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982917
unstar this property registered interest false more like this
star this property date less than 2018-10-08more like thismore than 2018-10-08
star this property answering body
Department of Health and Social Care more like this
star this property answering dept id 17 more like this
star this property answering dept short name Health and Social Care more like this
unstar this property answering dept sort name Health and Social Care remove filter
star this property hansard heading Hip Replacements: Safety more like this
star this property house id 1 more like this
star this property legislature
25259
star this property pref label House of Commons more like this
star this property question text 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. more like this
star this property tabling member constituency Ayr, Carrick and Cumnock more like this
star this property tabling member printed
Bill Grant more like this
star this property uin 176549 more like this
star this property answer
answer
unstar this property is ministerial correction false more like this
star this property date of answer less than 2018-10-16more like thismore than 2018-10-16
star this property answer text <p>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><p> </p><p>For higher risk devices, including hip replacement implants, manufacturers must have the product’s safety and performance assessed by an independent certification body, called a notified body, before the CE mark can be affixed.</p><p> </p><p>A notified body’s 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><p> </p><p>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><p> </p><p>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>
star this property answering member constituency West Suffolk more like this
star this property answering member printed Matt Hancock more like this
star this property question first answered
less than 2018-10-16T13:56:24.34Zmore like thismore than 2018-10-16T13:56:24.34Z
star this property answering member
4070
star this property label Biography information for Matt Hancock more like this
star this property tabling member
4605
unstar this property label Biography information for Bill Grant remove filter