MHRA updates specification for ventilators to be used in UK hospitals during COVID-19 emergency
MHRA updated the guidance on the clinical requirements to consider for ventilators during COVID-19 emergency.
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.
The guidance is for devices which are most likely to confer therapeutic benefit on a patientsuffering 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 CEmarked ventilators and existing applications to the Ventilator challenge.
For more details, please see the orginal communication from MHRA
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.
20 April 2020 – Added a HTML version of the specification
14 April 2020 – Published an updated version of the specification.
26 March 2020 – Published an updated version of the specification document, and added links to other relevant guidance and standards.
20 March 2020 – First published.
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This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
