Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what the process is for evaluating new medical devices for the treatment of chronic neuropathic pain conditions for use in the NHS.

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for ensuring that medicines, medical devices, and blood components for transfusions on the market in the United Kingdom are safe, effective, and manufactured to the highest standards of quality. The Medical Devices Regulations 2002 (MDR 2002) established the statutory framework that medical devices must meet in order to comply with these standards.

All medical devices, including those used for treatment of chronic neuropathic pain conditions, must comply with the MDR 2002, which include bearing the UKCA or CE marking on the packaging or labelling of the device. Manufacturers or their United Kingdom based representatives must monitor use of these devices when used in the UK. The MHRA does not grant clearance or approval for medical devices, outside of exceptional circumstances. The manufacturer holds the legal responsibility for obtaining the necessary certification and registering their medical devices with MHRA, the UK competent authority. Higher risk medical devices are assessed and approved by Approved Bodies in the UK or Notified Bodies in the European Union.

The MHRA is not responsible for the procurement aspects of the NHS organisations, as that is outside the MHRA’s remit.