The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021
1Citation, commencement and extent
2Amendment of the Medical Devices Regulations 2002
3In regulation 2 after the definition of “clinical data”, insert—...
4In regulation 33(1) after “in vitro diagnostic medical devices”, insert...
5After regulation 34, insert— Approval requirement for coronavirus test devices...
6After regulation 38, insert— Applications for approval of coronavirus test...
7In regulation 39 in the heading, for “regulations 34, 36...
8After regulation 39, insert— Exemptions for coronavirus test devices (1) Regulation 34A does not apply where, in circumstances which...
9After regulation 56 (fees payable in relation to clinical investigation...
10Review
2021 No. 910
Medical Devices

The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021

Made
Coming into force
The Secretary of State has carried out a public consultation, and makes these Regulations in exercise of the powers conferred by sections 15(1), 16(1)(a), (b), (c) and (h), 17(1)(a), 18 and 43 of the Medicines and Medical Devices Act 20211 and after having considered the matters set out in section 15(2) to (4) of that Act.

In accordance with section 47(3) and (6)(a) of that Act, a draft of this instrument has been laid before and approved by a resolution of each House of Parliament.