# The Medical Devices Regulations 2002, Paragraph 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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Source: https://www.legislation.gov.uk/uksi/2002/618/schedule/2A/paragraph/25 (the official version)
Page: https://openlegislation.uk/medical-devices-regulations-2002/schedule-2A/paragraph-25
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.