ANNEX III

MINIMUM ELIGIBILITY CRITERIA FOR NOTIFIED BODIES

1. For the purposes of notification, a conformity assessment body, a body entitled to carry out or supervise the conformity assessment procedure on specifications and suitability for use of interoperability constituents, must comply with paragraphs 2 to 11 of this Annex. The body must be accredited in accordance with Regulation (EC) No 765/2008 (1) for the harmonised European standard for conformity assessment on requirements for bodies certifying products, processes and services.

2. The body must be established under national law and have legal personality.

3. The body must be a third-party body independent of the organisation or the product it assesses. A body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of products which it assesses, may, if its independence and the absence of any conflict of interest are demonstrated, be considered such a body.

4. The body, its top-level management and the staff responsible for carrying out the conformity assessment tasks cannot be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of the products that they assess, nor the authorised representative of any of those parties. This must not preclude the use of assessed products that are necessary for the operations of the conformity assessment body or the use of such products for personal purposes. The body, its top-level management and the staff responsible for carrying out the conformity assessment tasks must not be directly involved in the design, manufacture or construction, the marketing, installation, use or maintenance of those products, or represent the parties engaged in those activities. They must 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. In particular this must apply to consultancy services. Conformity assessment bodies must ensure that the activities of their subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment activities.

5. Conformity assessment bodies and their staff must carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical competence in the specific field. They must also 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.

6. The body must be capable of carrying out all the conformity assessment tasks assigned to it under Directive 2019/520/EU and the relevant implementing acts and in relation to which it has 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 kind or category of products in relation to which it has been notified, a conformity assessment body must have at its disposal the necessary: (a) staff with technical knowledge and sufficient and relevant experience to perform the conformity assessment tasks; (b) descriptions of procedures governing the way a conformity assessment is carried out, ensuring the transparency and the ability of reproduction of those procedures. It must have appropriate policies and procedures in place that distinguish between the tasks it carries out as a notified body and other activities; and (c) procedures for the performance of activities that take 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. It shall be able to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and must have access to all necessary equipment or facilities.

7. The staff responsible for carrying out conformity assessment activities must have the following: (a) adequate technical and vocational training covering all the conformity assessment activities for which the conformity assessment body has been notified; (b) satisfactory knowledge of the requirements of the assessments they carry out and sufficient authority to carry out those assessments; (c) sufficient knowledge and understanding of the essential requirements, of the applicable standards and of the relevant provisions of EU harmonisation legislation and of its implementing regulations; and (d) the ability to draw up certificates, records and reports demonstrating that assessments have been carried out.

8. The impartiality of the conformity assessment bodies, their top-level management and of the assessment personnel must be guaranteed. The salaries of the top-level management and staff carrying out the assessments cannot depend on the number of assessments carried out or on the results of those assessments.

9. Conformity assessment bodies must 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.

10. The conformity assessment body staff must comply with professional secrecy for all information obtained in carrying out their tasks under Directive 2019/520/EU and the relevant implementing acts or any national law giving effect to it. However, this does not apply to the competent authorities of the Member State in which its activities are carried out. Proprietary rights must be protected.

11. Conformity assessment bodies must participate in, or ensure that staff carrying out the assessment are informed of, the relevant standardisation activities and the activities of the notified body coordination group established under the relevant EU legislation and apply as general guidance the administrative decisions and documents produced by that group.

(1) Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93.