Europe – European Commission publishes survey results on Notified Body COVID-19 capacity

The European Commission made available a number of new resources for use during the pandemic, including a detailed report listing average Notified Body processing times for devices relating to COVID-19.

Survey of Notified Bodies reveals conformity assessment capacity

In the “Joint European Roadmap towards lifting COVID-19 containment measures” that was adopted on April 15, the European Commission made a commitment to gather and publish information on the availability and capacity of Notified Bodies to perform conformity assessments for medical devices and IVDs related to the diagnosis and treatment of COVID-19. In pursuit of this goal, the EC conducted a survey from May 7-13, sending questions to Notified Bodies about their processing times for different procedures and device classes. The results have now been released as a guide for device manufacturers and other economic operators…