CHAPTER IIU.K.F1 [F2UAS intended to be operated in the ‘ open ’ category ..., accessories kits bearing a class identification label and remote identification add-ons]

SECTION 4U.K. [F3Approval] of conformity assessment bodies

[F4Article 18U.K.Approval

(1)[F5A market surveillance] may approve bodies to carry out third-party conformity assessment tasks under this Regulation.

(2)[F6A 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 [F7paragraph 4] must be made publicly available.]

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F8Article 19U.K.Notifying authorities

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F9Article 20U.K.Requirements relating to notifying authorities

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F10Article 21U.K.Information obligation on notifying authorities

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Article 22U.K.Requirements relating to [F11approved] bodies

1.For the purposes of [F12approval], a conformity assessment body shall meet the requirements laid down in paragraphs 2 to 11.

[F132.A conformity assessment body shall have legal personality and shall be established in—

(athe United Kingdom; or

(bthe territory of a party to the CPTPP.]

[F142A.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 [F15designated standards and of the relevant provisions of applicable enactments];

(d)the ability to draw up [F16type] 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 F17....

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 F18... except in relation to [F19the 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 [F20standardisation activities and the regulatory activities] in the area of UAS and frequency planningF21....

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F22Article 23U.K.Presumption of conformity of notified bodies

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Article 24U.K.Subsidiaries of and subcontracting by [F23approved] bodies

1.Where [F24an 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 [F25a market surveillance authority] accordingly.

2.[F26Approved] 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.[F27Approved] bodies shall keep at the disposal of [F25a 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.

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Article 25U.K.Application for [F28approval]

1.A conformity assessment body shall submit an application for [F29approval] to [F30a market surveillance authority].

2.The application for [F31approval] 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 [F32the United Kingdom Accreditation Service] attesting that the conformity assessment body fulfils the requirements laid down in Article 22.

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F33Article 26U.K.Notification procedure

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F34Article 27U.K.Identification numbers and lists of notified bodies

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Article 28U.K.Changes to [F35approvals]

1.Where [F36a market surveillance authority] has ascertained or has been informed that [F37an approved] body no longer meets the requirements laid down in Article 22, or that it fails to fulfil its obligations, the [F38market surveillance authority] shall restrict, suspend or withdraw the [F39approval] as appropriate, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. F40...

2.In the event of restriction, suspension or withdrawal of the [F41approval], or where the [F42approved] body has ceased its activity, [F43a market surveillance authority] shall take appropriate steps to ensure that the files of that body are either processed by another [F42approved] body or kept available. F44...

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F45Article 29U.K.Challenge of the competence of notified bodies

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Article 30U.K.Operational obligations of [F46approved] bodies

1.[F47Approved] 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.

[F23.Where [F48an approved] body finds that the requirements set out in Parts 1 to 6, 16 and 17 of the Annex or in corresponding [F49designated] 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 [F50a type] examination certificate or a quality system approval.]

4.Where, in the course of the monitoring of conformity following the [F51issue of a type] examination certificate or a quality system approval, [F52an approved] body finds that a product no longer complies, it shall require the manufacturer to take appropriate corrective measures and shall suspend or [F53withdraw 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 [F54approved] body shall restrict, suspend or withdraw any [F55type] examination certificates or quality system approvals, as appropriate.

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Article 31U.K.Appeal against decisions of [F56approved] bodies

[F57Approved] bodies shall ensure that a transparent and accessible appeal procedure against their decisions is available.

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Article 32U.K.Information obligation on [F58approved] bodies

1.[F59Approved] bodies shall inform [F60a market surveillance authority] of the following:

(a)any refusal, restriction, suspension or withdrawal of [F61a 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, [F62approval];

F63(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(d)on request, conformity assessment activities performed within the scope of their [F64approval] and any other activity performed, including cross-border activities and subcontracting.

2.[F65Approved] bodies shall, in accordance with the requirements of Parts 8 and 9 of the Annex, provide the other bodies [F65approved] 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.[F66Approved] bodies shall fulfil information obligations under Parts 8 and 9 of the Annex.

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F67Article 33U.K.Exchange of experience

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F68Article 34U.K.Coordination of notified bodies

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