Amendment of regulation 143
1
Regulation 14 (requirement to undertake tests) is amended in accordance with paragraphs (2) to (4).
2
After paragraph (1), insert—
1A
If a test is to be self-administered, P must undertake a test in accordance with the manufacturer’s instructions for use.
3
For paragraph (9)(b), substitute—
b
the test is—
i
where P is a red list arrival or not an eligible vaccinated arrival, a test which complies with paragraph (9A),
ii
where P is an eligible vaccinated arrival, a test which complies with paragraph (9B).
4
After paragraph (9), insert—
9A
For the purposes of paragraph (9)(b)(i), a test complies with this paragraph if it is a semi-quantitative test for the detection of coronavirus which targets a minimum of two distinguishable SARS-CoV-2 genes other than the S gene and performance reference controls.
9B
For the purposes of paragraph (9)(b)(ii), a test complies with this paragraph if—
a
it is a test for the detection of coronavirus which uses one or more of—
i
mid-turbinate or anterior nares nasal swabbing,
ii
tonsillar swabbing,
iii
saliva,
b
the test is uniquely identifiable,
c
the test is provided in accordance with the test manufacturer’s instructions for use including, in particular, instructions as to the target use, target user and target use settings, and
d
any device used for the purposes of the test can be put into service in accordance with Part 4 of the Medical Devices Regulations 20023, other than solely by virtue of regulation 39(2) of those Regulations.