The agency noted in new guidance that COVID-19 and other factors are creating obstacles for labelers in meeting the UDI direct mark requirements for certain finished devices already manufactured, labeled and in inventory. Read More

“The medical technology industry would strongly encourage allowing ‘virtual audits’ when necessary and consider them as a tool to overcome challenges linked to the CE marking procedure when on-site audits cannot be performed,” MedTech Europe said. Read More

The EMA commissioned the ACCESS project with Utrecht University in May to study data sources and methods that can be used for the postmarketing evaluation of COVID-19 vaccines. Read More

The kit “has the ability to isolate and concentrate target molecules, making them easier to detect,” Phase said. Read More

The test simultaneously detects antibodies against three antigens and can handle up to 96 patient samples in under three hours. Read More

The vaccine also generated a strong T-cell response, which helps immune response. Read More

The UK also secured COVID-19 neutralizing antibodies from AstraZeneca for people who cannot tolerate vaccines. Read More