There are currently four United Kingdom-based notified bodies designated under the Directive 93/42/EC on medical devices and Directive 98/79/EC on in vitro diagnostic medical devices. Of these four UK notified bodies, one is also designated Directive 90/385/EEC on active implantable medical devices. The Medicines and Healthcare products Regulatory Agency (MHRA) is the designating authority in the UK and is responsible for designating and monitoring the performance of UK notified bodies. This includes undertaking regular audits of their activities.<\/p>
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New European Union Regulations for medical devices (Regulation 2017/745) and in vitro diagnostic medical devices (Regulation 2017/746) entered into force in May 2017, with Regulation 2017/745 fully applying from May 2020 and Regulation 2017/746 fully applying from May 2022. Each notified body will need to apply for separate designation under these Regulations. No notified body in the UK, or across the EU, is currently designated under either Regulation.<\/p>
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The new Regulations substantially strengthen the regulatory framework for medical devices and in vitro diagnostic devices and the MHRA recognises the importance of having competent notified bodies in place in sufficient time to ensure continuity of supply of products to the UK market.<\/p>
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To this end, the MHRA has been engaging with UK notified bodies on an ongoing basis to ensure that sufficient resources are in place and to ensure notified bodies are prepared for the designation process. The MHRA is also providing expert auditors to support the process of joint assessment of notified bodies under the new legislation across the EU to support the consistent application of the new Regulations across all EU Member States.<\/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" : "2018-12-04", "_datatype" : "dateTime"} , "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2018-12-04T17:25:31.587Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "17"} , "answeringDeptShortName" : {"_value" : "Health and Social Care"} , "answeringDeptSortName" : {"_value" : "Health and Social Care"} , "date" : {"_value" : "2018-11-29", "_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, how many UK-based notified bodies for medical devices have registered under the EU Medical Devices Regulations 2017; how many of those bodies were registered under previous regulations; what assessment he has made of the effect on the NHS in the event that insufficient notified bodies register; and if he will make a statement.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/1490", "label" : {"_value" : "Biography information for Mrs Madeleine Moon"} } , "tablingMemberConstituency" : {"_value" : "Bridgend"} , "tablingMemberPrinted" : [{"_value" : "Mrs Madeleine Moon"} ], "uin" : "197371"} , {"_about" : "http://data.parliament.uk/resources/1017202", "AnsweringBody" : [{"_value" : "Department for Environment, Food and Rural Affairs"} ], "answer" : {"_about" : "http://data.parliament.uk/resources/1017202/answer", "answerText" : {"_value" : "
To provide continuity for businesses in a no deal scenario, the EU Withdrawal Act copies EU legislation into UK law, including REACH, as far as possible. This means that the requirements established through these regulations will continue to apply in the UK. This includes retaining all exemptions that remain applicable, including chemicals used in medical products or equipment. By doing this we would minimise disruption to the supply in chemicals.<\/p>
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While it would not be appropriate to pre-judge the outcome of negotiations regarding the Future Economic Partnership, we will discuss with the EU and Member States how best to continue cooperation in chemicals regulation in the best interests of both the UK and the EU.<\/p>"} , "answeringMember" : {"_about" : "http://data.parliament.uk/members/4098", "label" : {"_value" : "Biography information for Dr Thérèse Coffey"} } , "answeringMemberConstituency" : {"_value" : "Suffolk Coastal"} , "answeringMemberPrinted" : {"_value" : "Dr Thérèse Coffey"} , "dateOfAnswer" : {"_value" : "2018-12-04", "_datatype" : "dateTime"} , "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2018-12-04T16:40:38.157Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "13"} , "answeringDeptShortName" : {"_value" : "Environment, Food and Rural Affairs"} , "answeringDeptSortName" : {"_value" : "Environment, Food and Rural Affairs"} , "date" : {"_value" : "2018-11-29", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "Medical Equipment: Cobalt"} , "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 assessment he has made of the potential effect on the operation of the UK-EU medical devices supply chain of the ongoing use of cobalt in UK-manufactured medical devices in the event that the UK is no longer subject to EU REACH regulations; and if he will make a statement.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/1490", "label" : {"_value" : "Biography information for Mrs Madeleine Moon"} } , "tablingMemberConstituency" : {"_value" : "Bridgend"} , "tablingMemberPrinted" : [{"_value" : "Mrs Madeleine Moon"} ], "uin" : "197372"} , {"_about" : "http://data.parliament.uk/resources/1017203", "AnsweringBody" : [{"_value" : "Department of Health and Social Care"} ], "answer" : {"_about" : "http://data.parliament.uk/resources/1017203/answer", "answerText" : {"_value" : "
The Government is working to mitigate the impact of any potential delays at borders in the unlikely event of a no-deal outcome to our negotiations on exiting the European Union. Our planning aims to ensure that from the day the United Kingdom leaves the EU, we will have the necessary resources and contingencies in place to maintain uninterrupted supplies of medical devices, including those delivered to National Health Service trusts on a just in time basis.<\/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" : "2018-12-06", "_datatype" : "dateTime"} , "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2018-12-06T10:35:17.77Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "17"} , "answeringDeptShortName" : {"_value" : "Health and Social Care"} , "answeringDeptSortName" : {"_value" : "Health and Social Care"} , "date" : {"_value" : "2018-11-29", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "Medical Equipment"} , "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 effect on just in time delivery arrangements for medical devices of the UK leaving the EU Customs Union; and if he will make a statement.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/1490", "label" : {"_value" : "Biography information for Mrs Madeleine Moon"} } , "tablingMemberConstituency" : {"_value" : "Bridgend"} , "tablingMemberPrinted" : [{"_value" : "Mrs Madeleine Moon"} ], "uin" : "197373"} , {"_about" : "http://data.parliament.uk/resources/1017204", "AnsweringBody" : [{"_value" : "Department for Digital, Culture, Media and Sport"} ], "answer" : {"_about" : "http://data.parliament.uk/resources/1017204/answer", "answerText" : {"_value" : "
The Secretary of State for Digital, Culture, Media and Sport has regular meetings with Ofcom as part of normal government business. The Government recognises the value and importance of high quality public service content and the need for this to be widely accessible to viewers. That is why under the Digital Economy Act 2017, the government required Ofcom to publish a report which looks at the ease of finding PSB content across all platforms. Ofcom\u2019s consultation on proposed changes to the linear EPG Code and the future of the prominence regime closed in October and the government looks forward to the publication of its findings.<\/p>"} , "answeringMember" : {"_about" : "http://data.parliament.uk/members/4115", "label" : {"_value" : "Biography information for Margot James"} } , "answeringMemberConstituency" : {"_value" : "Stourbridge"} , "answeringMemberPrinted" : {"_value" : "Margot James"} , "dateOfAnswer" : {"_value" : "2018-12-04", "_datatype" : "dateTime"} , "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2018-12-04T17:30:16.617Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "10"} , "answeringDeptShortName" : {"_value" : "Digital, Culture, Media and Sport"} , "answeringDeptSortName" : {"_value" : "Digital, Culture, Media and Sport"} , "date" : {"_value" : "2018-11-29", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "Electronic Programme Guides: Public Service Broadcasting"} , "houseId" : {"_value" : "1"} , "legislature" : [{"_about" : "http://data.parliament.uk/terms/25259", "prefLabel" : {"_value" : "House of Commons"} } ], "questionText" : "To ask the Secretary of State for Digital, Culture, Media and Sport, what recent discussions has he had with Ofcom on ensuring that public service broadcasters retain a prominent position in electronic programming guides.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/3999", "label" : {"_value" : "Biography information for Graham P Jones"} } , "tablingMemberConstituency" : {"_value" : "Hyndburn"} , "tablingMemberPrinted" : [{"_value" : "Graham P Jones"} ], "uin" : "197374"} , {"_about" : "http://data.parliament.uk/resources/1017205", "AnsweringBody" : [{"_value" : "Treasury"} ], "answer" : {"_about" : "http://data.parliament.uk/resources/1017205/answer", "answerText" : {"_value" : "
For 2015-2016, the most recent year for which data is available, 572,000 non-UK EU nationals were in receipt of Child Benefit and total entitlement for these non-UK EU nationals was £879 million.<\/p>
<\/p>
The number of non-UK EU nationals expected to be living in the UK over the next 15 years that qualify for Child Benefit could only be provided at disproportionate cost.<\/p>
<\/p>
Information relating to the number and cost of non-UK EU nationals claiming for children who are and are not resident in the UK can only be made available at disproportionate cost.<\/p>"} , "answeringMember" : {"_about" : "http://data.parliament.uk/members/4097", "label" : {"_value" : "Biography information for Elizabeth Truss"} } , "answeringMemberConstituency" : {"_value" : "South West Norfolk"} , "answeringMemberPrinted" : {"_value" : "Elizabeth Truss"} , "dateOfAnswer" : {"_value" : "2018-12-04", "_datatype" : "dateTime"} , "groupedQuestionUIN" : {"_value" : "197370"} , "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2018-12-04T15:29:51.277Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "14"} , "answeringDeptShortName" : {"_value" : "Treasury"} , "answeringDeptSortName" : {"_value" : "Treasury"} , "date" : {"_value" : "2018-11-29", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "Child Benefit: EU Nationals"} , "houseId" : {"_value" : "1"} , "legislature" : [{"_about" : "http://data.parliament.uk/terms/25259", "prefLabel" : {"_value" : "House of Commons"} } ], "questionText" : "To ask the Chancellor of the Exchequer, how many non-UK EU nationals living in the UK that are in receipt of child benefit have children that (a) are and (b) are not resident in the UK; and what estimate he has made of the cost to the public purse of those claims.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/4066", "label" : {"_value" : "Biography information for Priti Patel"} } , "tablingMemberConstituency" : {"_value" : "Witham"} , "tablingMemberPrinted" : [{"_value" : "Priti Patel"} ], "uin" : "197375"} , {"_about" : "http://data.parliament.uk/resources/1017206", "AnsweringBody" : [{"_value" : "Department for Work and Pensions"} ], "answer" : {"_about" : "http://data.parliament.uk/resources/1017206/answer", "answerText" : {"_value" : "