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The Medical Devices Regulations 2002, Section 3ZA is up to date with all changes known to be in force on or before 03 October 2024. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations.
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3ZA.—[F3(1) Subject to paragraph (2), Parts 2 to 7 only apply in Northern Ireland for the purpose of regulating qualifying devices.]
(2) The following provisions continue to apply in Northern Ireland in accordance with this paragraph F4...—
[F5(a)for the purposes of the registration of medical devices (whether or not they are qualifying devices) and persons placing medical devices on the market in Northern Ireland—
(i)regulation 19 (registration of persons placing general medical devices on the market),
(ii)regulation 21B (registration of persons placing active implantable medical devices on the market),
(iii)regulation 44 (registration of persons placing in vitro diagnostic medical devices on the market or for performance evaluation), and
(iv)regulation 53 (fees in connection with the registration of devices and changes to registration details),
only apply until the date which is 24 months after the date of publication of the notice referred to in Article 34(3) of Regulation (EU) 2017/745;
(aa)regulations 34A to 34D, 38A to 38C, 39A, 56A, 59 and 61 continue to apply in relation to coronavirus test devices whether or not they are qualifying devices;]
(b)Parts 5 to 7 [F6also] apply for purposes related to the designation of conformity assessment bodies for the purposes of a UK mutual recognition agreement.
(3) [F7For the purposes of this regulation], a device is a qualifying device if, by virtue of Article 120 of Regulation (EU) 2017/745 [F8or Article 110 of Regulation (EU) 2017/746]—
(a)it may be placed on the market, put into service or made available in Northern Ireland in accordance with the requirements of [F9Directive 90/385, Directive 93/42 or Directive 98/79, rather than Regulation (EU) 2017/745 or Regulation (EU) 2017/746; and]
(b)it is placed on the market, put into service or made available in Northern Ireland in accordance with, and subject to the requirements of and the arrangements set out in, Parts 2 F10... to 7.]
Textual Amendments
F1Reg. 3ZA inserted (N.I.) (27.7.2021) by The Medical Devices (Northern Ireland Protocol) Regulations 2021 (S.I. 2021/905), regs. 1(2), 32
F2Words in reg. 3ZA heading inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 12(a)
F3Reg. 3ZA(1) substituted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 12(b)
F4Words in reg. 3ZA(2) omitted (21.3.2024) by virtue of The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 12(c)(i)
F5Reg. 3ZA(2)(a)(aa) substituted for reg. 3ZA(2)(a) (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 12(c)(ii)
F6Word in reg. 3ZA(2)(b) inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 12(c)(iii)
F7Words in reg. 3ZA(3) substituted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 12(d)(i)
F8Words in reg. 3ZA(3) inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 12(d)(ii)
F9Words in reg. 3ZA(3)(a) substituted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 12(d)(iii)
F10Words in reg. 3ZA(3)(b) omitted (21.3.2024) by virtue of The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 12(d)(iv)
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