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<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> |