F1SCHEDULE 2AModification of Annexes to Directives 90/385, 93/42, 98/79
PART 3Modification of Annexes to Directive 98/79
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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”;
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”.
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)