Article 21 Cases in which obligations of manufacturers apply to importers and distributors

An 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 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; 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 and shall be subject to Articles 13 and 14, where that 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 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; places 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; on the market under its name or trademark or 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; already placed on the market.