The European Commission released a factsheet on how the EU’s new regulations for medical devices and diagnostics and said they may cause temporary shortages.
The commission warned devicemakers that under the new regulations, approximately 85 percent of all IVDs will require notified body oversight, compared to 20 percent under the old regs Additionally, devices and services sold over the Internet are now “explicitly covered” by the new regulations, the commission said.
“These changes could have consequences for the availability of medical devices for health institutions. For instance, manufacturers may choose to stop the production of certain medical devices,” the commission said. “Furthermore, if certain medical devices do not get their certificates on time these products may become temporarily unavailable.”