CHAPTER II F46UAS intended to be operated in the ‘ open ’ category ..., accessories kits bearing a class identification label and remote identification add-ons

SECTION 4 F1Approval of conformity assessment bodies

F2Article 18Approval

(1)

F3A market surveillance may approve bodies to carry out third-party conformity assessment tasks under this Regulation.

(2)

F4A market surveillance authority may not approve a body to carry out third-party conformity assessment tasks under paragraph 1 unless satisfied the body meets the criteria specified in Article 22.

(3)

Where a body demonstrates its conformity with applicable designated standards or parts thereof, it shall be presumed to meet the requirements set out in Article 22 insofar as the applicable designated standards cover those requirements.

(4)

The Secretary of State must—

(a)

assign an approved body identification number to each approved body;

(b)

compile and maintain a register of approved bodies containing in relation to each body—

(i)

the approved body identification number,

(ii)

details of the activities for which the body is approved, and

(iii)

any restrictions on the activities for which the body is approved.

(5)

The register referred to in F5paragraph 4 must be made publicly available.

F6Article 19Notifying authorities

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F7Article 20Requirements relating to notifying authorities

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F8Article 21Information obligation on notifying authorities

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Article 22Requirements relating to F9approved bodies

1.

For the purposes of F10approval, a conformity assessment body shall meet the requirements laid down in paragraphs 2 to 11.

F112.

A conformity assessment body shall have legal personality and shall be established in—

(a)

the United Kingdom; or

(b)

the territory of a party to the CPTPP.

F122A.

In paragraph (2) “the CPTPP” has the meaning set out in section 1 of the Trade (Comprehensive and Progressive Agreement for Trans-Pacific Partnership) Act 2024.

3.

A conformity assessment body shall be a third-party body independent of the organisation 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.

4.

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 that is 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 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.

5.

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.

6.

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 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 product in relation to 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 in accordance with 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 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 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.

7.

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 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 requirements, of the applicable F13designated standards and of the relevant provisions of applicable enactments;

(d)

the ability to draw up F14type examination certificates or quality system approvals, 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 personnel responsible for carrying out the conformity assessment tasks shall be guaranteed.

The remuneration of the top-level management and of 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.

9.

Conformity assessment bodies shall take out liability insurance F15....

10.

The personnel of a conformity assessment body shall observe professional secrecy with regard to all information obtained in carrying out their tasks under Parts 8 and 9 of the Annex F16... except in relation to F17the Secretary of State or the market surveillance authorities. Proprietary rights shall be protected.

11.

Conformity assessment bodies shall participate in, or ensure that their personnel responsible for carrying out the conformity assessment tasks are informed of, the relevant F18standardisation activities and the regulatory activities in the area of UAS and frequency planningF19....

F20Article 23Presumption of conformity of notified bodies

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Article 24Subsidiaries of and subcontracting by F21approved bodies

1.

Where F22an approved body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements set out in Article 22 and shall inform F23a market surveillance authority accordingly.

2.

F24Approved bodies shall take full responsibility for the tasks performed by subcontractors or subsidiaries, wherever these are established.

3.

Activities may be subcontracted or carried out by a subsidiary only with the agreement of the client.

4.

F25Approved bodies shall keep at the disposal of F23a market surveillance authority the relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary and the work carried out by them under Parts 8 and 9 of the Annex.

Article 25Application for F26approval

1.

A conformity assessment body shall submit an application for F27approval to F28a market surveillance authority.

2.

The application for F29approval shall be accompanied by a description of the conformity assessment activities, the conformity assessment module or modules, and the product for which that body claims to be competent, as well as by an accreditation certificate issued by F30the United Kingdom Accreditation Service attesting that the conformity assessment body fulfils the requirements laid down in Article 22.

F31Article 26Notification procedure

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F32Article 27Identification numbers and lists of notified bodies

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Article 28Changes to F33approvals

1.

Where F34a market surveillance authority has ascertained or has been informed that F35an approved body no longer meets the requirements laid down in Article 22, or that it fails to fulfil its obligations, the F36market surveillance authority shall restrict, suspend or withdraw the F37approval as appropriate, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. F38...

2.

In the event of restriction, suspension or withdrawal of the F39approval, or where the F40approved body has ceased its activity, F41a market surveillance authority shall take appropriate steps to ensure that the files of that body are either processed by another F40approved body or kept available. F42...

F43Article 29Challenge of the competence of notified bodies

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Article 30Operational obligations of F44approved bodies

1.

F45Approved bodies shall carry out conformity assessments in accordance with the conformity assessment procedures provided in Parts 8 and 9 of the Annex.

2.

Conformity assessments shall be carried out in a proportionate manner, avoiding unnecessary burdens for economic operators. Conformity assessment bodies shall perform their activities taking due 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.

In doing so, they shall nevertheless respect the degree of rigour and the level of protection required for the compliance of the UA or UAS with this Chapter.

F463.

Where F47an approved body finds that the requirements set out in Parts 1 to 6, 16 and 17 of the Annex or in corresponding F48designated standards or other technical specifications have not been met by a manufacturer, it shall require the manufacturer to take appropriate corrective measures and shall not issue F49a type examination certificate or a quality system approval.

4.

Where, in the course of the monitoring of conformity following the F50issue of a type examination certificate or a quality system approval, F51an approved body finds that a product no longer complies, it shall require the manufacturer to take appropriate corrective measures and shall suspend or F52withdraw the type examination certificate or the quality system approval if necessary.

5.

Where corrective measures are not taken or do not have the required effect, the F53approved body shall restrict, suspend or withdraw any F54type examination certificates or quality system approvals, as appropriate.

Article 31Appeal against decisions of F55approved bodies

F56Approved bodies shall ensure that a transparent and accessible appeal procedure against their decisions is available.

Article 32Information obligation on F57approved bodies

1.

F58Approved bodies shall inform F59a market surveillance authority of the following:

(a)

any refusal, restriction, suspension or withdrawal of F60a type examination certificate or a quality system approval in accordance with the requirements of Parts 8 and 9 of the Annex;

(b)

any circumstances affecting the scope of, or conditions for, F61approval;

F62(c)

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(d)

on request, conformity assessment activities performed within the scope of their F63approval and any other activity performed, including cross-border activities and subcontracting.

2.

F64Approved bodies shall, in accordance with the requirements of Parts 8 and 9 of the Annex, provide the other bodies F64approved under this Chapter carrying out similar conformity assessment activities covering the same categories of UA or UAS with the relevant information on issues relating to negative and, on request, positive conformity assessment results.

3.

F65Approved bodies shall fulfil information obligations under Parts 8 and 9 of the Annex.

F66Article 33Exchange of experience

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F67Article 34Coordination of notified bodies

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