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—

    1. a

      in Wales, Welsh Ministers or Public Health Wales National Health Service Trust;

    2. b

      in Scotland, Scottish Ministers;

    3. c

      in Northern Ireland, the Department of Health in Northern Ireland;

  • “an existing contract” is a contract entered into before the coming into force of regulation 34A;

  • “a health service body” is—

    1. 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;

    2. b

      a body listed in section 17A(2)(a) to (c) or (e) of the National Health Service (Scotland) Act 1978; or

    3. 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.