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Relevant Union law in force comprises several sets of horizontal rules that address certain aspects linked to cybersecurity from different angles, including measures to improve the security of the digital supply chain. However, existing Union law related to cybersecurity, including Regulation (EU) 2019/881 of the European Parliament and of the Council1 and Directive (EU) 2022/2555 of the European Parliament and of the Council2, does not directly cover mandatory requirements for the security of products with digital elements.

By laying down cybersecurity requirements for placing on the market products with digital elements, it is intended that the cybersecurity of those products for consumers and businesses alike be enhanced. Those requirements will also ensure that cybersecurity is taken into account throughout supply chains, making final products with digital elements and their components more secure. This also includes requirements for placing on the market consumer products with digital elements intended for vulnerable consumers, such as toys and baby monitoring systems. Consumer products with digital elements categorised in this Regulation as important products with digital elements present a higher cybersecurity risk...

Under certain conditions, all products with digital elements integrated in or connected to a larger electronic information system can serve as an attack vector for malicious actors. As a result, even hardware and software considered to be less critical can facilitate the initial compromise of a device or network, enabling malicious actors to gain privileged access to a system or to move laterally across systems. Manufacturers should therefore ensure that all products with digital elements are designed and developed in accordance with the essential cybersecurity requirements laid down in this Regulation. That obligation relates to both products that can be...

To increase the overall level of cybersecurity of all products with digital elements placed on the internal market, it is necessary to introduce objective-oriented and technology-neutral essential cybersecurity requirements for those products that apply horizontally.

At Union level, various programmatic and political documents, such as the Joint communication of the Commission and the High Representative of the Union for Foreign Affairs and Security Policy of 16 December 2020, entitled ‘The EU’s Cybersecurity Strategy for the Digital Decade’, the Council Conclusions of 2 December 2020 on the cybersecurity of connected devices and of 23 May 2022 on the development of the European Union’s cyber posture and the European Parliament resolution of 10 June 2021 on the EU’s Cybersecurity Strategy for the Digital Decade1, have called for specific Union cybersecurity requirements for digital or connected products, with...

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.

Directive (EU) 2022/2555 of the European Parliament and of the Council of 14 December 2022 on measures for a high common level of cybersecurity across the Union, amending Regulation (EU) No 910/2014 and Directive (EU) 2018/1972, and repealing Directive (EU) 2016/1148 (NIS 2 Directive) (OJ L 333, 27.12.2022, p. 80).

While existing Union law applies to certain products with digital elements, there is no horizontal Union regulatory framework establishing comprehensive cybersecurity requirements for all products with digital elements. The various acts and initiatives taken thus far at Union and national levels only partially address the identified cybersecurity-related problems and risks, creating a legislative patchwork within the internal market, increasing legal uncertainty for both manufacturers and users of those products and adding an unnecessary burden on businesses and organisations to comply with a number of requirements and obligations for similar types of products. The cybersecurity of those products has a particularly...

This Regulation aims to set the boundary conditions for the development of secure products with digital elements by ensuring that hardware and software products are placed on the market with fewer vulnerabilities and that manufacturers take security seriously throughout a product’s lifecycle. It also aims to create conditions allowing users to take cybersecurity into account when selecting and using products with digital elements, for example by improving transparency with regard to the support period for products with digital elements made available on the market.

Cybersecurity is one of the key challenges for the Union. The number and variety of connected devices will rise exponentially in the coming years. Cyberattacks represent a matter of public interest as they have a critical impact not only on the Union’s economy, but also on democracy as well as consumer safety and health. It is therefore necessary to strengthen the Union’s approach to cybersecurity, address cyber resilience at Union level and improve the functioning of the internal market by laying down a uniform legal framework for essential cybersecurity requirements for placing products with digital elements on the Union market....