The Medical Devices Regulations 2002 No. 618

PART IV U.K. In Vitro Diagnostic Medical Devices

Scope of Part IV U.K.

33.—(1) The requirements of this Part in respect of relevant devices apply in respect ofin vitro diagnostic medical devices [F1 (including coronavirus test devices)] and accessories to such devices, except for—

(a) products manufactured and used within the same health institution and either on the premises of their manufacture or on premises in the immediate vicinity without having been transferred to another legal entity; [F2 and]

(b) [F3 devices that come within the scope of Directive 98/79 and another Directive (“the other Directive”) issued by one or more of the institutions of the Community, and

(i) the other Directive includes a provision allowing the manufacturer of the device to choose, during a transitional period that has not ended, which set of arrangements applies to it, and

(ii) the manufacturer chooses to follow the set of arrangements in the other Directive.]

(2) The requirements of this Part in respect of devices for performance evaluation do not apply in respect of—

(a) products manufactured and used only within the same health institution and either on the premises of their manufacture or on premises in the immediate vicinity without having been transferred to another legal entity; [F4 and]

(b) [F5 devices that come within the scope of Directive 98/79 and another Directive (“the other Directive”) issued by one or more of the institutions of the Community, and

(i) the other Directive includes a provision allowing the manufacturer of the device to choose, during a transitional period that has not ended, which set of arrangements applies to it, and

(ii) the manufacturer chooses to follow the set of arrangements in the other Directive.]

Textual Amendments

F1 Words in reg. 33(1) inserted (28.7.2021) by The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 (S.I. 2021/910), regs. 1(1), 4

F2 Word in reg. 33(1)(a) omitted (E.W.S) (11.8.2021) by virtue of The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 16(a)(i)

F3 Reg. 33(1)(b) omitted (E.W.S.) (11.8.2021) by virtue of The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 16(a)(ii)

F4 Word in reg. 33(2)(a) omitted (E.W.S.) (11.8.2021) by virtue of The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 16(b)(i)

F5 Reg. 33(2)(b) omitted (E.W.S.) (11.8.2021) by virtue of The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 16(b)(ii)