§ Bob SpinkTo ask the Secretary of State for Health (1) if he will relax the three year rule for issue of a CE mark for prosthesis so as to enable amputees to test new products while remaining supported by the NHS; [118455]
(2) if he will make it his policy to allow an NHS provided and supported socket to be fitted to a J-leg prosthesis that is privately made and not CE marked to allow it to be tested in use by above knee amputees. [118456]
838W
§ Ms Rosie WintertonMedical devices placed onto the United Kingdom market must comply with the provisions of the Medical Devices Regulations 2002 and be CE marked by their manufacturers to demonstrate this compliance. The Regulations impose various obligations upon manufacturers designed to protect patients and users by ensuring that devices are safe and fit for their intended purpose. There is no time limit imposed by the Regulations on when devices can be CE-marked.
The Regulations allow non-CE-marked devices to be placed on the market in three specific circumstances. These are: where the device is custom-made for an individual patient on the basis of a prescription from a duly qualified medical practitioner; where the device is made available as part of a controlled clinical trial run by the manufacturer to gain evidence to support its eventual CE-marking; and for use for an individual patient where no suitable CE-marked device is available. In these latter two situations, the agreement of the Medicines and Healthcare products Regulatory Agency, which is responsible for enforcing the Regulations, must be obtained in advance.