PART IIGeneral Medical Devices

Procedures for affixing a F2UK marking to general medical devicesE113

1

A relevant device falling within Class I may bear a F8UK marking only if its manufacturer or F1their 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 F3this Part which apply to it; and

c

ensures that the device meets the provisions of F3this Part which apply to it.

2

A relevant device falling within Class IIa may bear a F8UK marking only if its manufacturer or F1their 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 F3this Part which apply to it; and

c

ensures that the device meets the provisions of F3this Part which apply to it.

3

A relevant device falling within Class IIb may bear a F8UK marking only if its manufacturer or F1their 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 F3this Part which apply to it; and

c

ensures that the device meets the provisions of F3this Part which apply to it.

4

A relevant device falling within Class III may bear a F8UK marking only if its manufacturer or F1their 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 F3this Part which apply to it; F7...

c

ensures that the device meets the provisions of F3this Part which apply to it; F5and

F4d

fulfils the obligations imposed by Regulation (EU) No 722/2012 (if applicable).

F65

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F66

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Procedures for affixing a CE marking to general medical devicesE213

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; F12and

F10d

fulfils the obligations imposed by Regulation (EU) No 722/2012 (if applicable).

F115

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F116

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