Starting point is the labelling. If the labelling manufacturer placed the device on the market as a general device, then it's not a medical device, even if it ends up being used for a medical purpose. For example if a ruler was used to make a measurement on a diagnostic chart, it is being used for a medical purpose. But if the ruler came from the local office supplies store, it's not a medical device, as the manufacturer of the ruler never stated that as an intended purpose.
If an entity places a group of devices or items on the market as a "set", that principle still applies. Lets say the entity is company "X".
If there are items in the set that are not labelled by X, then X should make sure that for each item:
- the original labelling, IFU and possibly packaging (if needed for compliance) are preserved
- some effort to check approvals etc are all in order for the country of sale (e.g. normal safety/EMC for an ac/dc adaptor)
{this is to avoid that X knowingly imports and distributes an item not meeting local regulations, general responsibility}
For medical regulations X should consider compatibility issues and risks arising from the set, which should be documented in the risk management file. Since this is wireless charging only, there's not much to consider. An example of a criteria may come out of a risk analysis is that the power supply should have no more than 15W output (5V/3A), in order to avoid flammability requirements in the charging unit. Another example to consider might be if the user connects to another USB supply (might be no significant risk). And so on.
In the EU, it's required to draw up a declaration to the above.
Not sure if I made it too confusing? But anyway it all makes sense if you think about it.
