OpenLegislation

Regulation 40 Procedures for affixing a UK marking to in vitro diagnostic medical devicesF4E1

England, Wales and Scotland

(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 F1UK marking only if its manufacturer or F2their 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 F3this Part which apply to it; and

(c)

ensures that the device meets the provisions of 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 UK marking only if its manufacturer or 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 this Part which apply to it; and

(c)

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

(3)

A relevant device referred to in List A in Annex II may bear a UK marking only if its manufacturer or 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 this Part which apply to it; and

(c)

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

(4)

A relevant device referred to in List B in Annex II may bear a UK marking only if its manufacturer or 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 this Part which apply to it; and

(c)

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

Annotations

Textual amendments

F1

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)

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)(b) (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)(c) (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 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)

Extent

E1

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