Commission Delegated Regulation (EU) 2019/945Dangos y teitl llawn

SECTION 4 U.K. [F1 Approval] of conformity assessment bodies

[F2 Article 18 U.K. Approval

(1) [F3 A market surveillance] may approve bodies to carry out third-party conformity assessment tasks under this Regulation.

(2) [F4 A 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 [F5 paragraph 4] must be made publicly available.]

Textual Amendments

F2 Art. 18 substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 22

F3 Words in Art. 18(1) substituted (1.1.2026) by The Unmanned Aircraft (Amendment) Regulations 2025 (S.I. 2025/1106), regs. 1(2), 6(4)(a)

F4 Words in Art. 18(2) substituted (1.1.2026) by The Unmanned Aircraft (Amendment) Regulations 2025 (S.I. 2025/1106), regs. 1(2), 6(4)(a)

F5 Words in Art. 18(5) substituted (1.1.2026) by The Unmanned Aircraft (Amendment) Regulations 2025 (S.I. 2025/1106), regs. 1(2), 6(4)(b)

F6 Article 19 U.K. Notifying authorities

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Textual Amendments

F6 Art. 19 omitted (31.12.2020) by virtue of The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 23

F7 Article 20 U.K. Requirements relating to notifying authorities

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Textual Amendments

F7 Art. 20 omitted (31.12.2020) by virtue of The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 23

F8 Article 21 U.K. Information obligation on notifying authorities

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Textual Amendments

F8 Art. 21 omitted (31.12.2020) by virtue of The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 23

Article 22 U.K. Requirements relating to [F9 approved] bodies

1. For the purposes of [F10 approval], a conformity assessment body shall meet the requirements laid down in paragraphs 2 to 11.

[F11 2. 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.]

[F12 2A. 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 [F13 designated standards and of the relevant provisions of applicable enactments];

(d) the ability to draw up [F14 type] 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 [F17 the 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 [F18 standardisation activities and the regulatory activities] in the area of UAS and frequency planningF19 ....

Textual Amendments

F9 Word in Art. 22 heading substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 24(2)

F10 Word in Art. 22(1) substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 24(3)

F11 Art. 22(2) substituted (coming into force in accordance with reg. 1(2) of the amending S.I.) by The Treatment of Conformity Assessment Bodies (Comprehensive and Progressive Agreement for Trans-Pacific Partnership) Regulations 2024 (S.I. 2024/504), reg. 20(a)

F12 Art. 22(2A) inserted (coming into force in accordance with reg. 1(2) of the amending S.I.) by The Treatment of Conformity Assessment Bodies (Comprehensive and Progressive Agreement for Trans-Pacific Partnership) Regulations 2024 (S.I. 2024/504), reg. 20(b)

F13 Words in Art. 22(7)(c) substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 24(5)(a)

F14 Word in Art. 22(7)(d) substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 24(5)(b)

F15 Words in Art. 22(9) omitted (31.12.2020) by virtue of The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 24(6)

F16 Words in Art. 22(10) omitted (31.12.2020) by virtue of The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 24(7)(a)

F17 Words in Art. 22(10) substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 24(7)(b)

F18 Words in Art. 22(11) substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 24(8)(a)

F19 Words in Art. 22(11) omitted (31.12.2020) by virtue of The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 24(8)(b)

F20 Article 23 U.K. Presumption of conformity of notified bodies

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Textual Amendments

F20 Art. 23 omitted (31.12.2020) by virtue of The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 25

Article 24 U.K. Subsidiaries of and subcontracting by [F21 approved] bodies

1. Where [F22 an 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 [F23 a market surveillance authority] accordingly.

2. [F24 Approved] 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. [F25 Approved] bodies shall keep at the disposal of [F23 a 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.

Textual Amendments

F21 Word in Art. 24 heading substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 26(2)

F22 Words in Art. 24(1) substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 26(3)(a)

F23 Words in Art. 24 substituted (1.1.2026) by The Unmanned Aircraft (Amendment) Regulations 2025 (S.I. 2025/1106), regs. 1(2), 6(5)

F24 Word in Art. 24(2) substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 26(4)

F25 Word in Art. 24(4) substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 26(5)(a)

Article 25 U.K. Application for [F26 approval]

1. A conformity assessment body shall submit an application for [F27 approval] to [F28 a market surveillance authority].

2. The application for [F29 approval] 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 [F30 the United Kingdom Accreditation Service] attesting that the conformity assessment body fulfils the requirements laid down in Article 22.

Textual Amendments

F26 Word in Art. 25 heading substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 27(2)

F27 Word in Art. 25(1) substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 27(3)(a)

F28 Words in Art. 25(1) substituted (1.1.2026) by The Unmanned Aircraft (Amendment) Regulations 2025 (S.I. 2025/1106), regs. 1(2), 6(6)

F29 Word in Art. 25(2) substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 27(4)(a)

F30 Words in Art. 25(2) substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 27(4)(b)

F31 Article 26 U.K. Notification procedure

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Textual Amendments

F31 Art. 26 omitted (31.12.2020) by virtue of The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 28

F32 Article 27 U.K. Identification numbers and lists of notified bodies

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Textual Amendments

F32 Art. 27 omitted (31.12.2020) by virtue of The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 28

Article 28 U.K. Changes to [F33 approvals]

1. Where [F34 a market surveillance authority] has ascertained or has been informed that [F35 an approved] body no longer meets the requirements laid down in Article 22, or that it fails to fulfil its obligations, the [F36 market surveillance authority] shall restrict, suspend or withdraw the [F37 approval] 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 [F39 approval], or where the [F40 approved] body has ceased its activity, [F41 a market surveillance authority] shall take appropriate steps to ensure that the files of that body are either processed by another [F40 approved] body or kept available. F42 ...

Textual Amendments

F33 Word in Art. 28 heading substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 29(2)

F34 Words in Art. 28(1) substituted (1.1.2026) by The Unmanned Aircraft (Amendment) Regulations 2025 (S.I. 2025/1106), regs. 1(2), 6(7)(a)(i)

F35 Words in Art. 28(1) substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 29(3)(b)

F36 Words in Art. 28(1) substituted (1.1.2026) by The Unmanned Aircraft (Amendment) Regulations 2025 (S.I. 2025/1106), regs. 1(2), 6(7)(a)(ii)

F37 Word in Art. 28(1) substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 29(3)(d)

F38 Words in Art. 28(1) omitted (31.12.2020) by virtue of The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 29(3)(e)

F39 Word in Art. 28(2) substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 29(4)(a)

F40 Word in Art. 28(2) substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 29(4)(b)

F41 Words in Art. 28(2) substituted (1.1.2026) by The Unmanned Aircraft (Amendment) Regulations 2025 (S.I. 2025/1106), regs. 1(2), 6(7)(b)(i)

F42 Words in Art. 28(2) omitted (1.1.2026) by virtue of The Unmanned Aircraft (Amendment) Regulations 2025 (S.I. 2025/1106), regs. 1(2), 6(7)(b)(ii)

F43 Article 29 U.K. Challenge of the competence of notified bodies

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Textual Amendments

F43 Art. 29 omitted (31.12.2020) by virtue of The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 30

Article 30 U.K. Operational obligations of [F44 approved] bodies

1. [F45 Approved] 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.

[F46 3. Where [F47 an approved] body finds that the requirements set out in Parts 1 to 6, 16 and 17 of the Annex or in corresponding [F48 designated] 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 [F49 a type] examination certificate or a quality system approval.]

4. Where, in the course of the monitoring of conformity following the [F50 issue of a type] examination certificate or a quality system approval, [F51 an approved] body finds that a product no longer complies, it shall require the manufacturer to take appropriate corrective measures and shall suspend or [F52 withdraw 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 [F53 approved] body shall restrict, suspend or withdraw any [F54 type] examination certificates or quality system approvals, as appropriate.

Textual Amendments

F44 Word in Art. 30 heading substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 31(2)

F45 Word in Art. 30(1) substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 31(3)

F46 Substituted by Commission Delegated Regulation (EU) 2020/1058 of 27 April 2020 amending Delegated Regulation (EU) 2019/945 as regards the introduction of two new unmanned aircraft systems classes.

F47 Words in Art. 30(3) substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 31(4)(a)

F48 Word in Art. 30(3) substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 31(4)(b)

F49 Words in Art. 30(3) substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 31(4)(c)

F50 Words in Art. 30(4) substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 31(5)(a)

F51 Words in Art. 30(4) substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 31(5)(b)

F52 Words in Art. 30(4) substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 31(5)(c)

F53 Word in Art. 30(5) substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 31(6)(a)

F54 Word in Art. 30(5) substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 31(6)(b)

Article 31 U.K. Appeal against decisions of [F55 approved] bodies

[F56 Approved] bodies shall ensure that a transparent and accessible appeal procedure against their decisions is available.

Textual Amendments

F55 Word in Art. 31 heading substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 32(2)

F56 Word in Art. 31 substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 32(3)

Article 32 U.K. Information obligation on [F57 approved] bodies

1. [F58 Approved] bodies shall inform [F59 a market surveillance authority] of the following:

(a) any refusal, restriction, suspension or withdrawal of [F60 a 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, [F61 approval];

F62 (c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(d) on request, conformity assessment activities performed within the scope of their [F63 approval] and any other activity performed, including cross-border activities and subcontracting.

2. [F64 Approved] bodies shall, in accordance with the requirements of Parts 8 and 9 of the Annex, provide the other bodies [F64 approved] 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. [F65 Approved] bodies shall fulfil information obligations under Parts 8 and 9 of the Annex.

Textual Amendments

F57 Word in Art. 32 heading substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 33(2)

F58 Word in Art. 32(1) substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 33(3)(a)

F59 Words in Art. 32(1) substituted (1.1.2026) by The Unmanned Aircraft (Amendment) Regulations 2025 (S.I. 2025/1106), regs. 1(2), 6(8)(a)

F60 Words in Art. 32(1)(a) substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 33(3)(c)

F61 Word in Art. 32(1)(b) substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 33(3)(d)

F62 Art. 32(1)(c) omitted (1.1.2026) by virtue of The Unmanned Aircraft (Amendment) Regulations 2025 (S.I. 2025/1106), regs. 1(2), 6(8)(b)

F63 Word in Art. 32(1)(d) substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 33(3)(d)

F64 Word in Art. 32(2) substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 33(4)

F65 Word in Art. 32(3) substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 33(4)

F66 Article 33 U.K. Exchange of experience

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Textual Amendments

F66 Art. 33 omitted (31.12.2020) by virtue of The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 34

F67 Article 34 U.K. Coordination of notified bodies

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Textual Amendments

F67 Art. 34 omitted (31.12.2020) by virtue of The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 35

Textual Amendments

F1 Word in Ch. 2 s. 4 heading substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 21