Can a power Supply be an accessory to a medical device, if it is an 'off-the-shelf' product.

#1
Hi All, I have an off the shelf AC/DC adapter to power an induction loop charger for a wearable medical device. the Micro USB plugs into the charging unit with an internal Battery. The AC/DC adapter plugs received the USB connection to the Changing unit plugs into the wall. the charger unit is not used when the device is used for it's intended purpose and purely serves as a means to charge the device at the end of each day. Can this be classified as an acessory, or other means to abdicate the AC/DC adapter as part of the medical device system? The device comes under the home healthcare category
 
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Peter Selvey

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#2
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.
 

yodon

Staff member
Super Moderator
#3
...purely serves as a means to charge the device at the end of each day
When I read that, I take it that it's necessary to have the charger as part of the "system." The "system" cannot function if the charger is not provided. So to me, this makes it a component in the system and, as @Peter Selvey points out it has to meet the requirements for the countries in which you distribute.
 

Peter Selvey

Staff member
Super Moderator
#4
Just to clarify, for the parts in the system, the responsibility for regulatory compliance remains with the labelling manufacturer (with some back up responsibility on the importer, if applicable).

So if "X" puts together a system using items that are already legally sold in a particular country there is no direct or formal obligation to verify compliance. There is just general negligence/liability. For example if you used a CE marked power supply from no-name brand from a region in the world that is known for fake stuff, it's really cheap and purchased it all on Amazon, and that power supply turns out to burn down someone's house, then negligence is in play.

But if the power supply is a well known brand, has certification marks (TUV, UL etc.), bought direct via a reputable distributor and at a reasonable price, I wouldn't dig into it. Actually, it's not really practical to take responsibility for compliance without signed contracts and agreed information exchange, which would not make sense for every item in a system or set. So it's really just a background check to make sure it's not something dodgy you are including in the system.
 
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