OpenLegislation

Regulation 13 Procedures for affixing a UK marking to general medical devicesF8E1

England, Wales and Scotland

(1)

A relevant device falling within Class I may bear a F1UK marking only if its manufacturer or F2their UK responsible person—

(a)

fulfils the applicable obligations imposed by Annex VII;

(b)

declares, in accordance with the declaration of conformity procedure set out in that Annex, that the device meets the provisions of F3this Part which apply to it; and

(c)

ensures that the device meets the provisions of this Part which apply to it.

(2)

A relevant device falling within Class IIa may bear a UK marking only if its manufacturer or their UK responsible person—

(a)

fulfils the applicable obligations imposed by—

(i)

Annex II, excluding Section 4 of that Annex, or

(ii)

Annex VII, together with Annex IV, V or VI;

(b)

declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of this Part which apply to it; and

(c)

ensures that the device meets the provisions of this Part which apply to it.

(3)

A relevant device falling within Class IIb may bear a UK marking only if its manufacturer or their UK responsible person—

(a)

fulfils the applicable obligations imposed by—

(i)

Annex II, excluding Section 4 of that Annex, or

(ii)

Annex III, together with Annex IV, V or VI;

(b)

declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of this Part which apply to it; and

(c)

ensures that the device meets the provisions of this Part which apply to it.

(4)

A relevant device falling within Class III may bear a UK marking only if its manufacturer or their UK responsible person—

(a)

fulfils the applicable obligations imposed by—

(i)

Annex II, or

(ii)

Annex III, together with Annex IV or V;

(b)

declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of this Part which apply to it; F4...

(c)

ensures that the device meets the provisions of this Part which apply to it; F5and

F6(d)

fulfils the obligations imposed by Regulation (EU) No 722/2012 (if applicable).

F7(5)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(6)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Annotations

Textual amendments

F1

Words in reg. 13 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(7A)(c) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 17); 2020 c. 1, Sch. 5 para. 1(1)

F2

Words in reg. 13 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(7A)(d) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 17); 2020 c. 1, Sch. 5 para. 1(1)

F3

Words in reg. 13 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(7A)(b) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 17); 2020 c. 1, Sch. 5 para. 1(1)

F4

Word in reg. 13(4)(b) omitted (21.10.2013) by virtue of The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 4(2)(a)

F5

Word in reg. 13(4)(c) added (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 4(2)(b)

F6

Reg. 13(4)(d) added (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 4(2)(c)

F7

Reg. 13(5)(6) omitted (21.10.2013) by virtue of The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 4(3)

F8

Words in reg. 13 heading substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(7A)(a) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 17); 2020 c. 1, Sch. 5 para. 1(1)

Extent

E1

This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only