REF and CE mark symbols on multi-component device

StephanieE

Registered
We have large device made of several component each shipped separately and then connected up / assembled into the Medical Device.
In this case I have considered the components to be Spare Parts of the overall Medical Device.

I am now wondering what the "REF" corresponds to in this scenario.

Does each of component have the REF symbol with the finished Medical Device reference number next to it
or
Does each component have the REF symbol with its own spare part reference number next to it?

Do I place the CE mark on one of the component or repeat it on all of them?

Thank you for your advice!
 

yodon

Leader
Super Moderator
How can they be considered "spare parts" if they're assembled into the final device? Are they required? If not, they may be accessories.

REF is the part number - what the customer would cite if ordering. If I understand correctly, each component would have a unique REF.

Not sure about the CE mark since unclear what these things are. Can you provide more details?
 

StephanieE

Registered
Thanks Yodon, I will try to clarify.

Each part of the system is shipped separately and assembled at the hospital to have a fully functioning system.

So for example we would ship a camera, a cart, a CPU, a robot, and a remote separately (each component does not have a clinical purpose on its own), we would then assemble at the hospital them to make the device (which has a clinical purpose), and if any of the components we shipped was to malfunction we would send a replacement part.
All components are essential to the function of the device, which is why I would not consider them accessories.

Does this make more sense?
 

Ronen E

Problem Solver
Moderator
You should look at the shipping as an internal step in your manufacturing process. The device is finished only once it's fully assembled at the hospital. This may have broad consequences on what you need to do, and how, for regulatory compliance. Once the device is assembled and finished you should apply a CE mark to the finished device / the system in a way that reasonably clarifies that it relates to the whole device / system.

The individual elements should not be CE marked as medical devices. If any other EU Directives or Regulations that include CE marking provisions (e.g. RoHS) are applicable, the relevant elements must comply and be CE marked accordingly. If none apply to an element, that element shouldn't be CE marked at all. To avoid trouble at border control etc., you may add clarifying statements on the labelling and accompanying administrative paperwork.

I agree with yodon that each element should bear its own part ID. Whether or not to use the REF symbol depends on the applicable Directives / Regulations.
 
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