PART IIGeneral Medical Devices
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; and
c
ensures that the device meets the provisions of Directive 93/42 which apply to it.