Regulation (EU) 2016/424 of the European Parliament and of the CouncilShow full title

CHAPTER IV U.K. NOTIFICATION OF CONFORMITY ASSESSMENT BODIES

[F1 Article 22 U.K. Approval

1. The Secretary of State may approve bodies to carry out third-party conformity assessment tasks under this Regulation.

2. 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.

3. The register referred to in paragraph 2 must be made publicly available.]

Textual Amendments

F1 Art. 22 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 31; 2020 c. 1, Sch. 5 para. 1(1)

F2 Article 23 U.K. Notifying authorities

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Textual Amendments

F2 Arts. 23-25 omitted (31.12.2020) by virtue of The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 32; 2020 c. 1, Sch. 5 para. 1(1)

F2 Article 24 U.K. Requirements relating to notifying authorities

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Textual Amendments

F2 Arts. 23-25 omitted (31.12.2020) by virtue of The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 32; 2020 c. 1, Sch. 5 para. 1(1)

F2 Article 25 U.K. Information obligation on notifying authorities

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Textual Amendments

F2 Arts. 23-25 omitted (31.12.2020) by virtue of The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 32; 2020 c. 1, Sch. 5 para. 1(1)

Article 26 U.K. Requirements relating to [F3 approved] bodies

1. For the purposes of [F4 approval], a conformity assessment body shall meet the requirements laid down in [F5 paragraphs 3 to 10].

F6 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3. A conformity assessment body shall be a third-party body independent of the organisation or the subsystem or the safety component 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 subsystems or safety components which it assesses, may, on the 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 subsystems or the safety components which they assess, nor the representative of any of those parties. This shall not preclude the use of assessed subsystems or safety components that are necessary for the operations of the conformity assessment body or the use of such subsystems or safety components 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, marketing, installation, use or maintenance of those subsystems or safety components, 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 Annexes III to VII and 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 subsystems or safety components 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 subsystem or safety component technology 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 essential requirements set out in Annex II, of the applicable [F7 designated standards and of the relevant provisions of this Regulation and of the Cableway Installations Regulations 2018];

(d) the ability to draw up certificates, 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, nor on the results of those assessments.

9. Conformity assessment bodies shall take out liability insurance F8 ....

10. The personnel of a conformity assessment body shall observe professional secrecy with regard to all information obtained in carrying out their tasks under Annexes III to VII F9 ..., except in relation to the [F10 Secretary of State or the Executive]. Proprietary rights shall be protected.

F11 11. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F3 Word in Art. 26 heading substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 33(a); 2020 c. 1, Sch. 5 para. 1(1)

F4 Word in Art. 26(1) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 33(b)(i); 2020 c. 1, Sch. 5 para. 1(1)

F5 Words in Art. 26(1) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 33(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F6 Art. 26(2) omitted (31.12.2020) by virtue of The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 33(c); 2020 c. 1, Sch. 5 para. 1(1)

F7 Words in Art. 26(7)(c) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 33(d); 2020 c. 1, Sch. 5 para. 1(1)

F8 Words in Art. 26(9) omitted (31.12.2020) by virtue of The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 33(e); 2020 c. 1, Sch. 5 para. 1(1)

F9 Words in Art. 26(10) omitted (31.12.2020) by virtue of The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 33(f)(i); 2020 c. 1, Sch. 5 para. 1(1)

F10 Words in Art. 26(10) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 33(f)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F11 Art. 26(11) omitted (31.12.2020) by virtue of The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 33(g); 2020 c. 1, Sch. 5 para. 1(1)

Article 27 U.K. Presumption of conformity of notified bodies

[F12 1.] Where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union, it shall be presumed to comply with the requirements set out in Article 26 in so far as the applicable harmonised standards cover those requirements.

[F13 2. In paragraph 1, expressions used are to be given the same meaning as in the EU Regulation.]

Textual Amendments

F12 Art. 27 renumbered as Art. 27(1) (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 34(a); 2020 c. 1, Sch. 5 para. 1(1)

F13 Art. 27(2) inserted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 34(b); 2020 c. 1, Sch. 5 para. 1(1)

Article 28 U.K. Subsidiaries of and subcontracting by [F14 approved] bodies

1. Where [F15 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 26 and shall inform the [F16 Secretary of State] accordingly.

2. [F17 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. [F18 Approved] bodies shall keep at the disposal of the [F19 Secretary of State] the relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary and the work carried out by them under Annexes III to VII.

Textual Amendments

F14 Word in Art. 28 heading substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 35(a); 2020 c. 1, Sch. 5 para. 1(1)

F15 Words in Art. 28(1) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 35(b)(i); 2020 c. 1, Sch. 5 para. 1(1)

F16 Words in Art. 28(1) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 35(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F17 Word in Art. 28(2) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 35(c); 2020 c. 1, Sch. 5 para. 1(1)

F18 Word in Art. 28(4) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 35(d)(i); 2020 c. 1, Sch. 5 para. 1(1)

F19 Words in Art. 28(4) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 35(d)(ii); 2020 c. 1, Sch. 5 para. 1(1)

Article 29 U.K. Application for [F20 approval]

1. A conformity assessment body shall submit an application for [F21 approval] to the [F22 Secretary of State].

2. The application for notification shall be accompanied by a description of the conformity assessment activities, the conformity assessment module or modules and the subsystem/safety component or subsystems/safety components for which that body claims to be competent, as well as by an accreditation certificate, where one exists, issued by [F23 the United Kingdom Accreditation Service] attesting that the conformity assessment body fulfils the requirements laid down in Article 26.

3. Where the conformity assessment body concerned cannot provide an accreditation certificate, it shall provide the notifying authority with all the documentary evidence necessary for the verification, recognition and regular monitoring of its compliance with the requirements laid down in Article 26.

Textual Amendments

F20 Word in Art. 29 heading substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 36(a); 2020 c. 1, Sch. 5 para. 1(1)

F21 Word in Art. 29(1) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 36(a); 2020 c. 1, Sch. 5 para. 1(1)

F22 Words in Art. 29(1) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 36(b); 2020 c. 1, Sch. 5 para. 1(1)

F23 Words in Art. 29(2) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 36(c); 2020 c. 1, Sch. 5 para. 1(1)

F24 Article 30 U.K. Notification procedure

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Textual Amendments

F24 Art. 30 omitted (31.12.2020) by virtue of The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 37; 2020 c. 1, Sch. 5 para. 1(1)

F25 Article 31 U.K. Identification numbers and lists of notified bodies

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Textual Amendments

F25 Art. 31 omitted (31.12.2020) by virtue of The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 37; 2020 c. 1, Sch. 5 para. 1(1)

Article 32 U.K. Changes to [F26 approvals]

1. Where [F27 the Secretary of State] has ascertained or has been informed that [F28 an approved] body no longer meets the requirements laid down in Article 26 or that it is failing to fulfil its obligations, [F29 the Secretary of State] shall restrict, suspend or withdraw the [F30 approval], as appropriate, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. F31 ...

2. In the event of restriction, suspension or withdrawal of notification, or where [F32 the approved] body has ceased its activity, the [F33 Secretary of State] shall take appropriate steps to ensure that the files of that body are either processed by [F34 another approved] body or kept available for the [F35 Secretary of State and the Executive] at their request.

Textual Amendments

F26 Word in Art. 32 heading substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 38(a); 2020 c. 1, Sch. 5 para. 1(1)

F27 Words in Art. 32(1) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 38(b)(i); 2020 c. 1, Sch. 5 para. 1(1)

F28 Words in Art. 32(1) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 38(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F29 Words in Art. 32(1) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 38(b)(iii); 2020 c. 1, Sch. 5 para. 1(1)

F30 Word in Art. 32(1) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 38(b)(iv); 2020 c. 1, Sch. 5 para. 1(1)

F31 Words in Art. 32(1) omitted (31.12.2020) by virtue of The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 38(b)(v); 2020 c. 1, Sch. 5 para. 1(1)

F32 Words in Art. 32(2) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 38(c)(i); 2020 c. 1, Sch. 5 para. 1(1)

F33 Words in Art. 32(2) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 38(c)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F34 Words in Art. 32(2) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 38(c)(iii); 2020 c. 1, Sch. 5 para. 1(1)

F35 Words in Art. 32(2) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 38(c)(iv); 2020 c. 1, Sch. 5 para. 1(1)

F36 Article 33 U.K. Challenge of the competence of notified bodies

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Textual Amendments

F36 Art. 33 omitted (31.12.2020) by virtue of The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 39; 2020 c. 1, Sch. 5 para. 1(1)

Article 34 U.K. Operational obligations of [F37 approved bodies]

1. [F38 Approved bodies] shall carry out conformity assessments in accordance with the conformity assessment procedures provided for in Annexes III to VII.

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 subsystem or safety component technology in question and the mass or serial nature of the production process.

In so doing, they shall nevertheless respect the degree of rigour and the level of protection required for the compliance of the subsystem or the safety component with this Regulation.

3. Where [F39 an approved body] finds that the essential requirements set out in Annex II or [F40 corresponding designated standards] or other technical specifications have not been met by a manufacturer, it shall require that manufacturer to take appropriate corrective measures and shall not issue a certificate or approval decision.

4. Where, in the course of the monitoring of conformity following the issue of a certificate or approval decision, [F41 an approved body] finds that a subsystem or a safety component no longer complies, it shall require the manufacturer to take appropriate corrective measures and shall suspend or withdraw the certificate or the approval decision if necessary.

5. Where corrective measures are not taken or do not have the required effect, [F42 the approved body] shall restrict, suspend or withdraw any certificates or approval decisions, as appropriate.

Textual Amendments

F37 Words in Art. 34 heading substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 40(a); 2020 c. 1, Sch. 5 para. 1(1)

F38 Words in Art. 34(1) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 40(b); 2020 c. 1, Sch. 5 para. 1(1)

F39 Words in Art. 34(3) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 40(c)(i); 2020 c. 1, Sch. 5 para. 1(1)

F40 Words in Art. 34(3) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 40(c)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F41 Words in Art. 34(4) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 40(d); 2020 c. 1, Sch. 5 para. 1(1)

F42 Words in Art. 34(5) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 40(e); 2020 c. 1, Sch. 5 para. 1(1)

Article 35 U.K. Appeal against decisions of [F43 approved] bodies

[F44 Approved] bodies shall ensure that an appeal procedure against their decisions is available.

Textual Amendments

F43 Word in Art. 35 heading substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 41(a); 2020 c. 1, Sch. 5 para. 1(1)

F44 Word in Art. 35 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 41(b); 2020 c. 1, Sch. 5 para. 1(1)

Article 36 U.K. Information obligation on [F45 approved bodies]

1. [F46 Approved bodies] shall inform the [F47 Secretary of State] of the following:

(a) any refusal, restriction, suspension or withdrawal of a certificate or approval decision;

(b) any circumstances affecting the scope of or the conditions for [F48 approval];

(c) any request for information which they have received from [F49 the Executive] regarding conformity assessment activities;

(d) on request, conformity assessment activities performed within the scope of their [F50 approval] and any other activity performed, including cross-border activities and subcontracting.

2. [F51 Approved bodies] shall provide the other bodies [F52 approved under] this Regulation carrying out similar conformity assessment activities covering the same subsystems or safety components with relevant information on issues relating to negative and, on request, positive conformity assessment results.

Textual Amendments

F45 Words in Art. 36 heading substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 42(a); 2020 c. 1, Sch. 5 para. 1(1)

F46 Words in Art. 36(1) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 42(b)(i)(aa); 2020 c. 1, Sch. 5 para. 1(1)

F47 Words in Art. 36(1) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 42(b)(i)(bb); 2020 c. 1, Sch. 5 para. 1(1)

F48 Word in Art. 36(1)(b) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 42(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F49 Words in Art. 36(1)(c) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 42(b)(iii); 2020 c. 1, Sch. 5 para. 1(1)

F50 Word in Art. 36(1)(d) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 42(b)(iv); 2020 c. 1, Sch. 5 para. 1(1)

F51 Words in Art. 36(2) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 42(c)(i); 2020 c. 1, Sch. 5 para. 1(1)

F52 Words in Art. 36(2) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 42(c)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F53 Article 37 U.K. Exchange of experience

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Textual Amendments

F53 Art. 37 omitted (31.12.2020) by virtue of The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 43; 2020 c. 1, Sch. 5 para. 1(1)

F54 Article 38 U.K. Coordination of notified bodies

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Textual Amendments

F54 Art. 38 omitted (31.12.2020) by virtue of The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 43; 2020 c. 1, Sch. 5 para. 1(1)