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/1017222", "AnsweringBody" : [{"_value" : "Department for Business, Energy and Industrial Strategy"} ], "answer" : {"_about" : "http://data.parliament.uk/resources/1017222/answer", "answerText" : {"_value" : "
We have repeatedly stated our commitment to a far-reaching relationship with the EU on science and innovation. We have taken crucial first steps towards achieving this relationship by agreeing in principle the Withdrawal Agreement and Political Declaration. Once ratified, provisions in the Withdrawal Agreement will ensure continued UK participation in existing EU Programmes for their duration. Horizon 2020 is a current EU Programme.<\/p>
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We have also been clear that we would like the option to associate to the next EU Research and Innovation Framework Programme, Horizon Europe. The Political Declaration represents an important milestone by explicitly providing for the inclusion of terms for UK participation in Union programmes, such as science and innovation as part of a future UK-EU agreement.<\/p>
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In the unlikely event of no deal, the underwrite guarantee and extension would ensure continued UK participation in Horizon 2020 post-EU Exit. In this scenario, UK entities would be eligible to participate in and lead consortia in a wide range of collaborative programmes. We are seeking to discuss the details of our continued participation as a Third Country with the European Commission.<\/p>
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Whilst the UK remains a Member State, we continue to play an active role in the development of EU programmes, engaging with our counterparts in the European, Commission, Council and Parliament to ensure these remain attractive to international partners.<\/p>
<\/p>"} , "answeringMember" : {"_about" : "http://data.parliament.uk/members/4068", "label" : {"_value" : "Biography information for Lord Harrington of Watford"} } , "answeringMemberConstituency" : {"_value" : "Watford"} , "answeringMemberPrinted" : {"_value" : "Richard Harrington"} , "dateOfAnswer" : {"_value" : "2018-12-04", "_datatype" : "dateTime"} , "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2018-12-04T15:21:54.913Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "201"} , "answeringDeptShortName" : {"_value" : "Business, Energy and Industrial Strategy"} , "answeringDeptSortName" : {"_value" : "Business, Energy and Industrial Strategy"} , "date" : {"_value" : "2018-11-29", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "Universities: Research"} , "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, what recent steps his Department has taken to ensure that universities have access to EU research programmes after the UK leaves the EU.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/4510", "label" : {"_value" : "Biography information for Helen Hayes"} } , "tablingMemberConstituency" : {"_value" : "Dulwich and West Norwood"} , "tablingMemberPrinted" : [{"_value" : "Helen Hayes"} ], "uin" : "197465"} , {"_about" : "http://data.parliament.uk/resources/1017257", "AnsweringBody" : [{"_value" : "Department for Exiting the European Union "} ], "answer" : {"_about" : "http://data.parliament.uk/resources/1017257/answer", "answerText" : {"_value" : "
The UK has not agreed that Gibraltar will be excluded from the territorial scope of the future relationship between the EU and the UK. The UK, in a letter to the EU Council, and the Council, in the minutes of the Special November Council, set out their shared interpretation that Article 184 of the Withdrawal Agreement, which concerns the UK and the EU\u2019s future relationship, imposes no obligations regarding the territorial scope of future agreements. The UK also made clear we will only agree a deal on the future which works for the whole UK family and we will negotiate a deal that works for Gibraltar.<\/p>
The Article 50 Council guidelines are an internal matter for the Council in Article 50 format. Statements or actions by the EU institutions or other member states have no effect on the United Kingdom\u2019s sovereignty over Gibraltar.<\/p>
On Gibraltar, we have worked constructively with both the EU and the Government of Gibraltar throughout the process of agreeing the Withdrawal Agreement. We have ensured that Gibraltar is covered by both the Withdrawal Agreement and by the Implementation Period. We look forward to taking a similar approach for the future.<\/p>
<\/p>"} , "answeringMember" : {"_about" : "http://data.parliament.uk/members/4091", "label" : {"_value" : "Biography information for Mr Robin Walker"} } , "answeringMemberConstituency" : {"_value" : "Worcester"} , "answeringMemberPrinted" : {"_value" : "Mr Robin Walker"} , "dateOfAnswer" : {"_value" : "2018-12-10", "_datatype" : "dateTime"} , "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2018-12-10T15:39:32.947Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "203"} , "answeringDeptShortName" : {"_value" : "Exiting the European Union "} , "answeringDeptSortName" : {"_value" : "Exiting the European Union "} , "date" : {"_value" : "2018-11-29", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "Gibraltar"} , "houseId" : {"_value" : "1"} , "legislature" : [{"_about" : "http://data.parliament.uk/terms/25259", "prefLabel" : {"_value" : "House of Commons"} } ], "questionText" : "To ask the Secretary of State for Exiting the European Union, whether the recent statement he agreed with the President of the European Commission and President of the European Council, that Gibraltar will not be included in the territorial scope of agreement to be concluded between the EU and the UK (a) replaces or (b) amends the provisions of Article 24 of the Article 50 guidelines which provided for the application to Gibraltar of agreement between the EU and the UK after the UK leaves the EU; and will he make a statement.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/484", "label" : {"_value" : "Biography information for Dame Louise Ellman"} } , "tablingMemberConstituency" : {"_value" : "Liverpool, Riverside"} , "tablingMemberPrinted" : [{"_value" : "Dame Louise Ellman"} ], "uin" : "197346"} , {"_about" : "http://data.parliament.uk/resources/1017343", "AnsweringBody" : [{"_value" : "House of Commons Commission"} ], "answer" : {"_about" : "http://data.parliament.uk/resources/1017343/answer", "answerText" : {"_value" : "
Fire evacuation drills of the parliamentary estate are planned on an annual basis and the Chamber of the House of Commons was included as part of the last evacuation drill of the Palace of Westminster as a whole on 21 May 2018. Dates and time of fire evacuation drills are subject to change only for essential House business or security considerations.<\/p>"} , "answeringMember" : {"_about" : "http://data.parliament.uk/members/151", "label" : {"_value" : "Biography information for Tom Brake"} } , "answeringMemberConstituency" : {"_value" : "Carshalton and Wallington"} , "answeringMemberPrinted" : {"_value" : "Tom Brake"} , "dateOfAnswer" : {"_value" : "2018-12-13", "_datatype" : "dateTime"} , "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "previousAnswerVersion" : {"_about" : "http://data.parliament.uk/resources/1017343/answer/previousversion/90661", "answeringMember" : {"_about" : "http://data.parliament.uk/members/151", "label" : {"_value" : "Biography information for Tom Brake"} } , "answeringMemberConstituency" : {"_value" : "Carshalton and Wallington"} , "answeringMemberPrinted" : {"_value" : "Tom Brake"} } , "questionFirstAnswered" : [{"_value" : "2018-12-13T12:13:17.327Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "18"} , "answeringDeptShortName" : {"_value" : "House of Commons Commission"} , "answeringDeptSortName" : {"_value" : "House of Commons Commission"} , "date" : {"_value" : "2018-11-29", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "House of Commons Chamber: Fire Prevention"} , "houseId" : {"_value" : "1"} , "legislature" : [{"_about" : "http://data.parliament.uk/terms/25259", "prefLabel" : {"_value" : "House of Commons"} } ], "questionText" : "To ask the right hon. Member for Carshalton and Wallington, representing the House of Commons Commission, the last occasion on which a fire evacuation drill was conducted in the Chamber of the House of Commons; and whether he plans to conduct such a drill in future.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/1541", "label" : {"_value" : "Biography information for Dame Nia Griffith"} } , "tablingMemberConstituency" : {"_value" : "Llanelli"} , "tablingMemberPrinted" : [{"_value" : "Nia Griffith"} ], "uin" : "197454"} ], "itemsPerPage" : 10, "page" : 0, "startIndex" : 1, "totalResults" : 4, "type" : ["http://purl.org/linked-data/api/vocab#ListEndpoint", "http://purl.org/linked-data/api/vocab#Page"]} }