The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024
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Change 1
3 Amendment to regulation 2 (interpretation)
In regulation 2(1)— (a) for the definition of “relevant essential requirements” substitute— “relevant essential requirements”— in Part 4A, has the meaning given in regulation 44ZC; in all other Parts, in relation to a medical device, means the essential requirements set out in Annex 1 of Directive 90/385, Annex I of Directive 93/42 or Annex I of Directive 98/79 which apply to it, but not including, in the case of a device intended for clinical investigation, such of those requirements, or aspects of them, as are the subject of the investigation; ; (b) for the definition of “Regulation (EU) No 722/2012” substitute— “Regulation (EU) No 722/2012”— in Part 4A, has the meaning given in regulation 44ZC; in all other Parts means Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin (as retained under section 3 of the European Union (Withdrawal) Act 2018 and modified under section 8 of that Act); ; (c) after the definition of “UK responsible person” insert— “working day” means any day which is not Saturday, Sunday, Christmas Day, Good Friday or a day which is a bank holiday in any part of Great Britain under the Banking and Financial Dealings Act 1971. .
3 Amendment to regulation 2 (interpretation)
In regulation 2(1)— (a) for the definition of “relevant essential requirements” substitute— “relevant essential requirements”— in Part 4A, has the meaning given in regulation 44ZC; in all other Parts, in relation to a medical device, means the essential requirements set out in Annex 1 of Directive 90/385, Annex I of Directive 93/42 or Annex I of Directive 98/79 which apply to it, but not including, in the case of a device intended for clinical investigation, such of those requirements, or aspects of them, as are the subject of the investigation; ; (b) for the definition of “Regulation (EU) No 722/2012” substitute— “Regulation (EU) No 722/2012”— in Part 4A, has the meaning given in regulation 44ZC; in all other Parts means Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin (as retained under section 3 of the European Union (Withdrawal) Act 2018 and modified under section 8 of that Act); ; (c) after the definition of “UK responsible person” insert— “working day” means any day which is not Saturday, Sunday, Christmas Day, Good Friday or a day which is a bank holiday in any part of Great Britain under the Banking and Financial Dealings Act 1971. .
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