PART 3Conformity of apparatus and equipment
Presumption of conformity
39.—(1) Equipment which is in conformity with a harmonised standard (or part of such a standard) the reference to which has been published in the Official Journal is to be presumed to be in conformity with the essential requirements covered by that standard (or that part of that standard).
(2) The presumption in paragraph (1) is rebuttable.
Conformity assessment procedures
40.—(1) Subject to paragraph (2), the manufacturer must demonstrate the conformity of the apparatus with the essential requirements by means of either—
(a)the procedure set out in Schedule 2 (Module A: internal production control); or
(b)the procedures set out in Schedule 3 (Module B: EU type examination followed by Module C: conformity to type based on internal production control).
(2) The manufacturer may choose to demonstrate the conformity of apparatus with some of the essential requirements by following the procedure referred to in paragraph (1)(b) provided that the procedure referred to in paragraph (1)(a) is followed for the remaining essential requirements.
EU declaration of conformity
41. The EU declaration of conformity for apparatus must—
(a)state that the fulfilment of the essential requirements has been demonstrated in respect of the apparatus;
(b)contain the elements of the relevant conformity assessment procedure or procedures followed in respect of the apparatus; and
(c)have the model structure set out in Schedule 4.
CE marking
42.—(1) The CE marking must be affixed visibly, legibly and indelibly to the apparatus or to its data plate.
(2) Where it is not possible or warranted, on account of the nature of the apparatus, to affix the CE marking in accordance with paragraph (1), the CE marking must be affixed to—
(a)the packaging; and
(b)the accompanying documents.