All medical devices placed on the United Kingdom market must comply with the European Union Medical Devices Directive 93/42/EEC (MDD). The European Conformity (CE) mark for a device is placed on a product by a manufacturer to attest to its compliance with the safety, quality and performance requirements of the MDD.<\/p>
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For higher risk devices, including hip replacement implants, manufacturers must have the product\u2019s safety and performance assessed by an independent certification body, called a notified body, before the CE mark can be affixed.<\/p>
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A notified body\u2019s tasks will vary depending on the classification of the products concerned, but typical activities include an examination of the design dossier relating to each type of product, an assessment of the full technical information, and manufacturer inspections. Under the MDD, manufacturers are required to have clinical and safety data to support their performance claims for the device, which is also assessed by the notified body.<\/p>
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Once a device is placed on the market, the manufacturer is required to continually monitor the performance of their device, submit vigilance reports to the Medicines and Healthcare products Regulatory Agency (MHRA) when incidents occur involving their device and take appropriate safety action when required. Additionally, the MHRA monitors adverse incident reported though the Yellow Card reporting system. Adverse incident reports can be submitted to the MHRA by members of the public, healthcare professionals and the device manufacturer.<\/p>
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Furthermore, the new European Union Medical Devices Regulation 2017/745, which entered into force in May 2017, has introduced more stringent requirements from manufacturers to ensure a high level of patient safety. These include increased scrutiny by notified bodies, particularly for higher risk devices, new standards for clinical evidence and more rigorous vigilance reporting requirements.<\/p>"} , "answeringMember" : {"_about" : "http://data.parliament.uk/members/4070", "label" : {"_value" : "Biography information for Matt Hancock"} } , "answeringMemberConstituency" : {"_value" : "West Suffolk"} , "answeringMemberPrinted" : {"_value" : "Matt Hancock"} , "dateOfAnswer" : {"_value" : "2018-10-16", "_datatype" : "dateTime"} , "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2018-10-16T13:56:24.34Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "17"} , "answeringDeptShortName" : {"_value" : "Health and Social Care"} , "answeringDeptSortName" : {"_value" : "Health and Social Care"} , "date" : {"_value" : "2018-10-08", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "Hip Replacements: Safety"} , "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 his Department is taking to ensure that the (a) testing and (b) certification procedures for (i) metal and (ii) other compositions of hip replacements fitted as medical devices by the NHS ensure that such devices are safe for patients; and if he will make a statement.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/4605", "label" : {"_value" : "Biography information for Bill Grant"} } , "tablingMemberConstituency" : {"_value" : "Ayr, Carrick and Cumnock"} , "tablingMemberPrinted" : [{"_value" : "Bill Grant"} ], "uin" : "176549"} , {"_about" : "http://data.parliament.uk/resources/969449", "AnsweringBody" : [{"_value" : "Department for Business, Energy and Industrial Strategy"} ], "answer" : {"_about" : "http://data.parliament.uk/resources/969449/answer", "answerText" : {"_value" : "
The Government\u2019s Smart Meter Programme applies to all domestic consumers and small businesses, who do not currently pay these charges regardless of whether they have a smart meter. Currently only certain larger businesses or organisations pay capacity charges.<\/p>"} , "answeringMember" : {"_about" : "http://data.parliament.uk/members/3974", "label" : {"_value" : "Biography information for Claire Perry"} } , "answeringMemberConstituency" : {"_value" : "Devizes"} , "answeringMemberPrinted" : {"_value" : "Claire Perry"} , "dateOfAnswer" : {"_value" : "2018-09-17", "_datatype" : "dateTime"} , "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2018-09-17T15:22:55.083Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "201"} , "answeringDeptShortName" : {"_value" : "Business, Energy and Industrial Strategy"} , "answeringDeptSortName" : {"_value" : "Business, Energy and Industrial Strategy"} , "date" : {"_value" : "2018-09-07", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "Energy: Meters"} , "houseId" : {"_value" : "1"} , "legislature" : [{"_about" : "http://data.parliament.uk/terms/25259", "prefLabel" : {"_value" : "House of Commons"} } ], "questionText" : "To ask the Secretary of State for Business, Energy and Industrial Strategy, if he will make it his policy to introduce an exemption for charities from authorised supply capacity charges relating to smart meters.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/4605", "label" : {"_value" : "Biography information for Bill Grant"} } , "tablingMemberConstituency" : {"_value" : "Ayr, Carrick and Cumnock"} , "tablingMemberPrinted" : [{"_value" : "Bill Grant"} ], "uin" : "171723"} , {"_about" : "http://data.parliament.uk/resources/969501", "AnsweringBody" : [{"_value" : "Department for Environment, Food and Rural Affairs"} ], "answer" : {"_about" : "http://data.parliament.uk/resources/969501/answer", "answerText" : {"_value" : "
After leaving the EU, the UK will become an independent coastal state under international law (UN Convention on the Law of the Sea) and will have the right to control and manage access to fish in UK waters out to 200 nautical miles or the median line.<\/p>"} , "answeringMember" : {"_about" : "http://data.parliament.uk/members/3934", "label" : {"_value" : "Biography information for George Eustice"} } , "answeringMemberConstituency" : {"_value" : "Camborne and Redruth"} , "answeringMemberPrinted" : {"_value" : "George Eustice"} , "dateOfAnswer" : {"_value" : "2018-09-12", "_datatype" : "dateTime"} , "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2018-09-12T15:17:05.193Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "13"} , "answeringDeptShortName" : {"_value" : "Environment, Food and Rural Affairs"} , "answeringDeptSortName" : {"_value" : "Environment, Food and Rural Affairs"} , "date" : {"_value" : "2018-09-07", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "Fisheries"} , "houseId" : {"_value" : "1"} , "legislature" : [{"_about" : "http://data.parliament.uk/terms/25259", "prefLabel" : {"_value" : "House of Commons"} } ], "questionText" : "To ask the Secretary of State for Environment, Food and Rural Affairs, what steps he is taking to ensure that the UK has more control of its fishing waters after the UK leaves the EU.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/4605", "label" : {"_value" : "Biography information for Bill Grant"} } , "tablingMemberConstituency" : {"_value" : "Ayr, Carrick and Cumnock"} , "tablingMemberPrinted" : [{"_value" : "Bill Grant"} ], "uin" : "171724"} , {"_about" : "http://data.parliament.uk/resources/969093", "AnsweringBody" : [{"_value" : "Department for Transport"} ], "answer" : {"_about" : "http://data.parliament.uk/resources/969093/answer", "answerText" : {"_value" : "
Expansion at Heathrow is expected to deliver 100 additional flights to and from Scotland per week. Heathrow Airport Limited (HAL) believes that if it receives development consent by 2022, it will start construction soon after and that the new runway can be operational and in passenger use by 2026.<\/p>
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While the exact timing for the introduction of new flights will be for HAL and it partners determine, the Airports National Policy Statement requires HAL to work constructively with its airline customers to strengthen existing routes and develop new connections.<\/p>
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