Regulation 11 Amendment to regulation 2A (medical devices which are qualifying Northern Ireland goods)
In regulation 2Af1—
(a)
in paragraph (1)—
(i)
before “Notwithstanding” insert “Subject to paragraph (1A),”;
(ii)
for sub-paragraph (a) substitute—
“(a)which meets the requirements of—
(i)these Regulations as they apply in Northern Ireland;
(ii)(iii)Regulation (EU) 2017/746; and”;
(b)
after paragraph (1) insert—
“(1A)Before 25 July 2024, paragraph (1) only applies to a coronavirus test device that meets the requirements of Regulation (EU) 2017/746 if the device also meets the requirements of—
(a)regulation 34A (approval requirement for coronavirus test devices); or
(b)the common specifications set out in Annex I and XIII to Regulation (EU) 2022/1107.”.
Annotations
Footnotes
- f1
-
Regulation 2A was inserted by S.I. 2019/791 and amended by S.I. 2021/905.