Article 6 Requirements for products with digital elements


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; shall be made available on the market only where:

  1. they meet the essential cybersecurity means cybersecurity as defined in Article 2, point (1), of Regulation (EU) 2019/881; requirements set out in Part I of Annex I, provided that they are properly installed, maintained, used for their 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 under conditions which can reasonably be foreseen, and, where applicable, the necessary security updates have been installed; and

  2. the processes put in place by the manufacturer means a natural or legal person who develops or manufactures products with digital elements or has products with digital elements designed, developed or manufactured, and markets them under its name or trademark, whether for payment, monetisation or free of charge; comply with the essential cybersecurity means cybersecurity as defined in Article 2, point (1), of Regulation (EU) 2019/881; requirements set out in Part II of Annex I.

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