The Medical Devices Regulations 2002

Procedures for affixing a CE marking to general medical devices

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; and

(c) ensures that the device meets the provisions of Directive 93/42 which apply to it.