Dialysis Machine is CE Marked as a Medical Device - Accessory or not?

R

Rob Udo

#1
Situation:

Dialysis machine is CE marked as a medical device
Reverse Osmosis machine is CE marked as a medical device

The user of the devices, a dialysis centre, installs the dialysis machine and RO machine at the patients home. The RO machine must operate in order to allow the dialysis machine to work. The RO machine has a manual on/off button and is often installed at a less accessible place due to the noise of the RO machine. In order to support the patient, the dialysis centre has made a small Printed Circuit Board which provides a signal form the dialysis machine (when it is turned on) to the RO machine to start (wake up from standby mode).

The supplier of the dialysis machine (who is not the manufacturer) has made an objection to the dialysis centre that they may not modify a CE marked product. That is correct in my opinion.
The supplier is not the manufacturer of the dialysis and Reverse Osmosis (RO) machine. The manufacturer does not intent to cooperate in any submission for a revised device.

The dialysis centre is looking for an alternative solution to help the home-users. Now they intent to make an external box to wake up the RO machine. In order to achieve this they:

- Use an unused 24V power output from the inside of the dialysis machine. They have to plug in a connector in the 24V connector inside the machine. Is this a modification of the machine? I guess yes…
- The external box wakes up the RO machine based on the 24V power supplied by the dialysis machine.

Is this external box an accessory?
Is this ‘putting on the market’? It is not a device in itself, and it is not separately sold.

I would like to get your advice on how to handle this in regard to the MDD. Any thoughts are highly appreciated.
 
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pkost

Trusted Information Resource
#2
Where does it say that someone is not permitted to modify a CE marked device?!?! It may be difficult to be regulatory compliant but it is not prohibited or even impossible.

firstly the easy question: The box that you propose is certainly an accessory, whether it has to be CE marked and comply with the directive is dependent on whether it is considered to be placed on the market


If this modification, or extra device was in a hospital setting on a hospital site then the hospital could make the change or make their own device and not have to worry about CE marking as they are not placing on the market. The scenario you give however is in a home setting.

I suspect that if the devices were being provided as part of a service that were used and maintained by a medical professional in the treatment of the patient, then the service who provided the professional and equipment could say that they weren't placing the product on the market and therefore didn't require a CE mark.

However, consdiering the type of device, length of use, patient use (as opposed to professional use), I suspect that the case here is that it is not really a service in that sense; in which case CE marked products would be required

For a definitive view you may want to speak to a legal expert. Alternatively if your competent authority is helpful, give them a call and the scenario and ask them the box would be considered to be placed on the market....Their written response should be sufficient as they are the ones that will enforce the regulations.
 

Ronen E

Problem Solver
Staff member
Moderator
#3
Hi,

Please note that the MDD has "putting into service" on top of "placing on the market".

This aside, I think that if they open the dialysis machine and hook up to a 24V output (either already in use or not), which the manufacturer didn't intend as a signal output for users, this is a device modification. The usual set of safety requirements applies, for starters.

If not a device modification, this control box would definitely be an accessory to the dialysis machine, since it'd be intended to allow the dialysis machine (=the device) to achieve its own intended purpose (by availing the purified water). Without the box the RO machine will stay idle and the dialysis machine could not operate properly.

Cheers,
Ronen.
 

pkost

Trusted Information Resource
#4
Is there any guidance on what "putting into service" encompasses? I've not come across it before (because I've always placed on the market)

I was under the impression that an entity could modify/create a device for their own use and not have to comply with the MDD
 
#5
Is there any guidance on what "putting into service" encompasses?
This was something new for me as well. Both "placing on the market" and "putting into service" are definitions in the directive (paragraph 2 (h) and (i)). But looking through the directive I cannot see where they are treated differently.

But you may notice that the definition for "putting into service" was included as part of the modification 'M1'. On the front page M1 is shown to be Directive 98/79/EC, which is the IVD directive. So, I suspect, that the extra definition has been included so as to align with the IVDD. As for what the difference is - I am not familiar with that directive but there is facility in there for making IVDs available for performance evaluation which may have something to do with it.

With regards the original questions:
I would tend to agree with the pkost - it is an accessory and, if the dialysis equipment was modified by the institution who then provide it as part of a complete service (clinical care, equipment management / maintenance, training etc) then it may be seen as not being placed upon the market.
 
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