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The Medical Devices Regulations 2002

The Medical Devices Regulations 2002 Sch 2A para 29

Sch 2A para 29

In Annex VI— (a) in the title omit “EC”; (b) in Section 1— (i) for “EC verification” substitute “Verification”; (ii) for “authorised representative” substitute “UK responsible person”; (iii) for “EC type-examination” substitute “type-examination”; (iv) for “this Directive” substitute “the Regulations”; (c) in Section 2.1— (i) for “EC type-examination” in both places substitute “type-examination”; (ii) for “the Directive” substitute “the Regulations”; (iii) for “this Directive” substitute “the Regulations”; (d) in Section 2.2 for “notified body” substitute “approved body”; (da) omit Section 3; (e) in Section 4— (i) for “notified body” in both places substitute “approved body”; (ii) for “the Directive” substitute “the Regulations”; (f) in Section 5.1— (i) for “Article 5” substitute “regulation 3A of the Regulations”; (ii) omit “EC”; (iii) for “the Directive” substitute “the Regulations”; (g) in Section 5.2 for “notified body” substitute “approved body”; (h) in Section 6.2— (i) for “Article 5” substitute “regulation 3A of the Regulations”; (ii) omit “EC”; (iii) for “the Directive” substitute “the Regulations”; (i) in Section 6.3 for “the harmonised standards referred to in Article 5” substitute “the designated standards referred to in regulation 3A of the Regulations”; (j) in Section 6.4— (i) for the first two paragraphs, substitute— Where the approved body has drawn up a written certificate of conformity in relation to a batch, all products in that batch to which that body has affixed, or caused to be affixed, an identification number may be placed on the market. (ii) in the third paragraph, for “notified body”, in both places, substitute “approved body”.

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