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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>
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