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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.
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.