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12.—(1) This regulation applies to machinery—
(a)which falls within a category which is referred to in Annex IV (Part 4 of Schedule 2); and
(b)in respect of which any of the following conditions is satisfied—
(i)that the machinery is not manufactured in accordance with the [F2designated] standards which relate to it; or
(ii)that the machinery is only partly manufactured in accordance with the [F2designated] standards which relate to it; or
(iii)that the [F2designated] standards in accordance with which the machinery is manufactured do not cover all the applicable essential health and safety requirements; or
(iv)that no [F3designated] standards exist for the machinery.
(2) Where this regulation applies, the responsible person shall follow one of the following conformity assessment procedures—
(a)the [F4Type-] examination procedure prescribed in Annex IX (Part 9 of Schedule 2) and the internal checks on the manufacture of machinery prescribed in Annex VIII (Part 8 of Schedule 2), point 3; or
(b)the full quality assurance procedure prescribed in Annex X (Part 10 of Schedule 2).
Extent Information
E1This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F1Word in reg. 12 heading substituted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 12 para. 8(a) (with Sch. 12 para. 22) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
F2Word in reg. 12(1)(b)(i)-(iii) substituted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 12 para. 8(a) (with Sch. 12 para. 22) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
F3Word in reg. 12(1)(b)(iv) substituted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 12 para. 8(b) (with Sch. 12 para. 22) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
F4Word in reg. 12(2)(a) substituted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 12 para. 8(c) (with Sch. 12 para. 22) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
12.—(1) This regulation applies to machinery—
(a)which falls within a category which is referred to in Annex IV (Part 4 of Schedule 2); and
(b)in respect of which any of the following conditions is satisfied—
(i)that the machinery is not manufactured in accordance with the published harmonised standards which relate to it; or
(ii)that the machinery is only partly manufactured in accordance with the published harmonised standards which relate to it; or
(iii)that the published harmonised standards in accordance with which the machinery is manufactured do not cover all the applicable essential health and safety requirements; or
(iv)that no harmonised standards exist for the machinery.
(2) Where this regulation applies, the responsible person shall follow one of the following conformity assessment procedures—
(a)the EC type-examination procedure prescribed in Annex IX (Part 9 of Schedule 2) and the internal checks on the manufacture of machinery prescribed in Annex VIII (Part 8 of Schedule 2), point 3; or
(b)the full quality assurance procedure prescribed in Annex X (Part 10 of Schedule 2).
Extent Information
E2This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only