Section 18 Emergencies
(1)
Regulations under section 15(1) may make provision about the disapplication of a medical devices provision in circumstances which give rise to a need to protect the public from a risk of serious harm to health.
(2)
Regulations made in reliance on subsection (1) may provide for the disapplication to be subject to—
(a)
conditions set out in the regulations;
(b)
conditions set out in a protocol published by the Secretary of State.
(3)
Where regulations made in reliance on subsection (1) provide that the Secretary of State may publish a protocol setting out conditions, the regulations must provide—
(a)
that the Secretary of State may withdraw or amend the protocol, and
(b)
that the protocol is to have effect only for a period of time specified in the protocol.