Procedures for affixing a [F1UK marking] to general medical devicesE+W+S
13.—(1) A relevant device falling within Class I may bear a [F2UK marking] only if its manufacturer or [F3their 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 [F4this Part] which apply to it; and
(c)ensures that the device meets the provisions of [F4this Part] which apply to it.
(2) A relevant device falling within Class IIa may bear a [F2UK marking] only if its manufacturer or [F3their 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 [F4this Part] which apply to it; and
(c)ensures that the device meets the provisions of [F4this Part] which apply to it.
(3) A relevant device falling within Class IIb may bear a [F2UK marking] only if its manufacturer or [F3their 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 [F4this Part] which apply to it; and
(c)ensures that the device meets the provisions of [F4this Part] which apply to it.
(4) A relevant device falling within Class III may bear a [F2UK marking] only if its manufacturer or [F3their 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 [F4this Part] which apply to it; F5...
(c)ensures that the device meets the provisions of [F4this Part] which apply to it; [F6and]
[F7(d)fulfils the obligations imposed by Regulation (EU) No 722/2012 (if applicable).]
F8(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F8(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Extent Information
E1This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F1Words 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)
F2Words 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)
F3Words 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)
F4Words 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)
F5Word 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)
F6Word 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)
F7Reg. 13(4)(d) added (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 4(2)(c)
F8Reg. 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)
Procedures for affixing a CE marking to general medical devicesN.I.
13.—(1) A relevant device falling within Class I may bear a CE marking only if its manufacturer or his authorised representative—
(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 Directive 93/42 which apply to it; and
(c)ensures that the device meets the provisions of Directive 93/42 which apply to it.
(2) A relevant device falling within Class IIa may bear a CE marking only if its manufacturer or his authorised representative—
(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 Directive 93/42 which apply to it; and
(c)ensures that the device meets the provisions of Directive 93/42 which apply to it.
(3) A relevant device falling within Class IIb may bear a CE marking only if its manufacturer or his authorised representative—
(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 Directive 93/42 which apply to it; and
(c)ensures that the device meets the provisions of Directive 93/42 which apply to it.
(4) A relevant device falling within Class III may bear a CE marking only if its manufacturer or his authorised representative—
(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 Directive 93/42 which apply to it; F9...
(c)ensures that the device meets the provisions of Directive 93/42 which apply to it; [F10and]
[F11(d)fulfils the obligations imposed by Regulation (EU) No 722/2012 (if applicable).]
F12(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F12(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Extent Information
E2This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
Textual Amendments
F9Word 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)
F10Word 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)
F11Reg. 13(4)(d) added (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 4(2)(c)
F12Reg. 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)