UK Announces COVID-19 Regulatory Measures on Medical Devices
March 27, 2020
The Medicines and Healthcare products Regulatory Agency (MHRA) has announced changes to standard practice designed to prevent spread of the COVID-19 pandemic.
New Guidance on Specification for Rapidly Manufactured Ventilator System (RMVS)
The regulatory agency has released a new guidance, Specification for Rapidly Manufactured Ventilator System (RMVS). This document specifies the minimum clinically acceptable performance requirements for ventilators during the COVID-19 pandemic. The standards draw on the advice of anesthesia and intensive care medical professionals and medical device regulators. The ventilators are designed to treat acute respiratory distress syndrome (ARDS) and are anticipated to be needed in large quantities as more people fall ill.
MHRA Form for COVID-19 Test Kits
MHRA has issued a new form which allows manufacturers of professional-use test kits to confirm that their products are legal to put on the UK market. The form must be completed and submitted to the email address given in the announcement, and device performance data must also be supplied. Further specifications for COVID-19 test kits are being developed and will be published as soon as they are available. The accompanying notice also reiterates that there are no CE marked COVID-19 test kits approved for home use.