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The Medical Devices Regulations 2002

The Medical Devices Regulations 2002 Sch 2A para 26

Sch 2A para 26

In Annex III— (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”; (iii) for “CE marking in accordance with Article 16” substitute “UK marking in accordance with regulation 36 of the Regulations”; (c) in Section 3, for “the Directive” in both places substitute “the Regulations”; (d) in Section 3, in the sixth indent, for “Article 5” in both places substitute “regulation 3A of the Regulations”; (e) omit Section 5; (f) in Section 6, for “a notified body” substitute “an approved body”; (g) in Section 6.2— (i) for “notified body”, both times those words occur, substitute “approved body”; (ii) in the first sentence, for “this Directive” substitute “the Regulations”; (iii) in the second sentence omit “of the Directive”; (iv) for “an EC” substitute “a” ; (h) in Section 6.3— (i) for “notified body” in both places substitute “approved body”; (ii) omit each reference to “EC”; (iii) for “the Directive” substitute “the Regulations”.

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