I would add on to the list of various devices being classification differently between the US and EU with needle destruction devices. These are not considered medical devices in Europe but they are class III in the United States. In Europe, these devices go through electrical safety and electromagnetic compatibility and compliance to the European low voltage and other electromagnetic compatibility directives. However, in the US, these devices need PMA, clinical trials etc before entering the market.

Another example is dental splints (preventing teeth grinding). As is, these devices are class I in both the US and EU. But if the manufacturer claim that the devices also prevents migranes, they would be considered as class III devices in the US and class I in Europe.

Reference: “Is my product a medical device?” (Emergogroup)