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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 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).
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