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27. A relevant device may bear a CE marking only if its manufacturer or his authorised representative—
(a)fulfils the applicable obligations imposed by—
(i)Annex 2, or
(ii)Annex 3, together with Annex 4 or 5;
(b)declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of Directive 90/385 that apply to it; and
(c)ensures that the device meets the provisions of Directive 90/385 which apply to it.
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