Regulation (EU) 2016/425 of the European Parliament and of the CouncilDangos y teitl llawn

Article 24 U.K. [F1 Approved body requirements]

1. For the purposes of [F2 approval], a conformity assessment body shall meet the requirements laid down in paragraphs 2 to 11.

[F3 2. A conformity assessment body must have legal personality and must be established in—

(a) the United Kingdom; or

(b) the territory of a party to the CPTPP.]

[F4 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 or the PPE 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 PPE 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, purchaser, owner, user or maintainer of the PPE which they assess, nor the representative of any of those parties. This does not preclude the use of assessed PPE that are necessary for the operations of the conformity assessment body or the use of such PPE 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, marketing, use or maintenance of PPE, 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 [F5 approved]. 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 V, VII and VIII and in relation to which it has been [F6 approved], 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 of PPE for which it has been [F6 approved], 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 [F7 an approved 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 PPE 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 [F8 approved];

(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 health and safety requirements set out in Annex II, of the applicable [F9 designated] standards, and of the relevant provisions of [F10 this Regulation and any other relevant United Kingdom legislation];

(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 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 unless [F11 the Secretary of State] is directly responsible for the conformity assessment.

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 V, VII and VIII or any provision of [F12 United Kingdom] law giving effect to it, except in relation to the [F13 enforcement authority]. 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 standardisation activities and the activities of [F14 any approved] body coordination group established [F15 by the Secretary of State] and shall apply as general guidance the administrative decisions and documents produced as a result of the work of that group.

Textual Amendments

F1 Art. 24 heading substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(23)(a); 2020 c. 1, Sch. 5 para. 1(1)

F2 Word in Art. 24(1) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(23)(b); 2020 c. 1, Sch. 5 para. 1(1)

F3 Art. 24(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. 17(a)

F4 Art. 24(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. 17(b)

F5 Word in Art. 24(4) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(23)(d); 2020 c. 1, Sch. 5 para. 1(1)

F6 Word in Art. 24(6) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(23)(e)(i); 2020 c. 1, Sch. 5 para. 1(1)

F7 Words in Art. 24(6)(b) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(23)(e)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F8 Word in Art. 24(7)(a) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(23)(d); 2020 c. 1, Sch. 5 para. 1(1)

F9 Word in Art. 24(7)(c) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(23)(f)(i); 2020 c. 1, Sch. 5 para. 1(1)

F10 Words in Art. 24(7)(c) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(23)(f)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F11 Words in Art. 24(9) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(23)(g); 2020 c. 1, Sch. 5 para. 1(1)

F12 Words in Art. 24(10) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(23)(h)(i); 2020 c. 1, Sch. 5 para. 1(1)

F13 Words in Art. 24(10) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(23)(h)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F14 Words in Art. 24(11) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(23)(i)(i); 2020 c. 1, Sch. 5 para. 1(1)

F15 Words in Art. 24(11) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(23)(i)(ii); 2020 c. 1, Sch. 5 para. 1(1)