Exceptional use authorisations for medical devices during COVID-19

The Medicine and Healthcare Products Regulatory Agency (MHRA) have released a list of medical devices granted exceptional use applications during the pandemic.

Medical devices granted an exceptional use authorisation can be sold to the NHS and within the social care setting to ensure a continued supply of medical devices. The MHRA will only consider applications for exemptions where there is a clear clinical need and no available supply of CE marked alternatives. They have released specific guidance for approval of certain devices such as ventilators, personal protective equipment, and COVID-19 testing kits.

For any other type of medical device, applications should be made directly to the MHRA via devices.exceptionaluse@mhra.gov.uk. A full list of inclusion criteria for the application can be found here, along with more information on derogation of medical devices during COVID-19. It is expected that the applicant will provide evidence that the device performs as intended, in the form of performance data and any other study data.

To view the list of devices granted exceptional use authorisations, click here.

In the US, the Food and Drug Administration (FDA) are issuing emergency use authorisations (EUA) for diagnostic and therapeutic medical devices related to COVID-19. Click here for more information.

It may also be useful to take a look at the European Commission guidance on medical devices in the COVID-19 context. When it comes to derogation or exemption, each national competent authority is responsible for the assessment.