IVDR Notified Body Pulls Applications As The EU System Struggles To Cope
European Commission figures have already suggested IVD testing capacity could be woefully short of demand. Now one notified body applicant is dropping out. What are the implications?
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NSF Ireland recently withdrew its application for notified body status under the IVDR and MDR. Its reason? Demand among manufacturers for consultancy outweighs the need for another notified body. But aren't more notified body resources needed too?
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.