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

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Introduction

1 Citation, commencement and extent

2 Amendment of the Medical Devices Regulations 2002

3 In regulation 2 after the definition of “clinical data”, insert—…

4 In regulation 33(1) after “in vitro diagnostic medical devices”, insert…

5 After regulation 34, insert— Approval requirement for coronavirus test devices…

6 After regulation 38, insert— Applications for approval of coronavirus test…

7 In regulation 39 in the heading, for “regulations 34, 36…

8 After regulation 39, insert— Exemptions for coronavirus test devices (1) Regulation 34A does not apply where, in circumstances which…

9 After regulation 56 (fees payable in relation to clinical investigation…

10 Review

Signature

Explanatory note

Which version?
Latest available (Revised)
Original (As enacted)

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Nadhim Zahawi
Parliamentary Under Secretary of State,
Department of Health and Social Care
27th July 2021
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