PART IVIn Vitro Diagnostic Medical Devices
F1Exemptions for coronavirus test devices39A.
(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has not withdrawn that permission.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).