Article 39 Requirements relating to notified bodies

For the purposes of notification, a conformity assessment body means a conformity assessment body as defined in Article 2, point (13), of Regulation (EC) No 765/2008; shall meet the requirements laid down in paragraphs 2 to 12.

A conformity assessment body means a conformity assessment body as defined in Article 2, point (13), of Regulation (EC) No 765/2008; shall be established under national law and have legal personality.

A conformity assessment body means a conformity assessment body as defined in Article 2, point (13), of Regulation (EC) No 765/2008; shall be a third-party body independent of the organisation or 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; it assesses.

A body belonging to a business association or professional federation representing undertakings involved in the design, development, production, provision, assembly, use or maintenance of 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; which it assesses, may, on condition that its independence and the absence of any conflict of interest are demonstrated, be considered to be such a third-party body.

A conformity assessment body means a conformity assessment body as defined in Article 2, point (13), of Regulation (EC) No 765/2008;, its top level management and the personnel responsible for carrying out the conformity assessment means the process of verifying whether the essential cybersecurity requirements set out in Annex I have been fulfilled; tasks shall not be the designer, developer, 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;, supplier, 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;, distributor means 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;, installer, purchaser, owner, user or maintainer 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; which they assess, nor the authorised representative means a natural or legal person established within the Union who has received a written mandate from a manufacturer to act on its behalf in relation to specified tasks; of any of those parties. This shall not preclude the use of assessed products that are necessary for the operations of the conformity assessment body means a conformity assessment body as defined in Article 2, point (13), of Regulation (EC) No 765/2008; or the use of such products for personal purposes.

A conformity assessment body means a conformity assessment body as defined in Article 2, point (13), of Regulation (EC) No 765/2008;, its top level management and the personnel responsible for carrying out the conformity assessment means the process of verifying whether the essential cybersecurity requirements set out in Annex I have been fulfilled; tasks shall not be directly involved in the design, development, production, import, distribution, the marketing, installation, use or maintenance 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; which they assess, or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment means the process of verifying whether the essential cybersecurity requirements set out in Annex I have been fulfilled; activities for which they are notified. This shall in particular apply to consultancy services.

Conformity assessment bodies means a conformity assessment body as defined in Article 2, point (13), of Regulation (EC) No 765/2008; shall ensure that the activities of their subsidiaries means a subsidiary undertaking within the meaning of Article 2, point (10), and Article 22 of Directive 2013/34/EU; or subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment means the process of verifying whether the essential cybersecurity requirements set out in Annex I have been fulfilled; activities.

Conformity assessment bodies means a conformity assessment body as defined in Article 2, point (13), of Regulation (EC) No 765/2008; and their personnel shall carry out the conformity assessment means the process of verifying whether the essential cybersecurity requirements set out in Annex I have been fulfilled; activities with the highest degree of professional integrity and the requisite technical competence in the specific field and shall be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of their conformity assessment means the process of verifying whether the essential cybersecurity requirements set out in Annex I have been fulfilled; activities, especially as regards persons or groups means a group as defined in Article 2, point (11), of Directive 2013/34/EU; of persons with an interest in the results of those activities.

A conformity assessment body means a conformity assessment body as defined in Article 2, point (13), of Regulation (EC) No 765/2008; shall be capable of carrying out all the conformity assessment means the process of verifying whether the essential cybersecurity requirements set out in Annex I have been fulfilled; tasks referred to in Annex VIII and in relation to which it has been notified, regardless of whether those tasks are carried out by the conformity assessment body means a conformity assessment body as defined in Article 2, point (13), of Regulation (EC) No 765/2008; itself or on its behalf and under its responsibility.

1. personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment means the process of verifying whether the essential cybersecurity requirements set out in Annex I have been fulfilled; tasks;

2. descriptions of procedures in accordance with which conformity assessment means the process of verifying whether the essential cybersecurity requirements set out in Annex I have been fulfilled; is to be carried out, ensuring the transparency of and ability to reproduce those procedures. It shall have appropriate policies and procedures in place that distinguish between tasks it carries out as a notified body means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; and other activities;

3. procedures for the performance of activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the production process.

A conformity assessment body means a conformity assessment body as defined in Article 2, point (13), of Regulation (EC) No 765/2008; shall have the means necessary to perform the technical and administrative tasks connected with the conformity assessment means the process of verifying whether the essential cybersecurity requirements set out in Annex I have been fulfilled; activities in an appropriate manner and shall have access to all necessary equipment or facilities.

1. sound technical and vocational training covering all the conformity assessment means the process of verifying whether the essential cybersecurity requirements set out in Annex I have been fulfilled; activities in relation to which the conformity assessment body means a conformity assessment body as defined in Article 2, point (13), of Regulation (EC) No 765/2008; has been notified;

2. satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments;

3. appropriate knowledge and understanding of the essential cybersecurity means cybersecurity as defined in Article 2, point (1), of Regulation (EU) 2019/881; requirements set out in Annex I, of the applicable harmonised standards means a harmonised standard as defined in Article 2, point (1)(c), of Regulation (EU) No 1025/2012; and common specifications, and of the relevant provisions of Union harmonisation legislation means Union legislation listed in Annex I to Regulation (EU) 2019/1020 and any other Union legislation harmonising the conditions for the marketing of products to which that Regulation applies; and implementing acts;

4. the ability to draw up certificates, records and reports demonstrating that assessments have been carried out.

The impartiality of the conformity assessment bodies means a conformity assessment body as defined in Article 2, point (13), of Regulation (EC) No 765/2008;, their top level management and of the assessment personnel shall be guaranteed.

The remuneration of the top level management and assessment personnel of a conformity assessment body means a conformity assessment body as defined in Article 2, point (13), of Regulation (EC) No 765/2008; shall not depend on the number of assessments carried out or on the results of those assessments.

Conformity assessment bodies means a conformity assessment body as defined in Article 2, point (13), of Regulation (EC) No 765/2008; shall take out liability insurance unless liability is assumed by their Member State in accordance with national law, or the Member State itself is directly responsible for the conformity assessment means the process of verifying whether the essential cybersecurity requirements set out in Annex I have been fulfilled;.

The personnel of a conformity assessment body means a conformity assessment body as defined in Article 2, point (13), of Regulation (EC) No 765/2008; shall observe professional secrecy with regard to all information obtained in carrying out their tasks under Annex VIII or any provision of national law giving effect to it, except in relation to the market surveillance authorities means a market surveillance authority as defined in Article 3, point (4), of Regulation (EU) 2019/1020; of the Member State in which its activities are carried out. Proprietary rights shall be protected. The conformity assessment body means a conformity assessment body as defined in Article 2, point (13), of Regulation (EC) No 765/2008; shall have documented procedures ensuring compliance with this paragraph.

Conformity assessment bodies means a conformity assessment body as defined in Article 2, point (13), of Regulation (EC) No 765/2008; shall participate in, or ensure that their assessment personnel are informed of, the relevant standardisation activities and the activities of the notified body means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; coordination group means a group as defined in Article 2, point (11), of Directive 2013/34/EU; established under Article 51 and apply as general guidance the administrative decisions and documents produced as a result of the work of that group means a group as defined in Article 2, point (11), of Directive 2013/34/EU;.

Conformity assessment bodies means a conformity assessment body as defined in Article 2, point (13), of Regulation (EC) No 765/2008; shall operate in accordance with a set of consistent, fair, proportionate and reasonable terms and conditions, while avoiding unnecessary burden for economic operators means 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;, in particular taking into account the interests of 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 means a financial entity that is not a small enterprise and employs fewer than 250 persons and has an annual turnover that does not exceed EUR 50 million and/or an annual balance sheet that does not exceed EUR 43 million; in relation to fees.