# The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021, Regulation 8: Amendment of the Medical Devices Regulations 2002


After regulation 39, insert—
“Exemptions for coronavirus test devices
39A. (1) Regulation 34A does not apply where, in circumstances which give rise to a need to protect the public from a risk of serious harm to health, the Secretary of State—
(a) has decided to permit, where appropriate for a specified period, the placing on the market or putting into service of a particular coronavirus test device or coronavirus test devices of a particular class or description that has not been approved under regulation 38A(5); and
(b) has not withdrawn that permission.
(2) The Secretary of State may give permission under paragraph (1) subject to such conditions as are set out in a protocol published by the Secretary of State.
(3) If the Secretary of State publishes a protocol for the purpose of paragraph (2), the protocol must specify the period of time for which it has effect.
(4) The Secretary of State may withdraw or amend a protocol published under paragraph (2).”.

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Source: https://www.legislation.gov.uk/ukdsi/2021/9780348224795/regulation/8 (the official version)
Page: https://openlegislation.uk/draft-medical-devices-coronavirus-test-device-approvals-amendment-regulations-2021/regulation-8
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.