Autor: Luka Prgomet

The purpose of this Regulation is to ensure a high level of cybersecurity of products with digital elements and their integrated remote data processing solutions. Such remote data processing solutions should be defined as data processing at a distance for which the software is designed and developed by or on behalf of the manufacturer of the product with digital elements concerned, the absence of which would prevent the product with digital elements from performing one of its functions. That approach ensures that such products are adequately secured in their entirety by their manufacturers, irrespective of whether data is processed or...

In line with the objective of this Regulation to remove obstacles to the free movement of products with digital elements, Member States should not impede, for the matters covered by this Regulation, the making available on the market of products with digital elements which comply with this Regulation. Therefore, for matters harmonised by this Regulation, Member States cannot impose additional cybersecurity requirements for the making available on the market of products with digital elements. Any entity, public or private, can however establish additional requirements to those laid down in this Regulation for the procurement or use of products with digital...

Products with digital elements provided as part of the delivery of a service for which a fee is charged solely to recover the actual costs directly related to the operation of that service, such as may be the case with certain products with digital elements provided by public administration entities, should not be considered on those grounds alone to be a commercial activity for the purposes of this Regulation. Furthermore, products with digital elements which are developed or modified by a public administration entity exclusively for its own use should not be considered to be made available on the market...

Software and data that are openly shared and where users can freely access, use, modify and redistribute them or modified versions thereof, can contribute to research and innovation in the market. To foster the development and deployment of free and open-source software, in particular by microenterprises and small and medium-sized enterprises, including start-ups, individuals, not-for-profit organisations, and academic research organisations, the application of this Regulation to products with digital elements qualifying as free and open-source software supplied for distribution or use in the course of a commercial activity should take into account the nature of the different development models of...

Free and open-source software is understood as software the source code of which is openly shared and the licensing of which provides for all rights to make it freely accessible, usable, modifiable and redistributable. Free and open-source software is developed, maintained and distributed openly, including via online platforms. In relation to economic operators that fall within the scope of this Regulation, only free and open-source software made available on the market, and therefore supplied for distribution or use in the course of a commercial activity, should fall within the scope of this Regulation. The mere circumstances under which the product...

Taking into account the importance for cybersecurity of many products with digital elements qualifying as free and open-source software that are published, but not made available on the market within the meaning of this Regulation, legal persons who provide support on a sustained basis for the development of such products which are intended for commercial activities, and who play a main role in ensuring the viability of those products (open-source software stewards), should be subject to a light-touch and tailor-made regulatory regime. Open-source software stewards include certain foundations as well as entities that develop and publish free and open-source software...

The sole act of hosting products with digital elements on open repositories, including through package managers or on collaboration platforms, does not in itself constitute the making available on the market of a product with digital elements. Providers of such services should be considered to be distributors only if they make such software available on the market and hence supply it for distribution or use on the Union market in the course of a commercial activity.

In view of the public cybersecurity objectives of this Regulation and in order to improve the situational awareness of Member States as regards the Union’s dependency on software components and in particular on potentially free and open-source software components, a dedicated administrative cooperation group (ADCO) established by this Regulation should be able to decide to jointly undertake a Union dependency assessment. Market surveillance authorities should be able to request manufacturers of categories of products with digital elements established by ADCO to submit the software bills of materials (SBOMs) that they have generated pursuant to this Regulation. In order to protect...

In order to support and facilitate the due diligence of manufacturers that integrate free and open-source software components that are not subject to the essential cybersecurity requirements set out in this Regulation into their products with digital elements, the Commission should be able to establish voluntary security attestation programmes, either by a delegated act supplementing this Regulation or by requesting a European cybersecurity certification scheme pursuant to Article 48 of Regulation (EU) 2019/881 that takes into account the specificities of the free and open-source software development models. The security attestation programmes should be conceived in such a way that not...

The effectiveness of the implementation of this Regulation will also depend on the availability of adequate cybersecurity skills. At Union level, various programmatic and political documents, including the Commission communication of 18 April 2023 on Closing the cybersecurity talent gap to boost the EU’s competitiveness, growth and resilience and the Council Conclusions of 22 May 2023 on the EU Policy on Cyber Defence acknowledged the cybersecurity skills gap in the Union and the need to address such challenges as a matter of priority, in both the public and private sectors. With a view to ensuring an effective implementation of this...