MDR's must be filed for adverse events overseas!

The FDA called a device "misbranded" in a warning letter to an Italian company because the company failed to file MDR's for adverse events that occurred in Europe. The device is also marketed in the US. The company took the position that non-US adverse events would be exempt from MDR reporting, and the FDA took exception to that, saying "The MDR regulation applies to foreign manufacturers whose devices are in commercial distribution in the US. An adverse event that occurs overseas is reportable under the MDR regulation if the device is one that has been cleared for marketing in the US".
Just so you know!