# The Medical Devices Regulations 2002, Paragraph 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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Source: https://www.legislation.gov.uk/uksi/2002/618/schedule/2A/paragraph/29 (the official version)
Page: https://openlegislation.uk/medical-devices-regulations-2002/schedule-2A/paragraph-29
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.