Regulation 34A Approval requirement for coronavirus test devicesF1

(1)

Subject to regulations F234B to 34D, 39(1) and 39A, no person other than the Secretary of State may place on the market or put into service a coronavirus test device, unless—

(a)

the Secretary of State has approved it in accordance with regulation 38A(5); and

(b)

the approval remains valid in accordance with regulation 38A(6).

(2)

Subject to regulations F334B to 34D, 39(1) and 39A, no person other than the Secretary of State may supply a coronavirus test device—

(a)

if that supply is also a placing on the market or putting into service of that device; or

(b)

in circumstances where that device has been placed on the market or put into service,

unless the Secretary of State has approved it in accordance with regulation 38A(5) and the approval remains valid in accordance with regulation 38A(6).

(3)

The requirements in paragraphs (1) and (2) are without prejudice to the other requirements of this Part.

Annotations

Textual amendments

F1: Regs. 34A-34C inserted (28.7.2021) by The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 (S.I. 2021/910), regs. 1(1), 5
F2: Words in reg. 34A(1) substituted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 16
F3: Words in reg. 34A(2) substituted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 16