The agreement of an implementation period will mean that the Medicines and Healthcare products Regulatory Agency (MHRA) will continue to be recognised as a European Union competent authority designated under the EU Directives for medical devices, in vitro diagnostic medical devices and active implantable medical devices, during this period.<\/p>
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This is also the case for the new EU Regulations for medical devices and in vitro diagnostic medical devices, which both entered into force in May 2017.<\/p>
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It is possible for a single organisation to have individual notified bodies designated in more than one Member State. The authority within each Member State is responsible for notified bodies based in its own country.<\/p>
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The MHRA is responsible for the designation and monitoring of notified bodies in the United Kingdom, which the response to Question 196736 refers to.<\/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" : "2018-12-10", "_datatype" : "dateTime"} , "groupedQuestionUIN" : {"_value" : "199327"} , "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2018-12-10T14:12:25.46Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "17"} , "answeringDeptShortName" : {"_value" : "Health and Social Care"} , "answeringDeptSortName" : {"_value" : "Health and Social Care"} , "date" : {"_value" : "2018-12-05", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "Medicines and Healthcare products Regulatory Agency"} , "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, pursuant to the Answer of 03 December 2018 to Question 196736 on Medicines and Healthcare Products Regulatory Agency (MHRA), and with reference to the transition period set out in the Agreement on the Withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union, if the MHRA will be recognised as an EU competent authority under the EU (a) Medical Devices Directive, (b) in-vitro diagnostic medical devices, and (c) Medical Devices Regulation during the period covered by the Agreement.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/1436", "label" : {"_value" : "Biography information for Paul Farrelly"} } , "tablingMemberConstituency" : {"_value" : "Newcastle-under-Lyme"} , "tablingMemberPrinted" : [{"_value" : "Paul Farrelly"} ], "uin" : "199325"} ], "itemsPerPage" : 10, "page" : 0, "startIndex" : 1, "totalResults" : 1, "type" : ["http://purl.org/linked-data/api/vocab#ListEndpoint", "http://purl.org/linked-data/api/vocab#Page"]} }