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)
28. In Annex V—E+W+S
(a)in the title, omit “EC” ;
(b)in Section 1—
(i)for “EC type-examination” substitute “Type-examination”;
(ii)for “a notified body” substitute “an approved body”;
(iii)for “this Directive” substitute “the Regulations”;
(c)in Section 2—
(i)in the first paragraph—
(aa )omit “EC”;
(bb)for “his authorised representative” substitute “its UK responsible person”;
(cc)for “a notified body” substitute “an approved body”;
(ii)in the first indent—
(aa)for “authorised representative” substitute “UK responsible person”;
(bb)for “the representative” substitute “the UK responsible person”;
(iii)in the second indent for “this Directive” substitute “the Regulations”;
(iv)in the second and third indents for “notified body” each time those words occur substitute “approved body”;
(d)in Section 4—
(i)for “notified body shall” substitute “approved body must”;
(ii)for both references to “Article 5” substitute “regulation 3A of the Regulations”;
(iii)for “this Directive” substitute “the Regulations”;
(e)in Section 5—
(i)for “this Directive” substitute “the Regulations”;
(ii)for “notified body” in both places substitute “approved body”;
(iii)for “an EC” substitute “a”;
(f)in Section 6—
(i)for “notified body” each time it occurs substitute “approved body”;
(ii)omit “EC” each time it occurs;
(iii)for “the Directive” substitute “the Regulations”;
(g)for Section 7, substitute—
“7. An approved body must cooperate with other approved bodies with regard to making available copies of the type-examination certificates or addenda to those certificates but, as regards copies of annexes to the certificates, must only make those available to other approved bodies with the consent of the manufacturer.”.]