European Commission Appoints 12th MDR Notified Body
Despite industry’s urgent need to have their products assessed by notified bodies under the MDR, appointments are coming through slowly.
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While the UK is moving forward quickly to provide COVID-19 antibody self-testing, the Belgian government considers the tests not sufficiently accurate to be used in the pandemic.
Following hot on the heels of its Rapidly Manufactured Ventilator Specification document, the UK’s regulator has issued another speedy regulatory permit for fast production of respiratory assist devices.
The UK is taking measures to increase its ventilator stock from 8,000 to some 30,000, but it will take time to make them available. Many are asking whether the government really rejected EU help, which could have brought relief sooner, because of Brexit.