Article 35 Notification

In order to ensure a smooth application of this Regulation, Member States should strive to ensure, before the date of application of this Regulation, that a sufficient number of notified bodiesmeans a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; is available to carry out third-party conformity assessmentsmeans the process of verifying whether the essential cybersecurity requirements set out in Annex I have been fulfilled;. The Commission should seek to assist Member States and other relevant parties in this endeavour, in order to avoid bottlenecks and hindrances to market entry for manufacturersmeans 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;. Targeted training activities led by Member States, including where appropriate with the support of the Commission, can contribute to the availability of skilled professionals including to support the activities of notified bodiesmeans a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; under this Regulation. Furthermore, in light of the costs that third-party conformity assessmentmeans the process of verifying whether the essential cybersecurity requirements set out in Annex I have been fulfilled; may entail, funding initiatives at Union and national level that seek to alleviate such costs for 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 enterprises should be considered.

In order to carry out third-party conformity assessmentmeans the process of verifying whether the essential cybersecurity requirements set out in Annex I have been fulfilled; for 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;, conformity assessment bodiesmeans a conformity assessment body as defined in Article 2, point (13), of Regulation (EC) No 765/2008; should be notified by the national notifying authoritiesmeans the national authority responsible for setting up and carrying out the necessary procedures for the assessment, designation and notification of conformity assessment bodies and for their monitoring; to the Commission and the other Member States, provided they comply with a set of requirements, in particular on independence, competence and absence of conflicts of interest.