The guidance is for devices which are most likely to confer therapeutic benefit on a patient suffering with ARDS caused by SARS-CoV-2, used in the initial care of patients requiring urgent ventilation.

We aren’t currently able to proceed with any new applications to provide ventilators that have not already started. The UK has fulfilled the clinical need for ventilators through a combination of existing CE marked ventilators and existing applications to the Ventilator challenge.

Further information from the Cabinet Office who are running the Ventilator challenge.

We are aware that there are several international groups, including the World Health Organisation (WHO), are referring to it for their own emergency ventilators.

We will continue to make our latest specification available.

Further information

There is guidance on the specification for Rapidly Manufactured CPAP System.

We have also published guidance on Exemptions from Devices regulations during the coronavirus (COVID-19) outbreak.

The British Standards Institution have made their standards on ventilators accessible free of charge.

MHRA guidance on coronavirus (COVID-19).