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938808
unstar this property registered interest false more like this
star this property date less than 2018-07-11more like thismore than 2018-07-11
star this property answering body
Department of Health and Social Care more like this
star this property answering dept id 17 more like this
unstar this property answering dept short name Health and Social Care more like this
star this property answering dept sort name Health and Social Care more like this
star this property hansard heading Podiatry remove filter
star this property house id 2 more like this
star this property legislature
25277
star this property pref label House of Lords more like this
star this property question text To ask Her Majesty's Government whether they will fund an independent evaluation of the efficacy of laser equipment in the treatment of fungal infections by the podiatry profession, in order to assess the claims of some equipment manufacturers. more like this
star this property tabling member printed
Lord Campbell-Savours more like this
star this property uin HL9424 more like this
star this property answer
answer
star this property is ministerial correction false more like this
star this property date of answer less than 2018-07-23more like thismore than 2018-07-23
star this property answer text <p>Laser equipment, if presented by a manufacturer for the treatment of nail fungal infections, is a Class IIa medical device. As such, the manufacturer of the laser equipment is required to meet the requirements of the Medical Devices Regulations 2002. For a Class IIa device the manufacturer must have a quality management system in place and they must obtain the services of a Notified Body, who will assess the safety and performance of the device before issuing a CE certificate to the manufacturer for the products. The Notified Body assessment will include all aspects of the device, including verification of the manufacturer’s testing for the performance and safety of the device, the manufacturing processes and components of the device and review these in the light of the claims made by the manufacturer for the device concerned. As such, there are no plans to fund an independent evaluation, however concerns about the safety or performance of a medical device should be reported to the Medicines and Healthcare products Regulatory Agency who will investigate accordingly.</p>
star this property answering member printed Lord O'Shaughnessy more like this
star this property question first answered
less than 2018-07-23T14:05:44.627Zmore like thismore than 2018-07-23T14:05:44.627Z
star this property answering member
4545
star this property label Biography information for Lord O'Shaughnessy more like this
star this property tabling member
499
star this property label Biography information for Lord Campbell-Savours remove filter