Question to the Department of Health and Social Care:

To ask His Majesty's Government what monitoring or enforcement action the Medicines and Healthcare products Regulatory Agency has taken in relation to NHS Trusts using unlicensed products outside their intended purpose in surgical settings.

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for enforcing the medical device regulations applicable in the United Kingdom. These regulations are predominantly product safety regulations. The MHRA’s regulatory remit centres on whether the device has been manufactured and placed on the market or put into service in compliance with the UK Medical Devices Regulations 2002 (as amended). The MHRA’s regulatory remit does not extend to scenarios where healthcare professionals decide to use a compliant medical device outside of its intended purpose. This activity would likely be regulated by the Care Quality Commission or the General Medical Council, for example.

Medical devices are not licensed by the MHRA. For the lowest risk devices, Class I devices, manufacturers can self-declare that their device conforms with the applicable medical device regulations prior to placing their device on the market. For Class IIa, IIb, and III devices, manufacturers will have to engage the services of a conformity assessment body. Either a UK Approved Body in order to affix a UKCA conformity mark or a European Union Notified Body in order to affix a CE conformity mark. The conformity assessment body issues a certificate before the manufacturer can place their device on the market.

The activity of using a medical device outside of its intended purpose is generally referred to as ‘off-label’ use. The MHRA has produced guidance concerning off-label use of a medical device, Off-label use of a medical device, which is available on the GOV.UK website. Medical devices should be used as described by the manufacturer in the instructions for use. If a device is used in any other way, it’s considered off-label use. Without the manufacturer’s approval this will be at the user’s risk, and they or their employer could become liable for civil claims for damages.

Where the MHRA receives information suggesting a National Health Service trust was in possession and using non-compliant medical devices, we would make enquiries to ascertain how the NHS trust came into possession of the non-compliant device and would also take mitigating steps to remove it, ensuing patient safety risk. The guidance Regulating medical devices in the UK provides a more detailed explanation on how medical devices are placed on the market and is available on the GOV.UK website.