Article 5 · Commission Delegated Regulation (EU) 2024/370

Contents

Article 5Requirements relating to notified bodies#

1.For the purposes of notification, a conformity assessment body shall meet the requirements laid down in this Article.

10.Conformity assessment bodies shall take out liability insurance unless liability is assumed by the State in accordance with national law, or the Member State itself is directly responsible for the conformity assessment.

11.The personnel of a conformity assessment body shall observe professional secrecy with regard to all information obtained in carrying out their tasks under Article 2, except in relation to the competent authorities of the Member State in which its activities are carried out. Proprietary rights shall be protected.

12.Conformity assessment bodies shall participate in, or ensure that their personnel responsible for carrying out the conformity assessment tasks are informed of, relevant standardisation activities.

2.A conformity assessment body shall be established under national law and have legal personality.

3.A conformity assessment body shall be a third-party body independent of the manufacturer’s, the importer’s or the authorised representative’s organisation or the products it assesses.

4.A conformity assessment body shall be accredited by a national accreditation body in accordance with Regulation (EC) No 765/2008. The accreditation shall be based on international standard EN ISO/IEC 17065:2017. The accreditation certificate shall attest that the conformity assessment body is competent to perform the conformity assessment procedures referred to in Article 2 of this Regulation.

5.A conformity assessment body, its top-level management and the personnel responsible for carrying out the conformity assessment tasks shall not be the designer, manufacturer, importer, supplier, purchaser, owner or user of products which they assess, nor the authorised representative of any of those parties. This shall not preclude the use of products that are necessary for the operations of the conformity assessment body or the use of products for personal purposes.A conformity assessment body, its top-level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture, marketing or use of products which they assess or represent 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 activities for which they are notified. This shall in particular apply to consultancy services.Conformity assessment bodies shall ensure that the activities of their subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment activities.

6.Conformity assessment bodies and their personnel shall carry out the conformity assessment 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 activities, especially as regards persons or groups of persons with an interest in the results of those activities.

7.A conformity assessment body shall be capable of carrying out all the conformity assessment tasks which are assigned to it by Article 2 and in relation to which they have been notified, whether those tasks are carried out by the conformity assessment body itself or on its behalf and under its responsibility.At all times and for each conformity assessment procedure and each product in relation to which it has been notified, a conformity assessment body shall have at its disposal, or in place, the necessary:

(a)personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks;

(b)descriptions of procedures in accordance with which the conformity assessment is carried out, ensuring the transparency and the ability of reproduction of those procedures;

(c)policies and procedures that distinguish between tasks it carries out as a notified body and other activities;

(d)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 shall have the means necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and shall have access to all necessary equipment or facilities.

8.The personnel responsible for carrying out the conformity assessment tasks shall have the following:

(a)sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been notified;

(b)satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments;

(c)appropriate knowledge and understanding of the minimum hygiene requirements and their standards set out in Implementing Decision (EU) 2024/368; and

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

9.The impartiality of the conformity assessment bodies, their top-level management and of the personnel responsible for carrying out the conformity assessment tasks shall be guaranteed.The remuneration of the top-level management and the personnel responsible for carrying out the conformity assessment tasks of a conformity assessment body shall not depend on the number of assessments carried out or on the results of those assessments.