PART IIGeneral Medical Devices
Procedures for affixing a F1UK marking to general medical devices13.
(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)
F7(d)
fulfils the obligations imposed by Regulation (EU) No 722/2012 (if applicable).
F8(5)
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F8(6)
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Procedures for affixing a CE marking to general medical devices13.
(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)
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F12(6)
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