Textual Amendments
F1Sch. 2A inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 12 (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 56, 57); 2020 c. 1, Sch. 5 para. 1(1)
29. In Annex VI—E+W+S
(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”;
(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”.]