The Medical Devices Regulations 2002

Procedures for affixing a [F1 UK marking] to in vitro diagnostic medical devices E+W+S

40.—(1) A relevant device other than a device referred to in the lists in Annex II or a device for self-testing may bear a [F2 UK marking] only if its manufacturer or [F3 their UK responsible person]—

(a) fulfils the applicable obligations imposed by Sections 1 to 5 of Annex III;

(b) declares, in accordance with the declaration of conformity procedure set out in that Annex, that the device meets the provisions of [F4 this Part] which apply to it; and

(c) ensures that the device meets the provisions of [F4 this Part] which apply to it.

(2) A relevant device which is a device for self-testing but which is not referred to in a list in Annex II may bear a [F2 UK marking] only if its manufacturer or [F3 their UK responsible person]—

(a) fulfils the applicable obligations imposed by—

(i) Sections 1 to 6 of Annex III,

(ii) Annex IV, or

(iii) Annex V and either Annex VI or Annex VII;

(b) declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of [F4 this Part] which apply to it; and

(c) ensures that the device meets the provisions of [F4 this Part] which apply to it.

(3) A relevant device referred to in List A in Annex II may bear a [F2 UK marking] only if its manufacturer or [F3 their UK responsible person]—

(a) fulfils the applicable obligations imposed by—

(i) Annex IV, or

(ii) Annexes V and VII;

(b) declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of [F4 this Part] which apply to it; and

(c) ensures that the device meets the provisions of [F4 this Part] which apply to it.

(4) A relevant device referred to in List B in Annex II may bear a [F2 UK marking] only if its manufacturer or [F3 their UK responsible person]—

(a) fulfils the applicable obligations imposed by—

(i) Annex IV,

(ii) Annexes V and VI, or

(iii) Annexes V and VII;

(b) declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of [F4 this Part] which apply to it; and

(c) ensures that the device meets the provisions of [F4 this Part] which apply to it.

Extent Information

E1 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F1 Words in reg. 40 heading substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), reg. 6(5A)(a) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 41); 2020 c. 1, Sch. 5 para. 1(1)

F2 Words in reg. 40 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), reg. 6(5A)(a) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 41); 2020 c. 1, Sch. 5 para. 1(1)

F3 Words in reg. 40 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), reg. 6(5A)(b) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 41); 2020 c. 1, Sch. 5 para. 1(1)

F4 Words in reg. 40 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), reg. 6(5A)(c) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 41); 2020 c. 1, Sch. 5 para. 1(1)

Procedures for affixing a CE marking to in vitro diagnostic medical devices N.I.

40.—(1) A relevant device other than a device referred to in the lists in Annex II or a device for self-testing may bear a CE marking only if its manufacturer or his authorised representative—

(a) fulfils the applicable obligations imposed by Sections 1 to 5 of Annex III;

(b) declares, in accordance with the declaration of conformity procedure set out in that Annex, that the device meets the provisions of Directive 98/79 which apply to it; and

(c) ensures that the device meets the provisions of Directive 98/79 which apply to it.

(2) A relevant device which is a device for self-testing but which is not referred to in a list in Annex II may bear a CE marking only if its manufacturer or his authorised representative—

(a) fulfils the applicable obligations imposed by—

(i) Sections 1 to 6 of Annex III,

(ii) Annex IV, or

(iii) Annex V and either Annex VI or Annex VII;

(b) declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of Directive 98/79 which apply to it; and

(c) ensures that the device meets the provisions of Directive 98/79 which apply to it.

(3) A relevant device referred to in List A in Annex II may bear a CE marking only if its manufacturer or his authorised representative—

(a) fulfils the applicable obligations imposed by—

(i) Annex IV, or

(ii) Annexes V and VII;

(b) declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of Directive 98/79 which apply to it; and

(c) ensures that the device meets the provisions of Directive 98/79 which apply to it.

(4) A relevant device referred to in List B in Annex II may bear a CE marking only if its manufacturer or his authorised representative—

(a) fulfils the applicable obligations imposed by—

(i) Annex IV,

(ii) Annexes V and VI, or

(iii) Annexes V and VII;

(b) declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of Directive 98/79 which apply to it; and

(c) ensures that the device meets the provisions of Directive 98/79 which apply to it.

Extent Information

E2 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only