PART 3 General prohibitions and obligations

Conformity assessment procedures

Annex IV machinery not manufactured fully in accordance with published harmonised standards or not fully covered by such standards

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).