PART 3Testing prior to arrival in Scotland

Part 3: interpretation7.

(1)

In this Part—

device” means an in vitro diagnostic medical device within the meaning given in regulation 2(1) of the Medical Devices Regulations 2002 M1,

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

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

(2)

For the purposes of this Part—

(a)

a test is a qualifying test if it complies with regulation 9(1), and

(b)

a notification of a negative result is valid if—

F1(i)

it is provided through the EU Digital F2COVID Certificate, or

(ii)

it includes the information specified in regulation 9(2).