Amendment to regulation 34

1

Regulation 3 (applicable tests) is amended as follows.

2

In paragraph (1)—

a

omit sub-paragraph (a);

b

in sub-paragraph (b) after “provided” insert “, by or on behalf of a testing service provider,”;

c

after sub-paragraph (d) insert—

da

not carried out using a device for self-testing.

d

omit sub-paragraph (e).

3

In paragraph (2)—

a

after sub-paragraph (a) insert—

aa

device for self-testing” has the same meaning as in regulation 32(1) of the Medical Devices Regulations 20023.

b

omit sub-paragraph (b).