The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024
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Change 1
26 Amendment to the Market Surveillance (Northern Ireland) Regulations 2021
In the Market Surveillance (Northern Ireland) Regulations 2021, Schedule 1 (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 .
26 Amendment to the Market Surveillance (Northern Ireland) Regulations 2021
In the Market Surveillance (Northern Ireland) Regulations 2021, Schedule 1 (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 .
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