ELISA reader - IVDR classification

#1
Hello everyone,

I am a Master student in Biomedical Engineering. By far I am working in start up company which manufactures ELISA reader (Class I IVD instrument- Self declaration).
Under the new Regulation (IVDR), our device will be classified according to Rule 5(b) as class A based on the intended purpose. The software drives or influences the device. The device is connected by a USB cable to the PC. The intended purpose for both the device and the software is the same. Means we consider both as a system (Software + IVD instrument, which is an ELISA reader).
My question is about the software now, is it a stand a lone software, is it embedded software or is it a software as Accessory for IVD? I am really confused now.
I will really appreciate you in advance!
 
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yodon

Staff member
Super Moderator
#2
Can the software be used on its own (without your IVD instrument)? Can your IVD instrument be used without the software?

Most likely, the software is just part of the system. If you look at the IVDR, you get a good idea of what's required. (IEC 62304 would be a good source also).
 

Rahim

Registered
#3
Can the software be used on its own (without your IVD instrument)? Can your IVD instrument be used without the software?

Most likely, the software is just part of the system. If you look at the IVDR, you get a good idea of what's required. (IEC 62304 would be a good source also).
First of all thank you so much for your information and secondly with regard to your questions, the software can not be used on its own. The IVD instrument can also not use without software. A firmware is embedded in the IVD instrument, it is connected through USB with the computer and the App should be installed on the PC. I agree with you the software is a part of the system. Can I use the term "software as accessory" for it ?

Kind regards,

Abdulrahim
 

yodon

Staff member
Super Moderator
#4
I don't think "accessory" is appropriate. 21CFR820.3 says (emphasis added):

(c) Component means any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device.

I believe your software (and firmware) are components.
 

twanmul

Involved In Discussions
#5
Agree with Yodon above and rule 1.4 of the IVDR corroborates this:

"Software, which drives a device or influences the use of a device, shall fall within the same class as the device."

An accessory would typically be classified in its own right. This is moot however as you're looking at a Class A device anyway...
 

Rahim

Registered
#6
Agree with Yodon above and rule 1.4 of the IVDR corroborates this:

"Software, which drives a device or influences the use of a device, shall fall within the same class as the device."

An accessory would typically be classified in its own right. This is moot however as you're looking at a Class A device anyway...
Many thanks for your information Twanmul.
So far our IVD instrument is classified as others IVD (Self-certification) according to Directive 98/79/EC. Now under IVDR we classify it under Rule 5(b) with implementing rule 1.4 as you mentioned. Our uncertainty is the following:
According to intended purpose our device is most likely reading any ELISA test. If a lab used our device for a reagent, for example, for HIV which will be high risk class and our IVD instrument is class A, however, we are not producing reagents.
What will be the consequences in this case ?
 

Rahim

Registered
#7
I don't think "accessory" is appropriate. 21CFR820.3 says (emphasis added):

(c) Component means any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device.

I believe your software (and firmware) are components.
Many thanks yodon!
 

twanmul

Involved In Discussions
#8
My understanding would be that their HIV kit would be Class D and your device would be used as a separate device (though used in combination) to read the test. It's difficult to say without knowing your devices intended purpose but it seems the Class A may be appropriate for you if it is a generic device.
 
#9
My understanding would be that their HIV kit would be Class D and your device would be used as a separate device (though used in combination) to read the test. It's difficult to say without knowing your devices intended purpose but it seems the Class A may be appropriate for you if it is a generic device.
Many thanks twanmul for your useful information!
 

yodon

Staff member
Super Moderator
#10
Can I use the term "software as accessory" for it ?
Can you? Sure! Should you? I wouldn't think so! :) Seriously, "accessory" has a specific definition (as well as "component"). If the software is part of the system then indicating it's an accessory would be inaccurate, I think. Now, will anybody care? That'll be up to a reviewer.
 
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