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Software as an accessory to a Class I medical device

#1
I have a HW medical device that is classified as class I device according to MDD. The device is used for documenting pictures used by a doctor to diagnose disease. A new software feature will be added that will be able to provide diagnosis instead of the doctor.
1. The new feature is not an integral part of the device you would buy, the user will be able to purchase it separately
2. It only works with my HW device, so it is not a stand alone software device
3. The intended use of the feature is different from the intended use of the device

Can I treat this software feature as an accessory to a medical device? I am looking through regulation and it is very unclear when it comes to software.
If it is indeed an accessory, do I need to prepare a separate technical file for the software? or will it be part of my HW device TF?
 

yodon

Staff member
Super Moderator
#2
Does your existing hardware work without the software? Presuming so, will you sell a version without the diagnostic software and a version with the diagnostic software?

By incorporating diagnostic capability I would expect you've bumped the device out of the Class I category.
 
#3
No, it can't be an accessory as it has a medical purpose - diagnosis! It is a device in its own right.
I would consider that it is intended to "allow direct diagnosis" and will be class IIa under MDD.
Under MDR, it will be at least class IIa - depends on what it is diagnosing and situation it is used.
 
#4
Does your existing hardware work without the software? Presuming so, will you sell a version without the diagnostic software and a version with the diagnostic software?

By incorporating diagnostic capability I would expect you've bumped the device out of the Class I category.
The Diagnostic software is an add-on to the existing device and software. User will be able to purchase it separately, once he has a device.
How do I keep the device and the diagnostics software separate in my documentation? The device without the software is class I but once the software is purchased it's, as you say, bumped into class IIa.
Can I call it a standalone software? even though it will only work with my device?
 
#5
No, it can't be an accessory as it has a medical purpose - diagnosis! It is a device in its own right.
I would consider that it is intended to "allow direct diagnosis" and will be class IIa under MDD.
Under MDR, it will be at least class IIa - depends on what it is diagnosing and situation it is used.
Thanks, of course you are right about the classification.
I am confused on how to treat this software. If it is not an accessory is it a standalone software? it will only work on my HW device.
I don't want to change the classification of the device as is (class I) since it will not have the diagnostics function when purchased and may be used without it.
 
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