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has not withdrawn that permission.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).”.