The Medical Devices Regulations 2002

34B.—(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;

“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.]

Textual Amendments