Due to the COVID-19 outbreak, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has been granting exceptions from certain regulation requirements on medical devices.
In June 2020, the MHRA published the first list of medical devices given exceptional use authorisation, with the aim of guaranteeing transparency through the supply of medical devices in the UK. Since then, it has been updated on a weekly basis, whenever there were new changes to be announced. The list was las updated on 21 June 2021 and the information published also includes expired and cancelled exemptions, which will remain listed for 2 months after expiry or cancellation date.
The process to obtain an exceptional use authorisation depends on the type of device. While ventilators, PPE, and COVID-10 testing kits have their own guidance and routes to be followed, for all other medical devices, manufacturers can apply directly to the MHRA. Furthermore, this exception can only be issued directly to the manufacturer of the medical device, while sales via distributors in not allowed.
Additionally, the MHRA only takes into consideration applications where a clinical need is evident and where CE marked devices or already derogated alternatives are not available.
Once a medical device has been granted an exceptional use authorisation, it can be sold to the National Health Service (NHS) to guarantee continuous medical devices’ supply.
Leyre Carrasco Alonso
Regulatory Affairs Department
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- The Medicines and Healthcare products Regulatory Agency. (2021a). Exemptions from Devices regulations during the coronavirus (COVID-19) outbreak. Retrieved on 12/07/2021 from https://www.gov.uk/guidance/exemptions-from-devices-regulations-during-the-coronavirus-covid-19-outbreak#approval-for-ventilators-ppe-and-covid-19-testing-kits
- The Medicines and Healthcare products Regulatory Agency. (2021b). Medical devices given exceptional use authorisations during the COVID-19 pandemic. Retrieved on 12/07/2021 from https://www.gov.uk/government/publications/medical-devices-given-exceptional-use-authorisations-during-the-covid-19-pandemic