Sch 2A para 30
In Annex VII— (a) in the title and in Section 2, omit “EC”; (b) in Section 2— (i) for “this Directive” substitute “the Regulations”; (ii) for “CE marking in accordance with Article 16” substitute “UK marking in accordance with regulation 36 of the Regulations”; (c) in Section 3.1— (i) for “a notified body” substitute “an approved body”; (ii) for “EC type-examination” substitute “type-examination”; (d) in Section 3.2, for “EC type-examination” substitute “type-examination”; (e) in Section 3.3 for the first two sentences substitute— The quality system must be audited by the approved body to determine whether it meets the requirements referred to in Section 3.2. The approved body must presume that quality systems which implement the relevant designated standards conform to the requirements. (f) in Section 3.4— (i) for “notified body” substitute “approved body”; (ii) for the first sentence of the second paragraph substitute “The proposed changes must be assessed by the approved body so as to verify whether the quality system after these changes would meet the requirements referred to in Section 3.2.”; (g) in Sections 5.1 and 5.2, for each reference to “notified body” substitute “approved body”.