Article 22 – Requirements relating to notified bodies

 

EU Drone Regulation Guidance

 

Regulation (EU) 2019/945: Requirements for notified bodies

Commission Delegated Regulation (EU) 2019/945 of 12 March 2019 on unmanned aircraft systems and third-country operators of unmanned aircraft systems.

 

SECTION 4

Notification of conformity assessment bodies

 Article 22

Requirements relating to notified bodies

  1. For notification, a conformity assessment body shall meet the requirements laid down in paragraphs 2 to 11.
  2. A conformity assessment body shall be established under the national law of a Member State and have legal personality.
  3. A conformity assessment body shall be a third-party body independent of the organization 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 the product which it assesses may, on condition that its independence and the absence of any conflict of interest are demonstrated, be considered such a body.

 

  1. 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, supplier, installer, purchaser, owner, user, or maintainer of the product which they assess, nor the representative of any of those parties. This shall not preclude the use of the assessed product necessary for the operations of the conformity assessment body or the use of such product 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, or construction, the marketing, installation, use, or maintenance of that product, or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgment or integrity about 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.

  1. Conformity assessment bodies and personnel shall carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical competence in the specific field. They shall be free from all pressures and inducements, mainly financial, which might influence their judgment or the results of their conformity assessment activities, especially as regards persons or groups of persons with interest in the results of those activities.
  2. A conformity assessment body shall be capable of carrying out all the conformity assessment tasks assigned to it by Part 8 or 9 of the Annex about 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 product about which it has been notified, a conformity assessment body shall have at its disposal the necessary:

(a)personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks;
(b)descriptions of procedures by which conformity assessment is carried out, ensuring the transparency and the ability of reproduction of those procedures; it shall have appropriate policies and procedures in place that distinguish between tasks it carries out as a notified body and other activities;
(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 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 appropriately and shall have access to all the required equipment or facilities.

 

  1. The personnel responsible for carrying out conformity assessment tasks shall have the following:
(a)sound technical and vocational training covering all the conformity assessment activities about 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 requirements, of the applicable harmonized standards and the relevant provisions of Union harmonization legislation;
(d)the ability to draw up EU-type examination certificates or quality system approvals, records, and reports demonstrating that assessments have been carried out.
  1. 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.

 

  1. Conformity assessment bodies shall take out liability insurance unless the Member State assumes liability by national law or is directly responsible for the conformity assessment.
  2. The personnel of a conformity assessment body shall observe professional secrecy wit concerning information obtained in carrying out their tasks under Parts 8 and 9 of the Annex or any provision of national law giving effect to them, except in about competent authorities of the Member State in which its activities are carried out. Proprietary rights shall be protected.
  3. Conformity assessment bodies shall participate in or ensure that their personnel responsible for carrying out the conformity assessment tasks are informed of the relevant standardization activities, the regulatory activities in the area of UAS and frequency planning, and the activities of the notified body coordination group established under the applicable Union harmonization legislation. They shall apply, as general guidance, the administrative decisions, and documents produced as a result of the work of that group.
 

Source: EUR – Lex

Key points of European Regulation 2019/945

Notified Body in the conformity assessment.

Instructions and information on CE marking and class label