Article 19 Obligations of importers

Importers means 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; shall place on the market only 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 comply with 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 and where 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.

1. the appropriate conformity assessment means the process of verifying whether the essential cybersecurity requirements set out in Annex I have been fulfilled; procedures as referred to in Article 32 have been carried out 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;;

2. 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; has drawn up the technical documentation;

3. the product 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; bears the CE marking means a marking by which a manufacturer indicates that a product with digital elements and the processes put in place by the manufacturer are in conformity with the essential cybersecurity requirements set out in Annex I and other applicable Union harmonisation legislation providing for its affixing; referred to in Article 30 and is accompanied by the EU declaration of conformity referred to in Article 13(20) and the information and instructions to the user as set out in Annex II in a language which can be easily understood by users and market surveillance authorities means a market surveillance authority as defined in Article 3, point (4), of Regulation (EU) 2019/1020;;

4. 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; has complied with the requirements set out in Article 13(15), (16) and (19).

For the purposes of this paragraph, importers means 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; shall be able to provide the necessary documents proving the fulfilment of the requirements set out in this Article.

Where an importer means 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; considers or has reason to believe that a product 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; or 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; are not in conformity with this Regulation, the importer means 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; shall not place the product on the market until that product or 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; have been brought into conformity with this Regulation. Furthermore, where the product 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; presents a significant cybersecurity risk means a cybersecurity risk which, based on its technical characteristics, can be assumed to have a high likelihood of an incident that could lead to a severe negative impact, including by causing considerable material or non-material loss or disruption;, the importer means 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; shall inform 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; and the market surveillance authorities means a market surveillance authority as defined in Article 3, point (4), of Regulation (EU) 2019/1020; to that effect.

Where an importer means 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; has reason to believe that a product 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; may present a significant cybersecurity risk means a cybersecurity risk which, based on its technical characteristics, can be assumed to have a high likelihood of an incident that could lead to a severe negative impact, including by causing considerable material or non-material loss or disruption; in light of non-technical risk 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; factors, the importer means 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; shall inform the market surveillance authorities means a market surveillance authority as defined in Article 3, point (4), of Regulation (EU) 2019/1020; to that effect. Upon receipt of such information, the market surveillance authorities means a market surveillance authority as defined in Article 3, point (4), of Regulation (EU) 2019/1020; shall follow the procedures referred to in Article 54(2).

Importers means 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; shall indicate their name, registered trade name or registered trademark, the postal address, email address or other digital contact as well as, where applicable, the website at which they can be contacted on the product 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; or on its packaging or in a document accompanying the product 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;. The contact details shall be in a language easily understood by users and market surveillance authorities means a market surveillance authority as defined in Article 3, point (4), of Regulation (EU) 2019/1020;.

Importers means 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; who know or have reason to believe that a product 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; which they have placed on the market is not in conformity with this Regulation shall immediately take the corrective measures necessary to ensure that the product 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; is brought into conformity with this Regulation, or to withdraw or recall means recall as defined in Article 3, point (22), of Regulation (EU) 2019/1020; the product, if appropriate.

Upon becoming aware of a vulnerability means a weakness, susceptibility or flaw of a product with digital elements that can be exploited by a cyber threat; in the product 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;, importers means 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; shall inform 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; without undue delay about that vulnerability means a weakness, susceptibility or flaw of a product with digital elements that can be exploited by a cyber threat;. Furthermore, where the product 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; presents a significant cybersecurity risk means a cybersecurity risk which, based on its technical characteristics, can be assumed to have a high likelihood of an incident that could lead to a severe negative impact, including by causing considerable material or non-material loss or disruption;, importers means 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; shall immediately inform the market surveillance authorities means a market surveillance authority as defined in Article 3, point (4), of Regulation (EU) 2019/1020; of the Member States in which they have made the product 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; available on the market to that effect, giving details, in particular, of non-compliance and of any corrective measures taken.

Importers means 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; shall, for at least 10 years after the product 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; has been placed on the market or for the support period means the period during which a manufacturer is required to ensure that vulnerabilities of a product with digital elements are handled effectively and in accordance with the essential cybersecurity requirements set out in Part II of Annex I;, whichever is longer, keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities means a market surveillance authority as defined in Article 3, point (4), of Regulation (EU) 2019/1020; and ensure that the technical documentation can be made available to those authorities, upon request.

Importers means 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; shall, further to a reasoned request from a market surveillance authority means a market surveillance authority as defined in Article 3, point (4), of Regulation (EU) 2019/1020;, provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of the product 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; with 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 as well as of 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; 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 in a language that can be easily understood by that authority. They shall cooperate with that authority, at its request, on any measures taken to eliminate the cybersecurity 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; posed by a product 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;, which they have placed on the market.

Where the importer means 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; of a product 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; becomes aware that 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; of that product has ceased its operations and, as result, is not able to comply with the obligations laid down in this Regulation, the importer means 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; shall inform the relevant market surveillance authorities means a market surveillance authority as defined in Article 3, point (4), of Regulation (EU) 2019/1020; about this situation, as well as, by any means available and to the extent possible, the users of the 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; placed on the market.