The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024
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Change 1
11 Amendment to regulation 2A (medical devices which are qualifying Northern Ireland goods)
In regulation 2A— (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. .
11 Amendment to regulation 2A (medical devices which are qualifying Northern Ireland goods)
In regulation 2A— (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. .
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