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The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024

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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”.

(2)

Schedule 1 was amended by S.I. 2021/905.

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