Legislation – The Health Protection (Coronavirus, Testing Requirements and Standards) (England) Regulations 2020

Test requirements4.

(1)

Any device used for the purposes of an applicable test must meet the following requirements—

(a)

it can be put into service in accordance with Part 4 of the Medical Devices Regulations 20024, other than solely by virtue of regulation 39(2) of those Regulations;

(b)

it has been validated no more than 18 months before the test is administered.

(2)

In this regulation “validated”, in relation to a device, means confirmed by—

(a)

the Secretary of State;

(b)

the National Institute for Health and Care Excellence5; or

(c)

a laboratory which is accredited by UKAS to ISO standard 151896 or ISO/IEC standard 170257, other than a laboratory which processes tests provided by the test provider or is owned by the test provider,

as having the levels of sensitivity and specificity stated by the manufacturer.

(3)

In this regulation—

(a)

“device” means an in vitro diagnostic medical device within the meaning given in regulation 2(1) of the Medical Devices Regulations 2002;

(b)

“sensitivity”, in relation to a device, means how often the device correctly generates a positive result;

(c)

“specificity”, in relation to a device, means how often the device correctly generates a negative result.