The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024
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Change 1
17 New regulation 34D (exemption for coronavirus test devices in conformity with Regulation (EU) 2017/746 and Regulation (EU) 2022/1107)
After regulation 34C (transitional provisions for coronavirus test devices) insert— Exemption for coronavirus test devices in conformity with Regulation (EU) 2017/746 and Regulation (EU) 2022/1107 34D. Regulation 34A does not apply in Northern Ireland— (a) in relation to a coronavirus test device that is in conformity with Regulation (EU) 2017/746 and the common specifications set out in Annex I and XIII to Regulation (EU) 2022/1107; (b) after 24 July 2024, in relation to a coronavirus test device that is in conformity with Regulation (EU) 2017/746. .
17 New regulation 34D (exemption for coronavirus test devices in conformity with Regulation (EU) 2017/746 and Regulation (EU) 2022/1107)
After regulation 34C (transitional provisions for coronavirus test devices) insert— Exemption for coronavirus test devices in conformity with Regulation (EU) 2017/746 and Regulation (EU) 2022/1107 34D. Regulation 34A does not apply in Northern Ireland— (a) in relation to a coronavirus test device that is in conformity with Regulation (EU) 2017/746 and the common specifications set out in Annex I and XIII to Regulation (EU) 2022/1107; (b) after 24 July 2024, in relation to a coronavirus test device that is in conformity with Regulation (EU) 2017/746. .
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