Article 2 Scope


    1. This Regulation applies to products 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; made available on the market, the 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; or 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; of which includes a direct or indirect logical or physical data connection to a device or network.

    1. This Regulation does not apply to products 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; to which the following Union legal acts apply:

      1. Regulation (EU) 2017/745;

      2. Regulation (EU) 2017/746;

      3. Regulation (EU) 2019/2144.

    1. This Regulation does not apply to products 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; that have been certified in accordance with Regulation (EU) 2018/1139.

    1. This Regulation does not apply to equipment that falls within the scope of Directive 2014/90/EU of the European Parliament and of the Council (36)Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on marine equipment and repealing Council Directive 96/98/EC (OJ L 257, 28.8.2014, p. 146)..

    1. The application of this Regulation to products 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; covered by other Union rules laying down requirements that address all or some of the risks 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; covered by the essential cybersecurity means cybersecurity as defined in Article 2, point (1), of Regulation (EU) 2019/881; requirements set out in Annex I may be limited or excluded where:

      1. such limitation or exclusion is consistent with the overall regulatory framework that applies to those products; and

      2. the sectoral rules achieve the same or a higher level of protection as that provided for by this Regulation.

    2. The Commission is empowered to adopt delegated acts in accordance with Article 61 to supplement this Regulation by specifying whether such limitation or exclusion is necessary, the products and rules concerned, as well as the scope of the limitation, if relevant.

    1. This Regulation does not apply to spare parts that are made available on the market to replace identical components means software or hardware intended for integration into an electronic information system; in products 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; and that are manufactured according to the same specifications as the components means software or hardware intended for integration into an electronic information system; that they are intended to replace.

    1. This Regulation does not apply to products 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; developed or modified exclusively for national security or defence purposes or to products specifically designed to process classified information.

    1. The obligations laid down in this Regulation shall not entail the supply of information the disclosure of which would be contrary to the essential interests of Member States’ national security, public security or defence.

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