If a device maintains a certain status in another country or countries, that status does not by default extend to the US. Thus, if a device is considered Class I in Europe, that does not necessarily mean it would be considered Class I in the US (although it is possible it could ultimately be classified in Europe and the US as Class I). If used in a clinical investigation in the US, the device would still have to meet all the standard FDA requirements for clinical investigations of devices regardless if used within or outside its European labeling.
