Paragraph 25 F1

In Annex 1—

(a)

in Section 3 in part A, for “Article 1(2)(b)” substitute “regulation 2(1) of the Regulations”;

(b)

in Section 4.2 in part B, for “Council Directive 80/181/EEC of 20th December 1979” substitute “the Units of Measurement Regulations 1986”;

(c)

in Section 8.1 in part B, omit the words from “The decision whether” to the end;

(d)

in Section 8.2 in part B, for “harmonised standards” substitute “designated standards”;

(e)

in Section 8.3 in part B —

(i)

in the first sentence omit “of Directive 67/548/EEC and Directive 88/379/EEC”;

(ii)

in the second sentence omit “by those Directives”;

(iii)

omit the words from “The provisions of” to the end;

(f)

in Section 8.4 in point (a), for the sentence beginning “For devices imported”, substitute—

“Where the manufacturer does not have a registered place of business in the United Kingdom the label, the outer packaging or instructions for use shall contain in addition the name and address of the UK responsible person.”.

Annotations

Textual amendments

F1: Sch. 2A inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 12 (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 56, 57); 2020 c. 1, Sch. 5 para. 1(1)