The United Kingdom has experienced several regulatory updates, as the Medicines and Healthcare products Regulatory Agency (MHRA) releases new documents and announces changes to standard practice designed to help combat spread of the COVID-19 pandemic.
Guidance establishes standards for emergency ventilators
The agency has published 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 employed here draw on the advice of anesthesia and intensive care medical professionals and medical device regulators. The ventilators covered here are designed to treat acute respiratory distress syndrome (ARDS) and are anticipated to be needed in large quantities as more people fall ill.
Form enables regulatory check for manufacturers of coronavirus test kits
A new form issued by the MHRA 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 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 coronavirus test kits approved for home use…