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The Medical Devices Regulations 2002

The Medical Devices Regulations 2002 Sch 2A para 25

Sch 2A para 25

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.

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