'Active' device? Software/laptop with attached camera 'looking' at passive metal probe

M

matthuck

Registered
#1
#1
Hi all,

I have a potential device - software/laptop with attached camera 'looking' at passive metal probe used to determine locations in space of various bones (surgically).

In terms of an active device definition - I am struggling with the definition of administer or exchange of energy:

The laptop converts electricity in order to power the software.
The camera converts visual images in to electronic signals
The probe converts mechanical resistance of motion (ie the user pushing it against bones) in to a visual position (visual images)

However, none of these really appear to be administer or exchange of energy and certainly no contact with patient.

Anyone have any opinions (asking the internet for an opinion haha)?

Examples of something similar might be (wikipedia.org/wiki/Stereotactic_surgery)
 
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T

twanmul

Involved In Discussions
#2
#2
It doesn't need an opinion, it's quite clear from the MDR definition:

"‘active device’ means any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy. Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be deemed to be active devices.

Software shall also be deemed to be an active device;"

Hope that helps.
 
M

matthuck

Registered
#3
#3
Thanks for the reply - I actually had the opportunity to submit under MDD (maybe include under an existing Certificate scope) which I missed in my original post.

MDD didn't as clearly call out software and it was this that I struggled with. You are right - the MDR is a lot clearer!

In my original post, would you say that powering the software in the laptop is acting to change the density or converting the energy?

I am happy that my device is classified, and have no major challenge whether it is or isn't an active device, just trying to determine a good 'why'?
 
T

twanmul

Involved In Discussions
#4
#4
Within the definitions of the Classification Annex IX of directive 93/42/EEC it says:

"1.4. Active medical device
Any medical device operation of which depends on a source of electrical energy or any source of power other than that directly generated by the human body or gravity and which acts by converting this energy. Medical devices intended to transmit energy, substances or other elements between an active medical device and the patient, without any significant change, are not considered to be active medical devices.

Stand alone software is considered to be an active medical device."

There are only slight differences between this and what is in the MDR. Active Devices aren't listed in the main definitions section (article 1) but are within the classifications section. Even the AIMDD (90/385/EEC) has a very similar definition for active device and talks about software within the definition. As such, I don't see any room for interpretation here.

It sounds like everything you have here is a device, with the probe potentially (though this isn't my area of expertise and I'm happy to be corrected by others) being a device accessory.
 
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