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PART IIU.K.General Medical Devices

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

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