Commission Delegated Regulation (EU) 2019/945Show full title

[F1 PART 8 U.K. Conformity assessment Modules B and C – [F2 Type] examination and conformity to type based on internal production control

When reference is made to this Part, the conformity assessment procedure shall follow Modules B ([F3 type] examination) and C (Conformity to type based on internal production control) of this Part.

Textual Amendments

F3 Word in Annex Pt. 8 substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 53(3)

Module B [F4 Type] examination U.K.

1. [F5 Type] examination is the part of a conformity assessment procedure in which [F6 an approved] body examines the technical design of the product and verifies and attests that the technical design of the product meets the applicable requirements set out in Parts 1 to 6, 16 and 17. U.K.

Textual Amendments

F5 Word in Annex Pt. 8 Module B point 1 substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 53(4)(b)(i)

F6 Words in Annex Pt. 8 Module B point 1 substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 53(4)(b)(ii)

2. [F7 Type] examination shall be carried out by an assessment of the adequacy of the technical design of the product through examination of the technical documentation and supporting evidence referred to in point 3, plus examination of specimens, representative of the production envisaged, of one or more critical parts of the product (combination of production type and design type). U.K.

Textual Amendments

F7 Word in Annex Pt. 8 Module B point 2 substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 53(4)(c)

3. The manufacturer shall lodge an application for [F8 type] examination with a single [F9 approved] body of his choice. U.K.

Textual Amendments

F8 Word in Annex Pt. 8 Module B point 3 substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 53(4)(d)(i)

F9 Word in Annex Pt. 8 Module B point 3 substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 53(4)(d)(ii)

The application shall include:

(1)

the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well;

(2)

a written declaration that the same application has not been lodged with any other [F10 approved] body;

(3)

the technical documentation; the technical documentation shall make it possible to assess the product’s conformity with the applicable requirements of this Regulation and shall include an adequate analysis and assessment of the risk(s); the technical documentation shall contain, wherever applicable, the elements set out in Article 17 of this Regulation;

(4)

the specimens representative of the production envisaged; the [F11 approved] body may request further specimens if needed for carrying out the test programme;

(5)

the supporting evidence for the adequacy of the technical design solution; this supporting evidence shall mention any documents that have been used, in particular where the relevant [F12 designated] standards and/or technical specifications have not been applied or have not been applied in full; the supporting evidence shall include, where necessary, the results of tests carried out in accordance with other relevant technical specifications by the appropriate laboratory of the manufacturer or by another testing laboratory on his behalf and under his responsibility.

Textual Amendments

F10 Word in Annex Pt. 8 Module B point 3(2) substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 53(4)(d)(iii)

F11 Word in Annex Pt. 8 Module B point 3(4) substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 53(4)(d)(iii)

F12 Word in Annex Pt. 8 Module B point 3(5) substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 53(4)(d)(iv)

4. The [F13 approved] body shall: U.K.

Textual Amendments

F13 Word in Annex Pt. 8 Module B point 4 substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 53(4)(e)(i)

For the product:

(1)

examine the technical documentation and supporting evidence to assess the adequacy of the product’s technical design.

For the specimen(s):

(2)

verify that the specimen(s) has (have) been manufactured in conformity with the technical documentation, and identify the elements which have been designed in accordance with the applicable provisions of the relevant [F14 designated] standards and/or technical specifications, as well as the elements which have been designed without applying the relevant provisions of those standards;

(3)

carry out appropriate examinations and tests, or have them carried out, to check whether, where the manufacturer has chosen to apply the solutions in the relevant [F15 designated] standards and/or technical specifications, these have been applied correctly;

(4)

carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the relevant [F16 designated] standards and/or technical specifications have not been applied, the solutions adopted by the manufacturer meet the corresponding essential requirements of the legislative instrument;

(5)

agree with the manufacturer on a location where the examinations and tests will be carried out.

Textual Amendments

F14 Word in Annex Pt. 8 Module B point 4(2) substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 53(4)(e)(ii)

F15 Word in Annex Pt. 8 Module B point 4(3) substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 53(4)(e)(ii)

F16 Word in Annex Pt. 8 Module B point 4(4) substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 53(4)(e)(ii)

5. The [F17 approved] body shall draw up an evaluation report that records the activities undertaken in accordance with point 4 and their outcomes. Without prejudice to its obligations as provided in point 8, the [F17 approved] body shall release the content of this report, in full or in part, only with the agreement of the manufacturer. U.K.

Textual Amendments

F17 Word in Annex Pt. 8 Module B point 5 substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 53(4)(f)

6. Where the type meets the requirements of this Regulation, the [F18 approved] body shall issue an [F19 type] examination certificate to the manufacturer. This certificate shall contain the name and address of the manufacturer, the conclusions of the examination, the relevant aspects of the requirements covered by the examination, the conditions (if any) for its validity, and the data necessary for the identification of the approved type. The certificate may have one or more annexes attached to it. U.K.

Textual Amendments

F18 Word in Annex Pt. 8 Module B point 6 substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 53(4)(g)(i)(aa)

F19 Word in Annex Pt. 8 Module B point 6 substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 53(4)(g)(i)(bb)

The F20 ... certificate and its annexes shall contain all relevant information to allow the conformity of manufactured products with the examined type to be evaluated and to allow for in service control.

Textual Amendments

F20 Word in Annex Pt. 8 Module B point 6 omitted (31.12.2020) by virtue of The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 53(4)(g)(ii)

Where the type does not satisfy the applicable requirements of this Regulation, the notified body shall refuse to issue an [F21 type] examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.

Textual Amendments

F21 Word in Annex Pt. 8 Module B point 6 substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 53(4)(g)(iii)

7. The [F22 approved] body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicates that the approved type may no longer comply with the applicable requirements of this Regulation, and shall determine whether such changes require further investigation. If so, the [F22 approved] body shall inform the manufacturer accordingly. U.K.

Textual Amendments

F22 Word in Annex Pt. 8 Module B point 7 substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 53(4)(h)(i)

The manufacturer shall inform the [F23 approved] body that holds the technical documentation relating to the [F24 type] examination certificate of all modifications to the approved type that may affect the product’s conformity with the essential requirements of this Regulation or the conditions for the certificate’s validity. Such modifications shall require additional approval and attached to the original [F24 type] examination certificate.

Textual Amendments

F23 Word in Annex Pt. 8 Module B point 7 substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 53(4)(h)(ii)(aa)

F24 Word in Annex Pt. 8 Module B point 7 substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 53(4)(h)(ii)(bb)

8. Each [F25 approved] body shall inform [F26 the Secretary of State] concerning the [F27 type] examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to [F26 the Secretary of State] the list of certificates and/or any additions thereto refused, suspended or otherwise restricted. U.K.

Textual Amendments

F25 Word in Annex Pt. 8 Module B point 8 substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 53(4)(i)(i)(aa)

F26 Words in Annex Pt. 8 Module B point 8 substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 53(4)(i)(i)(bb)

F27 Word in Annex Pt. 8 Module B point 8 substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 53(4)(i)(i)(cc)

Each [F28 approved] body shall inform the other [F28 approved] bodies concerning the [F29 type] examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning the certificates and/or additions thereto which it has issued.

Textual Amendments

F28 Word in Annex Pt. 8 Module B point 8 substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 53(4)(i)(ii)(aa)

F29 Word in Annex Pt. 8 Module B point 8 substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 53(4)(i)(ii)(bb)

[F30 The Secretary of State and the other approved bodies] may, on request, obtain a copy of the [F31 type] examination certificates and/or additions thereto. On a reasoned request, [F32 the Secretary of State] may obtain a copy of the technical documentation and the results of the examinations carried out by the [F33 approved] body.

Textual Amendments

F30 Words in Annex Pt. 8 Module B point 8 substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 53(4)(i)(iii)(aa)

F31 Word in Annex Pt. 8 Module B point 8 substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 53(4)(i)(iii)(bb)

F32 Words in Annex Pt. 8 Module B point 8 substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 53(4)(i)(iii)(cc)

F33 Word in Annex Pt. 8 Module B point 8 substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 53(4)(i)(iii)(dd)

The [F34 approved] body shall keep a copy of the [F35 type] examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer for 10 years after the product has been assessed or until the validity of the certificate expires.

Textual Amendments

F34 Word in Annex Pt. 8 Module B point 8 substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 53(4)(i)(iv)(aa)

F35 Word in Annex Pt. 8 Module B point 8 substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 53(4)(i)(iv)(bb)

9. The manufacturer shall keep a copy of the [F36 type] examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the product has been placed on the market. U.K.

Textual Amendments

F36 Word in Annex Pt. 8 Module B point 9 substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 53(4)(j)

10. The manufacturer’s authorised representative may lodge the application referred to in point 3 and fulfil the obligations set out in points 7 and 9, provided that they are specified in the mandate. U.K.

Textual Amendments

F4 Word in Annex Pt. 8 Module B heading substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 53(4)(a)

Module C Conformity to type based on internal production control U.K.

1. Conformity to type based on internal production control is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 3, and ensures and declares that the products concerned are in conformity with the type described in the [F37 type] examination certificate and satisfy the applicable requirements of this Regulation. U.K.

Textual Amendments

F37 Word in Annex Pt. 8 Module C point 1 substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 53(5)(a)

2. Manufacturing U.K.

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured product with the approved type described in the [F38 type] examination certificate and with the applicable requirements set out in Parts 1 to 6, 16 and 17.

Textual Amendments

F38 Word in Annex Pt. 8 Module C point 2 substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 53(5)(a)

3. [F39 UK marking and declaration] of conformity U.K.

(1)

The manufacturer shall affix the [F40 UK] marking and, when relevant, the UA class identification label in accordance with Articles 15 and 16 of this Regulation to each product that is in conformity with the type described in the [F41 type] examination certificate and satisfies the applicable requirements set out in Parts 1 to 6, 16 and 17.

(2)

The manufacturer shall draw up a written F42 ... declaration of conformity for each product type and keep it at the disposal of the national authorities for 10 years after the product has been placed on the market. The F42 ... declaration of conformity shall clearly identify the product type for which it has been drawn up.

A copy of the F42 ... declaration of conformity shall be made available to the relevant authorities upon request.

Textual Amendments

F40 Word in Annex Pt. 8 Module C point 3(1) substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 53(5)(b)(ii)(aa)

F41 Word in Annex Pt. 8 Module C point 3(1) substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 53(5)(b)(ii)(bb)

F42 Word in Annex Pt. 8 Module C point 3(2) omitted (31.12.2020) by virtue of The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 53(5)(b)(iii)

Textual Amendments

F39 Words in Annex Pt. 8 Module C point 3 heading substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 53(5)(b)(i)

4. Authorised representative U.K.

The manufacturer’s obligations set out in point 3 may be fulfilled by their authorised representative, on their behalf and under their responsibility, provided that this is specified in the mandate.]

Textual Amendments

F1 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.

F2 Word in Annex Pt. 8 heading substituted (31.12.2020) by The Unmanned Aircraft (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1593), regs. 1(2), 53(2)