Guidance

Specification for ventilators to be used in UK hospitals during the coronavirus (COVID-19) outbreak

This guidance sets out the clinical requirements based on the consensus of what is ‘minimally acceptable’ performance in the opinion of the anaesthesia and intensive care medicine professionals and medical device regulators.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 20 March 2020
• Last updated: 28 April 2020 — See all updates

Documents

Specification for Rapidly Manufactured Ventilator System (RMVS)

PDF, 503 KB, 25 pages

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Specification for Rapidly Manufactured Ventilator System (RMVS)

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Details

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.

The UK has fulfilled the clinical need for ventilators through a combination of existing certified ventilators on the market and existing applications to the Ventilator challenge. We aren’t currently able to proceed with any new applications.

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).

Published 20 March 2020
Last updated 28 April 2020 + show all updates

1. 28 April 2020

   Added information that we aren’t currently able to proceed with any new applications to provide ventilators that have not already started.

2. 20 April 2020

   Added a HTML version of the specification

3. 14 April 2020

   Published an updated version of the specification.

4. 26 March 2020

   Published an updated version of the specification document, and added links to other relevant guidance and standards.

5. 20 March 2020

   First published.