Article 26 Guidance

The Commission should provide guidance to assist economic operators, in particular microenterprises and small and medium-sized enterprises, in the application of this Regulation. Such guidance should cover, inter alia, the scope of this Regulation, in particular remote data processing and its implications for free and open-source software developers, the application of the criteria used to determine support periods for products with digital elements, the interplay between this Regulation and other Union law and the concept of substantial modification.

In order to ensure that products with digital elements, when placed on the market, do not pose cybersecurity risks to persons and organisations, essential cybersecurity requirements should be set out for such products. Those essential cybersecurity requirements, including vulnerability management handling requirements, apply to each individual product with digital elements when placed on the market, irrespective of whether the product with digital elements is manufactured as an individual unit or in series. For example, for a product type, each individual product with digital elements should have received all security patches or updates available to address relevant security issues when it is placed on the market. Where products with digital elements are subsequently modified, by physical or digital means, in a way that is not foreseen by the manufacturer in the initial risk assessment and that may imply that they no longer meet the relevant essential cybersecurity requirements, the modification should be considered to be substantial. For example, repairs could be assimilated to maintenance operations provided that they do not modify a product with digital elements already placed on the market in such a way that compliance with the applicable requirements may be affected, or that the intended purpose 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 to be substantially modified by a software change where the software update modifies the intended purpose of that product and those changes were not foreseen by the manufacturer in the initial risk assessment, or where the nature of the hazard has changed or the level of cybersecurity risk has increased because of the software update, and the updated version of the product is made available on the market. Where a security update which is designed to decrease the level of cybersecurity risk of a product with digital elements does not modify the intended purpose of a product with digital elements, it is not considered to be a substantial modification. This usually includes situations where a security update entails only minor adjustments of the source code. For example, this could be the case where a security update addresses a known vulnerability, including by modifying functions or the performance of a product with digital elements for the sole purpose of decreasing the level of cybersecurity risk. Similarly, a minor functionality update, such as a visual enhancement or the addition of new pictograms or languages to the user interface, should not generally be considered to be a substantial modification. Conversely, where a feature update modifies the original intended functions or the type or performance of a product with digital elements and meets the above criteria, it should be considered to be a substantial modification, as the addition of new features typically leads to a broader attack surface, thereby increasing the cybersecurity risk. For example, this could be the case where a new input element is added to an application, requiring the manufacturer to ensure adequate input validation. In assessing whether a feature update is considered to be a substantial modification it is not relevant whether it is provided as a separate update or in combination with a security update. The Commission should issue guidance on how to determine what constitutes a substantial modification.

Taking into account the iterative nature of software development, manufacturers that have placed subsequent versions of a software product on the market as a result of a subsequent substantial modification of that product should be able to provide security updates for the support period only for the version of the software product that they have last placed on the market. They should be able to do so only if the users of the relevant previous product versions have access to the product version last placed on the market free of charge and do not incur additional costs to adjust the hardware or software environment in which they operate the product. This could, for instance, be the case where a desktop operating system upgrade does not require new hardware, such as a faster central processing unit or more memory. Nonetheless, the manufacturer should continue to comply, for the support period, with other vulnerability-handling requirements, such as having a policy on coordinated vulnerability disclosure or measures in place to facilitate the sharing of information about potential vulnerabilities for all subsequent substantially modified versions of the software product placed on the market. Manufacturers should be able to provide minor security or functionality updates that do not constitute a substantial modification only for the latest version or sub-version of a software product that has not been substantially modified. At the same time, where a hardware product, such as a smartphone, is not compatible with the latest version of the operating system it was originally delivered with, the manufacturer should continue to provide security updates at least for the latest compatible version of the operating system for the support period.

In line with the commonly established concept of substantial modification for products regulated by Union harmonisation legislation, where a substantial modification occurs that may affect the compliance of a product with digital elements 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, a change that might lead to a substantial modification should be notified to the third party.

Where a product with digital elements is subject to ‘refurbishment’, ‘maintenance’ and ‘repair’ as defined in Article 2, points (18), (19) and (20), of Regulation (EU) 2024/1781 of the European Parliament and of the Council(¹⁹), this does not necessarily lead to a substantial modification of the product, for instance if the intended purpose and functionalities are not changed and the level of risk remains unaffected. However, an upgrade of a product with digital elements by the manufacturer might lead to changes in the design and development of that product and might therefore affect its intended purpose and compliance with the requirements set out in this Regulation.

Important products with digital elements as referred to in this Regulation should be understood as products which have the core functionality of a category of important products with digital elements that is set out in this Regulation. For example, this Regulation sets out categories of important products with digital elements which are defined by their core functionality as firewalls or intrusion detection or prevention systems in class II. As a result, firewalls and intrusion detection or prevention systems are subject to mandatory third-party conformity assessment. This is not the case for other products with digital elements not categorised as important products with digital elements which may integrate firewalls or intrusion detection or prevention systems. The Commission should adopt an implementing act to specify the technical description of the categories of important products with digital elements that fall under classes I and II as set out in this Regulation.

For the purpose of ensuring the security of products with digital elements after their placing on the market, manufacturers should determine the support period, which should reflect the time the product with digital elements is expected to be in use. In determining a support period, a manufacturer should take into account in particular reasonable user expectations, the nature of the product, as well as relevant Union law determining the lifetime of products with digital elements. Manufacturers should also be able to take into account other relevant factors. Criteria should be applied in a manner that ensures proportionality in the determination of the support period. Upon request, a manufacturer should provide market surveillance authorities with the information that was taken into account to determine the support period of a product with digital elements.

The support period for which the manufacturer ensures the effective handling of vulnerabilities should be no less than five years, unless the lifetime of the product with digital elements is less than five years, in which case the manufacturer should ensure the vulnerability handling for that lifetime. Where the time the product with digital elements is reasonably expected to be in use is longer than five years, as is often the case for hardware components such as motherboards or microprocessors, network devices such as routers, modems or switches, as well as software, such as operating systems or video-editing tools, manufacturers should accordingly ensure longer support periods. In particular, products with digital elements intended for use in industrial settings, such as industrial control systems, are often in use for significantly longer periods of time. A manufacturer should be able to define a support period of less than five years only where this is justified by the nature of the product with digital elements concerned and where that product is expected to be in use for less than five years, in which case the support period should correspond to the expected use time. For instance, the lifetime of a contact tracing application intended for use during a pandemic could be limited to the duration of the pandemic. Moreover, some software applications can by nature only be made available on the basis of a subscription model, in particular where the application becomes unavailable to the user and is consequently not in use anymore once the subscription expires.

When products with digital elements reach the end of their support periods, in order to ensure that vulnerabilities can be handled after the end of the support period, manufacturers should consider releasing the source code of such products with digital elements either to other undertakings which commit to extending the provision of vulnerability handling services or to the public. Where manufacturers release the source code to other undertakings, they should be able to protect the ownership of the product with digital elements and prevent the dissemination of the source code to the public, for example through contractual arrangements.

In order to ensure that manufacturers across the Union determine similar support periods for comparable products with digital elements, ADCO should publish statistics on the average support periods determined by manufacturers for categories of products with digital elements and issue guidance indicating appropriate support periods for such categories. In addition, with a view to ensuring a harmonised approach across the internal market, the Commission should be able to adopt delegated acts to specify minimum support periods for specific product categories where the data provided by market surveillance authorities suggests that the support periods determined by manufacturers are either systematically not in line with the criteria for determining the support periods as laid down in this Regulation or that manufacturers in different Member States unjustifiably determine different support periods.