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.
[F1(5) Notwithstanding that the requirement in paragraph (1) to (4) is satisfied, subject to paragraph (6), where a relevant device is manufactured utilising either animal tissue which is rendered non-viable or non-viable products derived from animal tissue its manufacturer or his authorised representative must—
(a)carry out the risk analysis and risk management procedures set out in the Annex to Directive 2003/32; and
(b)fulfil his obligations under those procedures
before the device may bear a CE marking.
(6) Paragraph (5) shall not apply to a relevant device which is not intended to come into contact with the human body or which is intended to come into contact with intact skin only.]
Textual Amendments
F1Reg. 13(5)(6) added (1.4.2004) by The Medical Devices (Amendment) Regulations 2003 (S.I. 2003/1697), regs. 1(1)(b), 6