Article 47 Operational obligations of notified bodies

Notified bodiesmeans a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; shall carry out conformity assessmentsmeans the process of verifying whether the essential cybersecurity requirements set out in Annex I have been fulfilled; in accordance with the conformity assessmentmeans the process of verifying whether the essential cybersecurity requirements set out in Annex I have been fulfilled; procedures provided for in Article 32 and Annex VIII.

Conformity assessmentsmeans the process of verifying whether the essential cybersecurity requirements set out in Annex I have been fulfilled; shall be carried out in a proportionate manner, avoiding unnecessary burdens for economic operatorsmeans the manufacturer, the authorised representative, the importer, the distributor, or other natural or legal person who is subject to obligations in relation to the manufacture of products with digital elements or to the making available of products with digital elements on the market in accordance with this Regulation;. Conformity assessment bodiesmeans a conformity assessment body as defined in Article 2, point (13), of Regulation (EC) No 765/2008; shall perform their activities taking due account of the size of undertakings, in particular as regards microenterprises, ‘small enterprises’ and ‘medium-sized enterprises’ mean, respectively, microenterprises, small enterprises and medium-sized enterprises as defined in the Annex to Recommendation 2003/361/EC; and small and medium-sized enterprises, the sector in which they operate, their structure, their degree of complexity and the cybersecurity riskmeans 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; level of the products 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 technology in question and the mass or serial nature of the production process.

Notified bodiesmeans a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; shall however respect the degree of rigour and the level of protection required for the compliance of products 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; with this Regulation.

Where a notified bodymeans a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; finds that the requirements set out in Annex I or in corresponding harmonised standardsmeans a harmonised standard as defined in Article 2, point (1)(c), of Regulation (EU) No 1025/2012; or common specifications as referred to in Article 27 have not been met by 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;, it shall require that 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; to take appropriate corrective measures and shall not issue a certificate of conformity.

Where, in the course of the monitoring of conformity following the issuance of a certificate, a notified bodymeans a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; finds that 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; no longer complies with the requirements laid down in this Regulation, it shall require 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; to take appropriate corrective measures and shall suspend or withdraw the certificate if necessary.

Where corrective measures are not taken or do not have the required effect, the notified bodymeans a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; shall restrict, suspend or withdraw any certificates, as appropriate.