Paragraph 29 F1

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”;

(F2da)

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”.

Annotations

Textual amendments

F1: Sch. 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)
F2: Sch. 2A para. 29(da) inserted (17.6.2025) by The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368), regs. 1(2), 5(14) (with reg. 6)