The Medicines and Healthcare products Regulatory Agency (MHRA) are unable to intervene in issues relating to capacity in the EU system. However, the MHRA recognises that there is a need to increase Approved Body capacity to ensure the continued supply of imported medical devices and equipment to the UK market by reducing regulatory barriers for companies and healthcare providers importing said devices. The MHRA are engaging with, reviewing applications from and auditing a number of organisations who have applied to be designated as a UK Approved Body. The MHRA is taking a pragmatic approach to the designation of these Approved Bodies, balancing the need to establish an independent UK system against avoiding any unnecessary duplication<\/p>
On the 25th<\/sup> October 2022, the MHRA announced that there will be a 12-month extension to the implementation of new UK Medical Device Regulations to accommodate for any disruption caused by the Great Britain\u2019s departure from the European Union. Manufacturers will be able to continue to place CE marked devices on the Great Britain market after 1 July 2023. Following this, from July 2024 the transitional arrangements will apply for CE and UKCA marked devices placed on the Great Britain market. Manufacturers are also able to apply to the MHRA for an Exceptional Use Authorisation (EUA) which permits the supply of a medical device without a valid CE or UKCA mark in certain circumstances.<\/p> In addition to building Approved Body capacity and extending the implementation of the revised UK regulations, the MHRA is working, with industry partners and designated Approved Bodies, to assess what further actions can be taken to ensure ongoing supply of medical devices where manufacturers have been unable to secure ongoing certification.<\/p>"}
, "answeringMember" : {"_about" : "http://data.parliament.uk/members/4423", "label" : {"_value" : "Biography information for Will Quince"}
}
, "answeringMemberConstituency" : {"_value" : "Colchester"}
, "answeringMemberPrinted" : {"_value" : "Will Quince"}
, "dateOfAnswer" : {"_value" : "2023-02-02", "_datatype" : "dateTime"}
, "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"}
, "questionFirstAnswered" : [{"_value" : "2023-02-02T13:14:34.287Z", "_datatype" : "dateTime"}
]}
, "answeringDeptId" : {"_value" : "17"}
, "answeringDeptShortName" : {"_value" : "Health and Social Care"}
, "answeringDeptSortName" : {"_value" : "Health and Social Care"}
, "date" : {"_value" : "2023-01-24", "_datatype" : "dateTime"}
, "hansardHeading" : {"_value" : "Medical Equipment: Import Controls"}
, "houseId" : {"_value" : "1"}
, "legislature" : [{"_about" : "http://data.parliament.uk/terms/25259", "prefLabel" : {"_value" : "House of Commons"}
}
], "questionText" : "To ask the Secretary of State for Health and Social Care, what steps he is taking to help reduce regulatory barriers for companies and healthcare providers importing medical devices and equipment from the European Union.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"}
, "tablingMember" : {"_about" : "http://data.parliament.uk/members/4433", "label" : {"_value" : "Biography information for Thangam Debbonaire"}
}
, "tablingMemberConstituency" : {"_value" : "Bristol West"}
, "tablingMemberPrinted" : [{"_value" : "Thangam Debbonaire"}
], "uin" : "131226"}
, {"_about" : "http://data.parliament.uk/resources/1436490", "AnsweringBody" : [{"_value" : "Ministry of Defence"}
], "answer" : {"_about" : "http://data.parliament.uk/resources/1436490/answer", "answerText" : {"_value" : " Her Majesty's Government's humanitarian response to the war is being led by the Foreign Commonwealth and Development Office, who are working alongside aid agencies and non-governmental organisations. The Ministry of Defence is not providing food and medical supplies to neighbouring countries but has1,000 Service personnel on standby to deploy as required in response to a humanitarian crisis in Eastern Europe. The Department has also provided medical supplies to the Ukraine Armed Forces.<\/p>"}
, "answeringMember" : {"_about" : "http://data.parliament.uk/members/4528", "label" : {"_value" : "Biography information for James Heappey"}
}
, "answeringMemberConstituency" : {"_value" : "Wells"}
, "answeringMemberPrinted" : {"_value" : "James Heappey"}
, "dateOfAnswer" : {"_value" : "2022-03-14", "_datatype" : "dateTime"}
, "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"}
, "previousAnswerVersion" : {"_about" : "http://data.parliament.uk/resources/1436490/answer/previousversion/56183", "answeringMember" : {"_about" : "http://data.parliament.uk/members/4528", "label" : {"_value" : "Biography information for James Heappey"}
}
, "answeringMemberConstituency" : {"_value" : "Wells"}
, "answeringMemberPrinted" : {"_value" : "James Heappey"}
}
, "questionFirstAnswered" : [{"_value" : "2022-03-14T14:55:40.34Z", "_datatype" : "dateTime"}
]}
, "answeringDeptId" : {"_value" : "11"}
, "answeringDeptShortName" : {"_value" : "Defence"}
, "answeringDeptSortName" : {"_value" : "Defence"}
, "date" : {"_value" : "2022-02-28", "_datatype" : "dateTime"}
, "hansardHeading" : {"_value" : "Ukraine: Humanitarian Aid"}
, "houseId" : {"_value" : "1"}
, "legislature" : [{"_about" : "http://data.parliament.uk/terms/25259", "prefLabel" : {"_value" : "House of Commons"}
}
], "questionText" : "To ask the Secretary of State for Defence, if he will take steps to help ensure that food and medical supplies are available in neighbouring countries to that of Ukraine.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"}
, "tablingMember" : {"_about" : "http://data.parliament.uk/members/4471", "label" : {"_value" : "Biography information for Rachael Maskell"}
}
, "tablingMemberConstituency" : {"_value" : "York Central"}
, "tablingMemberPrinted" : [{"_value" : "Rachael Maskell"}
], "uin" : "131226"}
, {"_about" : "http://data.parliament.uk/resources/1272240", "AnsweringBody" : [{"_value" : "Home Office"}
], "answer" : {"_about" : "http://data.parliament.uk/resources/1272240/answer", "answerText" : {"_value" : " The Government remains committed to protecting vulnerable people and has acted decisively to ensure that we support everyone through this pandemic. During this time the Home Office has continued to work closely with Public Health Officials, Ministry of Housing, Communities and Local Government, and local authorities.<\/p> <\/p> The Government has introduced a range of measures to ensure people can stay safe and many of these such as the Coronavirus Job retention scheme, and self-employment income support scheme are available for those with a no recourse to public funds (NRPF) condition. Contribution-based benefits are also not classed as public funds for immigration purposes. Testing and treatment for Covid-19 is also free of charge to all regardless of immigration status.<\/p> <\/p> We have also launched the Test and Trace Support Payment scheme in England, which provides a £500 payment to people on low incomes who cannot work from home and have been told to self-isolate by NHS Test and Trace. Support is also available for those who are not in receipt of one of the seven means-tested benefits that are part of the eligibility criteria for the main scheme, but who will still face hardship if they have to self-isolate, in the form of a £500 discretionary payment, paid by local authorities. This payment is available to those with NRPF, provided they meet the criteria set by the local authority for discretionary payments in their area. Further information on this scheme can be found at https://www.gov.uk/government/publications/test-and-trace-support-payment-scheme-claiming-financial-support/claiming-financial-support-under-the-test-and-trace-support-payment-scheme<\/a><\/p> <\/p> The Government has provided an unprecedented £7.2 billion of package of support to councils to help their communities through this pandemic, which includes their work to support rough sleepers<\/em>. This includes £4.6 billion in un-ringfenced funding, £1.1 billion from the Infection Control Fund, £300 million to support Test and Trace as well as funding allocated to councils from the new Local Alert Level system and a number of grants to support communities and vulnerable people.<\/p> <\/p> Migrants with leave under the Family and Human Rights routes can apply to have their NRPF condition lifted by making a \u2018change of conditions\u2019 application if they are destitute or at risk of destitution, if the welfare of their child is at risk due to their low income Since the onset of the pandemic, we have continued to prioritise NRPF \u2018change of conditions\u2019 applications and deal with them compassionately.<\/p> In light of\u202fall the support that is\u202fcurrently\u202favailable for\u202fpeople in the UK, including those with an NRPF condition, we have no plans\u202fto temporarily suspend NRPF.<\/p>"}
, "answeringMember" : {"_about" : "http://data.parliament.uk/members/4503", "label" : {"_value" : "Biography information for Chris Philp"}
}
, "answeringMemberConstituency" : {"_value" : "Croydon South"}
, "answeringMemberPrinted" : {"_value" : "Chris Philp"}
, "dateOfAnswer" : {"_value" : "2021-01-11", "_datatype" : "dateTime"}
, "groupedQuestionUIN" : [{"_value" : "131224"}
, {"_value" : "131228"}
], "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"}
, "questionFirstAnswered" : [{"_value" : "2021-01-11T11:35:50.633Z", "_datatype" : "dateTime"}
]}
, "answeringDeptId" : {"_value" : "1"}
, "answeringDeptShortName" : {"_value" : "Home Office"}
, "answeringDeptSortName" : {"_value" : "Home Office"}
, "date" : {"_value" : "2020-12-17", "_datatype" : "dateTime"}
, "hansardHeading" : {"_value" : "Migrants: Coronavirus"}
, "houseId" : {"_value" : "1"}
, "legislature" : [{"_about" : "http://data.parliament.uk/terms/25259", "prefLabel" : {"_value" : "House of Commons"}
}
], "questionText" : "To ask the Secretary of State for the Home Department, what discussions she has had with (a) the Secretary of State for Housing, Community and Local Government and (b) the Secretary of State for Health and Social Care on the call from the Local Government Association to temporarily and universally remove the No Recourse to Public Funds condition to reduce public health risks and ease the pressure on homelessness services by enabling vulnerable people to access welfare benefits who are currently unable to do so because of their immigration status; and if she will make a statement.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"}
, "tablingMember" : {"_about" : "http://data.parliament.uk/members/3930", "label" : {"_value" : "Biography information for Caroline Lucas"}
}
, "tablingMemberConstituency" : {"_value" : "Brighton, Pavilion"}
, "tablingMemberPrinted" : [{"_value" : "Caroline Lucas"}
], "uin" : "131226"}
, {"_about" : "http://data.parliament.uk/resources/856060", "AnsweringBody" : [{"_value" : "Ministry of Justice"}
], "answer" : {"_about" : "http://data.parliament.uk/resources/856060/answer", "answerText" : {"_value" : " I can confirm that there have been no Incidents at HMP Bedford since January 2018 requiring a response from Tornado Teams.<\/p> We are currently considering proposals to publish information routinely on concerted indiscipline and incidents at height and will confirm such plans when a decision has been reached.<\/p>"}
, "answeringMember" : {"_about" : "http://data.parliament.uk/members/4137", "label" : {"_value" : "Biography information for Rory Stewart"}
}
, "answeringMemberConstituency" : {"_value" : "Penrith and The Border"}
, "answeringMemberPrinted" : {"_value" : "Rory Stewart"}
, "dateOfAnswer" : {"_value" : "2018-03-14", "_datatype" : "dateTime"}
, "groupedQuestionUIN" : [{"_value" : "131225"}
, {"_value" : "131234"}
], "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"}
, "questionFirstAnswered" : [{"_value" : "2018-03-14T17:04:47.91Z", "_datatype" : "dateTime"}
]}
, "answeringDeptId" : {"_value" : "54"}
, "answeringDeptShortName" : {"_value" : "Justice"}
, "answeringDeptSortName" : {"_value" : "Justice"}
, "date" : {"_value" : "2018-03-06", "_datatype" : "dateTime"}
, "hansardHeading" : {"_value" : "Bedford Prison"}
, "houseId" : {"_value" : "1"}
, "legislature" : [{"_about" : "http://data.parliament.uk/terms/25259", "prefLabel" : {"_value" : "House of Commons"}
}
], "questionText" : "To ask the Secretary of State for Justice, how many Incidents at height have occurred at HMP Bedford since 1 January 2018.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"}
, "tablingMember" : {"_about" : "http://data.parliament.uk/members/4493", "label" : {"_value" : "Biography information for Richard Burgon"}
}
, "tablingMemberConstituency" : {"_value" : "Leeds East"}
, "tablingMemberPrinted" : [{"_value" : "Richard Burgon"}
], "uin" : "131226"}
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}