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Question about qualification as a medical device or accessory in Europe

#1
Dear all,

I hope this message finds you well.

I have a question regarding the qualification as a medical device or an accessory in Europe for the following products:

1) Emergency cart. It supports a defibrillator, IV bags, CPR, sharps container, and an oxygen tank.
2) Mobile workstation, Powered. It can support a computer which can use medical software.
3) Overbed table to use with beds and chairs. It is intended to use in a hospital setting.

I thought that products 1 and 2 are accessories since they enable a medical device (for instance, the IV hook and a powered mobile workstation for a computer with a medical software). About product number 3, I am in doubt if it is a medical device.

What do you think?

Thank you very much in advance!
 

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dgrainger

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#2
It needs to be an accessory to a specific device (or group of devices) - The device will mention the accessory in its IFU and Technical file.
None of your examples will necessarily qualify as an accessory.
For example the defibrillator, IV bags, CPR, sharps container, and an oxygen tank can operate as intended without a cart.
The software can operate without a mobile workstation.
The overbed table needs a device to be an accessory to it.
 

Ronen E

Problem Solver
Staff member
Moderator
#3
The device will mention the accessory in its IFU and Technical file.
I think this might be a bit too cut and dry. Some devices will definitely need an accessory to achieve their intended use but will not call out a specific brand or model (only provide minimum specifications).
The accessory's IFU should mention the device it is intended to enable, but again this can be a group of devices or brands.
The official definition is quite broad and the MDR might have made it slightly more elusive than before (MDD).

@dinaroxentool A general purpose computer is not a medical device even if it can run a medical SW. However if a workstation is sold complete with the computer and SW installed the entire setup would qualify as a medical device. IMO the emergency cart might be a borderline case and qualify as a medical devices in its own right - depends on what exactly it contains and how it is instructed to be used (need to review the labeling).
 
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