The Medical Devices Regulations 2002

Procedures for affixing a [F1UK marking] to active implantable medical devicesE+W+S

27.  A relevant device may bear a [F2UK marking] only if its manufacturer or [F3their UK responsible person]—

(a)fulfils the applicable obligations imposed by—

(i)Annex 2, or

(ii)Annex 3, together with Annex 4 or 5;

(b)declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of [F4this Part] that 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).]

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 active implantable medical devicesN.I.

27.  A relevant device may bear a CE marking only if its manufacturer or his authorised representative—

(a)fulfils the applicable obligations imposed by—

(i)Annex 2, or

(ii)Annex 3, together with Annex 4 or 5;

(b)declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of Directive 90/385 that apply to it; F8...

(c)ensures that the device meets the provisions of Directive 90/385 which apply to it; [F9and]

[F10(d)fulfils the obligations imposed by Regulation (EU) No 722/2012 (if applicable).]

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