# The Medical Devices Regulations 2002, Paragraph 18


In Annex VII—
(a) in the title and in Section 1, omit “EC”;
(b) in Section 1—
(i) for “authorised representative” substitute “UK responsible person”;
(ii) for “this Directive” substitute “the Regulations”;
(c) in Section 2 for—
(i) “his authorised representative” substitute “the manufacturer’s UK responsible person”;
(ii) “national authorities” substitute “Secretary of State”;
(d) in Section 3—
(i) in the opening paragraph for “the Directive” substitute “the Regulations”;
(ii) in the fourth indent—
(aa) for “Article 5” in both places it occurs substitute “regulation 3A of the Regulations”;
(bb) for “of the Directive” substitute “in Annex I”;
(e) omit Section 4;
(f) in Section 5, for “the intervention by the notified body” substitute “the intervention by the approved body”;
(g) in Section 6, in the opening paragraph, for “Article 11(2)” substitute “regulation 13(2) of the Regulations”.

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Source: https://www.legislation.gov.uk/uksi/2002/618/schedule/2A/paragraph/18 (the official version)
Page: https://openlegislation.uk/medical-devices-regulations-2002/schedule-2A/paragraph-18
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.