PART IVIn Vitro Diagnostic Medical Devices
F1Public sector use of coronavirus test devices34B
1
Regulation 34A(1) does not apply in relation to a coronavirus test device that is placed on the market or put into service only for use by—
a
the Secretary of State;
b
a devolved public health body; or
c
a health service body supplied pursuant to an existing contract.
2
Regulation 34A(2) does not apply in relation to a coronavirus test device that is supplied to—
a
the Secretary of State;
b
a devolved public health body; or
c
a health service body pursuant to an existing contract.
3
In this regulation—
“a devolved public health body” is—
- a
in Wales, Welsh Ministers or Public Health Wales National Health Service Trust;
- b
in Scotland, Scottish Ministers;
- c
in Northern Ireland, the Department of Health in Northern Ireland;
- a
“an existing contract” is a contract entered into before the coming into force of regulation 34A;
“a health service body” is—
- a
an NHS body as defined in section 275 of the National Health Service Act 2006 or in section 206 of the National Health Service (Wales) Act 2006;
- b
a body listed in section 17A(2)(a) to (c) or (e) of the National Health Service (Scotland) Act 1978; or
- c
a health and social care body as defined in section 1(5)(a) to (e) of the Health and Social Care (Reform) Act (Northern Ireland) 2009.
- a