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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 26
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Amendment to the Market Surveillance (Northern Ireland) Regulations 2021
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26. In the Market Surveillance (Northern Ireland) Regulations 2021(1), Schedule 1(2) (investigatory powers) is amended as follows—
(a)in paragraph 1, after the definition of “Regulation (EU) 2017/745 on medical devices” insert—
““Regulation (EU) 2017/746 on in vitro diagnostic medical devices” means Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU.”;
(b)in paragraph 16—
(i)for sub-paragraph (2) substitute—
“(2) The officer may decommission or switch off any medical device to which the Medical Devices Regulations 2002, Regulation (EU) 2017/745 on medical devices or Regulation (EU) 2017/746 on in vitro diagnostic medical devices apply which is installed at a given location.”;
(ii)at the end of sub-paragraph (3)(a)(iv) omit “and” and insert—
“(v)Regulation (EU) 2017/746 on in vitro diagnostic medical devices; and”.
(1)
(2)
Schedule 1 was amended by S.I. 2021/905.
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