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The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024
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- UK Statutory Instruments
- 2024 No. 221
- PART 3
- Regulation 11
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Amendment to regulation 2A (medical devices which are qualifying Northern Ireland goods)
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11. In regulation 2A(1)—
(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)Regulation (EU) 2017/745; or
(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.”.
(1)
Regulation 2A was inserted by S.I. 2019/791 and amended by S.I. 2021/905.
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