que les informations pertinentes n'aient déjà été fournies, un rapport final, au plus tard 14 jours après qu'une mesure corrective ou d'atténuation est disponible, comprenant au moins les éléments suivants :

(i) une description de la vulnérabilité, y compris sa gravité et son impact ;

(ii) le cas échéant, des informations concernant tout acteur malveillant qui a exploité ou qui exploite la vulnérabilité ;

(iii) des détails sur la mise à jour de sécurité ou d'autres mesures correctives qui ont été mises à disposition pour remédier à la vulnérabilité.

A manufacturer shall notify any severe incident having an impact on the security of the product with digital elements that it becomes aware of simultaneously to the CSIRT designated as coordinator, in accordance with paragraph 7 of this Article, and to ENISA. The manufacturer shall notify that incident via the single reporting platform established pursuant to Article 16.

For the purposes of the notification referred to in paragraph 3, the manufacturer shall submit:

(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.

The notifications referred to in paragraphs 1 and 3 of this Article shall be submitted via the single reporting platform referred to in Article 16 using one of the electronic notification end-points referred to in Article 16(1). The notification shall be submitted using the electronic notification end-point of the CSIRT designated as coordinator of the Member State where the manufacturers have their main establishment in the Union and shall be simultaneously accessible to ENISA.

For the purposes of this Regulation, a manufacturer shall be considered to have its main establishment in the Union in the Member State where the decisions related to the cybersecurity of its products with digital elements are predominantly taken. If such a Member State cannot be determined, the main establishment shall be considered to be in the Member State where the manufacturer concerned has the establishment with the highest number of employees in the Union.

Where a manufacturer has no main establishment in the Union, it shall submit the notifications referred to in paragraphs 1 and 3 using the electronic notification end-point of the CSIRT designated as coordinator in the Member State determined pursuant to the following order and based on the information available to the manufacturer:

(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. In relation to the third subparagraph, point (d), a manufacturer may submit notifications related to any subsequent actively exploited vulnerability or severe incident having an impact on the security of the product with digital elements to the same CSIRT designated as coordinator to which it first reported.

After becoming aware of an actively exploited vulnerability or a severe incident having an impact on the security of the product with digital elements, the manufacturer shall inform the impacted users of the product with digital elements, and where appropriate all users, of that vulnerability or incident and, where necessary, of any risk mitigation and corrective measures that the users can deploy to mitigate the impact of that vulnerability or incident, where appropriate in a structured, machine-readable format that is easily automatically processable. Where the manufacturer fails to inform the users of the product with digital elements in a timely manner, the notified CSIRTs designated as coordinators may provide such information to the users when considered to be proportionate and necessary for preventing or mitigating the impact of that vulnerability or incident.

Manufacturers as well as other natural or legal persons may notify any vulnerability contained in a product with digital elements as well as cyber threats that could affect the risk profile of a product with digital elements on a voluntary basis to a CSIRT designated as coordinator or ENISA.

Manufacturers as well as other natural or legal persons may notify any incident having an impact on the security of the product with digital elements as well as near misses that could have resulted in such an incident on a voluntary basis to a CSIRT designated as coordinator or ENISA.

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