Article 58 Formal non-compliance


    1. Where the market surveillance authority means a market surveillance authority as defined in Article 3, point (4), of Regulation (EU) 2019/1020; of a Member State makes one of the following findings, it shall require the relevant 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; to put an end to the non-compliance concerned:

      1. 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; has been affixed in violation of Articles 29 and 30;

      2. 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; has not been affixed;

      3. the EU declaration of conformity has not been drawn up;

      4. the EU declaration of conformity has not been drawn up correctly;

      5. the identification number of the notified body means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; which is involved in the conformity assessment means the process of verifying whether the essential cybersecurity requirements set out in Annex I have been fulfilled; procedure, where applicable, has not been affixed;

      6. the technical documentation is either not available or not complete.

    1. Where the non-compliance referred to in paragraph 1 persists, the Member State concerned shall take all appropriate measures to restrict or prohibit 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being placed on the market separately; from being made available on the market or ensure that it is recalled or withdrawn from the market.

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