Article 22 Other cases in which obligations of manufacturers apply

A natural or legal person, other than the manufacturermeans 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;, the importermeans a natural or legal person established in the Union who places on the market a product with digital elements that bears the name or trademark of a natural or legal person established outside the Union; or the distributormeans a natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a product with digital elements available on the Union market without affecting its properties;, that carries out a substantial modificationmeans a change to the product with digital elements following its placing on the market, which affects the compliance of the product with digital elements with the essential cybersecurity requirements set out in Part I of Annex I or which results in a modification to the intended purpose for which the product with digital elements has been assessed; of a product with digital elementsmeans a software or hardware product and its remote data processing solutions, including software or hardware components being placed on the market separately; and makes that product available on the market, shall be considered to be a manufacturermeans 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; for the purposes of this Regulation.

The person referred to in paragraph 1 of this Article shall be subject to the obligations set out in Articles 13 and 14 for the part of the product with digital elementsmeans a software or hardware product and its remote data processing solutions, including software or hardware components being placed on the market separately; that is affected by the substantial modificationmeans a change to the product with digital elements following its placing on the market, which affects the compliance of the product with digital elements with the essential cybersecurity requirements set out in Part I of Annex I or which results in a modification to the intended purpose for which the product with digital elements has been assessed; or, if the substantial modificationmeans a change to the product with digital elements following its placing on the market, which affects the compliance of the product with digital elements with the essential cybersecurity requirements set out in Part I of Annex I or which results in a modification to the intended purpose for which the product with digital elements has been assessed; has an impact on the cybersecuritymeans cybersecurity as defined in Article 2, point (1), of Regulation (EU) 2019/881; of the product with digital elementsmeans a software or hardware product and its remote data processing solutions, including software or hardware components being placed on the market separately; as a whole, for the entire product.