New European Union Regulations for medical devices (MDR) entered into force in May 2017 and will fully apply from May 2020.<\/p>
The new Regulations substantially strengthen the regulatory framework for medical devices and notified bodies are having to make significant changes to meet the enhanced requirements. These changes have the aim of improving the quality, consistency and rigour of notified body assessments, which was one of the Government\u2019s key aims for the new legislation.<\/p>
Ministers have met with and received letters from industry representatives who have raised concerns about capacity in the notified body sector across the EU to support the implementation of the MDR. The Government recognises the importance of having competent notified bodies across the EU in place in sufficient time to ensure continuity of supply of products to the United Kingdom market.<\/p>
For this reason, at the Employment, Social Policy, Health and Consumer Affairs (EPSCO) Council on 14 June, the Parliamentary Under-Secretary of State (Baroness Blackwood of North Oxford) raised the Government\u2019s concerns about the readiness of critical infrastructure required to implement the MDR and the risk that some existing and new to market products will not be available to patients as a result.<\/p>
We very much recognise the benefits of the new Regulations and the imperative of full implementation as soon as possible in the interests of patient safety. Therefore, at EPSCO the Government emphasised the importance of finding a coordinated solution at an EU level and we will continue to do what we can to influence these discussions.<\/p>
In parallel with this activity, the Medicines and Healthcare products Regulatory Agency (MHRA) has been engaging with its notified bodies on an ongoing basis to ensure that sufficient resources are in place and notified bodies are prepared for the implementation of the new EU legislation. The MHRA is also offering a substantial amount of resource to the EU in order to support and expedite the designation process.<\/p>
Through the Office for Life Sciences, the Government plans to work with stakeholders to come to a shared understanding of the issues and discuss what further mitigating action could be taken. Further engagement with industry will therefore take place in the short term.<\/p>
<\/p>"} , "answeringMember" : {"_about" : "http://data.parliament.uk/members/4065", "label" : {"_value" : "Biography information for Dame Jackie Doyle-Price"} } , "answeringMemberConstituency" : {"_value" : "Thurrock"} , "answeringMemberPrinted" : {"_value" : "Jackie Doyle-Price"} , "dateOfAnswer" : {"_value" : "2019-07-25", "_datatype" : "dateTime"} , "groupedQuestionUIN" : [{"_value" : "277763"} , {"_value" : "277764"} ], "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2019-07-25T10:00:04.983Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "17"} , "answeringDeptShortName" : {"_value" : "Health and Social Care"} , "answeringDeptSortName" : {"_value" : "Health and Social Care"} , "date" : {"_value" : "2019-07-17", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "Medical Equipment: UK Notified Bodies"} , "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 assessment he has made of the adequacy of the number of notified bodies to service medical devices under the terms of the Medical Devices Regulation.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/4398", "label" : {"_value" : "Biography information for Chris Green"} } , "tablingMemberConstituency" : {"_value" : "Bolton West"} , "tablingMemberPrinted" : [{"_value" : "Chris Green"} ], "uin" : "278523"} , {"_about" : "http://data.parliament.uk/resources/1139219", "AnsweringBody" : [{"_value" : "Department of Health and Social Care"} ], "answer" : {"_about" : "http://data.parliament.uk/resources/1139219/answer", "answerText" : {"_value" : "
New European Union Regulations for medical devices (MDR) entered into force in May 2017 and will fully apply from May 2020.<\/p>
The new Regulations substantially strengthen the regulatory framework for medical devices and notified bodies are having to make significant changes to meet the enhanced requirements. These changes have the aim of improving the quality, consistency and rigour of notified body assessments, which was one of the Government\u2019s key aims for the new legislation.<\/p>
Ministers have met with and received letters from industry representatives who have raised concerns about capacity in the notified body sector across the EU to support the implementation of the MDR. The Government recognises the importance of having competent notified bodies across the EU in place in sufficient time to ensure continuity of supply of products to the United Kingdom market.<\/p>
For this reason, at the Employment, Social Policy, Health and Consumer Affairs (EPSCO) Council on 14 June, the Parliamentary Under-Secretary of State (Baroness Blackwood of North Oxford) raised the Government\u2019s concerns about the readiness of critical infrastructure required to implement the MDR and the risk that some existing and new to market products will not be available to patients as a result.<\/p>
We very much recognise the benefits of the new Regulations and the imperative of full implementation as soon as possible in the interests of patient safety. Therefore, at EPSCO the Government emphasised the importance of finding a coordinated solution at an EU level and we will continue to do what we can to influence these discussions.<\/p>
In parallel with this activity, the Medicines and Healthcare products Regulatory Agency (MHRA) has been engaging with its notified bodies on an ongoing basis to ensure that sufficient resources are in place and notified bodies are prepared for the implementation of the new EU legislation. The MHRA is also offering a substantial amount of resource to the EU in order to support and expedite the designation process.<\/p>
Through the Office for Life Sciences, the Government plans to work with stakeholders to come to a shared understanding of the issues and discuss what further mitigating action could be taken. Further engagement with industry will therefore take place in the short term.<\/p>
<\/p>"} , "answeringMember" : {"_about" : "http://data.parliament.uk/members/4065", "label" : {"_value" : "Biography information for Dame Jackie Doyle-Price"} } , "answeringMemberConstituency" : {"_value" : "Thurrock"} , "answeringMemberPrinted" : {"_value" : "Jackie Doyle-Price"} , "dateOfAnswer" : {"_value" : "2019-07-25", "_datatype" : "dateTime"} , "groupedQuestionUIN" : [{"_value" : "277764"} , {"_value" : "278523"} ], "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2019-07-25T10:00:04.89Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "17"} , "answeringDeptShortName" : {"_value" : "Health and Social Care"} , "answeringDeptSortName" : {"_value" : "Health and Social Care"} , "date" : {"_value" : "2019-07-16", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "Medical Equipment: UK Notified Bodies"} , "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 recent representations he has received from the medical technology sector on the capacity of Notified Bodies to meet the demand for their services under the provisions of the Medical Devices Regulation; and if he will make a statement.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/4398", "label" : {"_value" : "Biography information for Chris Green"} } , "tablingMemberConstituency" : {"_value" : "Bolton West"} , "tablingMemberPrinted" : [{"_value" : "Chris Green"} ], "uin" : "277763"} , {"_about" : "http://data.parliament.uk/resources/1139220", "AnsweringBody" : [{"_value" : "Department of Health and Social Care"} ], "answer" : {"_about" : "http://data.parliament.uk/resources/1139220/answer", "answerText" : {"_value" : "
New European Union Regulations for medical devices (MDR) entered into force in May 2017 and will fully apply from May 2020.<\/p>
The new Regulations substantially strengthen the regulatory framework for medical devices and notified bodies are having to make significant changes to meet the enhanced requirements. These changes have the aim of improving the quality, consistency and rigour of notified body assessments, which was one of the Government\u2019s key aims for the new legislation.<\/p>
Ministers have met with and received letters from industry representatives who have raised concerns about capacity in the notified body sector across the EU to support the implementation of the MDR. The Government recognises the importance of having competent notified bodies across the EU in place in sufficient time to ensure continuity of supply of products to the United Kingdom market.<\/p>
For this reason, at the Employment, Social Policy, Health and Consumer Affairs (EPSCO) Council on 14 June, the Parliamentary Under-Secretary of State (Baroness Blackwood of North Oxford) raised the Government\u2019s concerns about the readiness of critical infrastructure required to implement the MDR and the risk that some existing and new to market products will not be available to patients as a result.<\/p>
We very much recognise the benefits of the new Regulations and the imperative of full implementation as soon as possible in the interests of patient safety. Therefore, at EPSCO the Government emphasised the importance of finding a coordinated solution at an EU level and we will continue to do what we can to influence these discussions.<\/p>
In parallel with this activity, the Medicines and Healthcare products Regulatory Agency (MHRA) has been engaging with its notified bodies on an ongoing basis to ensure that sufficient resources are in place and notified bodies are prepared for the implementation of the new EU legislation. The MHRA is also offering a substantial amount of resource to the EU in order to support and expedite the designation process.<\/p>
Through the Office for Life Sciences, the Government plans to work with stakeholders to come to a shared understanding of the issues and discuss what further mitigating action could be taken. Further engagement with industry will therefore take place in the short term.<\/p>
<\/p>"} , "answeringMember" : {"_about" : "http://data.parliament.uk/members/4065", "label" : {"_value" : "Biography information for Dame Jackie Doyle-Price"} } , "answeringMemberConstituency" : {"_value" : "Thurrock"} , "answeringMemberPrinted" : {"_value" : "Jackie Doyle-Price"} , "dateOfAnswer" : {"_value" : "2019-07-25", "_datatype" : "dateTime"} , "groupedQuestionUIN" : [{"_value" : "277763"} , {"_value" : "278523"} ], "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2019-07-25T10:00:04.937Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "17"} , "answeringDeptShortName" : {"_value" : "Health and Social Care"} , "answeringDeptSortName" : {"_value" : "Health and Social Care"} , "date" : {"_value" : "2019-07-16", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "Medical Devices (Amendment etc.) (EU Exit) Regulations 2019"} , "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, whether he plans to seek an extension to the implementation period of the Medical Devices Regulation from the EU.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/4398", "label" : {"_value" : "Biography information for Chris Green"} } , "tablingMemberConstituency" : {"_value" : "Bolton West"} , "tablingMemberPrinted" : [{"_value" : "Chris Green"} ], "uin" : "277764"} , {"_about" : "http://data.parliament.uk/resources/1138235", "AnsweringBody" : [{"_value" : "Department of Health and Social Care"} ], "answer" : {"_about" : "http://data.parliament.uk/resources/1138235/answer", "answerText" : {"_value" : "
As for all NHS England campaigns, the adequacy of the funding for the \u2018NHS Help Us Help You Winter Pressures\u2019 campaign is measured by the effectiveness of the campaign in achieving it objectives, which are set.<\/p>
The independent evaluation research showed that the 2018/19 \u2018NHS Help Us Help You Winter Pressures\u2019 campaign successfully achieved 15 of the 18 objectives set before the activity started. The \u2018NHS Help Us Help You Winter Pressures\u2019 campaign budget for 2019/20 has been reduced by 7.5% when compared to the budget for 2018/19. However, NHS England expects to deliver similar levels of effectiveness.<\/p>
<\/p>
<\/p>
<\/strong><\/p>"}
, "answeringMember" : {"_about" : "http://data.parliament.uk/members/1585", "label" : {"_value" : "Biography information for Stephen Hammond"}
}
, "answeringMemberConstituency" : {"_value" : "Wimbledon"}
, "answeringMemberPrinted" : {"_value" : "Stephen Hammond"}
, "dateOfAnswer" : {"_value" : "2019-07-16", "_datatype" : "dateTime"}
, "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"}
, "questionFirstAnswered" : [{"_value" : "2019-07-16T16:08:01.02Z", "_datatype" : "dateTime"}
]}
, "answeringDeptId" : {"_value" : "17"}
, "answeringDeptShortName" : {"_value" : "Health and Social Care"}
, "answeringDeptSortName" : {"_value" : "Health and Social Care"}
, "date" : {"_value" : "2019-07-10", "_datatype" : "dateTime"}
, "hansardHeading" : {"_value" : "Weather: Health Education"}
, "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 assessment his Department has made of the adequacy of the funding allocated to the NHS Help us help you to stay well this winter campaign in the (a) last and (b) next 12 months.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"}
, "tablingMember" : {"_about" : "http://data.parliament.uk/members/4398", "label" : {"_value" : "Biography information for Chris Green"}
}
, "tablingMemberConstituency" : {"_value" : "Bolton West"}
, "tablingMemberPrinted" : [{"_value" : "Chris Green"}
], "uin" : "275776"}
, {"_about" : "http://data.parliament.uk/resources/1138237", "AnsweringBody" : [{"_value" : "Department of Health and Social Care"}
], "answer" : {"_about" : "http://data.parliament.uk/resources/1138237/answer", "answerText" : {"_value" : " Public Health England is planning to spend £1,300,000 on a flu vaccination campaign to encourage eligible members of the public and health and social care workers to take up the free vaccine ahead of the winter season. The spend includes expenditure for advertising on television, radio, national and regional press, outdoor, digital, and printing, excluding VAT. Figures provided are provisional and need to be reconciled following the campaign\u2019s conclusion in November.<\/p> Flu marketing resources can be viewed at following link:<\/p>