Classification of Active non-implantable diagnostic device

pseudoazurin

Involved In Discussions
Hi All,

Want to check whether people have classification with this. Got a electrophysiology (EP) product which use catheter electrodes to the heart. So by Rule 6, it should be Class III, but since the product is just the signal recorder box, and the catheter electrodes are not included and used those already in the market, so if just EP box, but Rule 10, it would be Class IIb. In a way, the invasiveness make it III, but that is the already marketed invasive electrode, but our product.

Any suggestion/comment?
 

EmiliaBedelia

Quite Involved in Discussions
The classification rules should be applied specifically to the component you are classifying. If there are multiple devices that work together, you would classify them all separately. So, if you have the cathodes and the box (each provided separately), you would classify them individually. If the box is not surgically invasive, you would not use Rule 6.

This might be different if you are defining the set as a "system" or "procedure pack", but it sounds like you have 2 separate devices and are not treating them as 1 device, collectively.
 

pseudoazurin

Involved In Discussions
Thanks for the clarification. My concern was that the box itself, alone, is not really "functional" to achieve the intended purpose.

On a separate but probably related situation, would there be cases that people would "benefit" from such grouping, i.e. say a Class III product, but my splitting it into say two+ components, they become IIb products, thereby skipping some of the hassles.
 

EmiliaBedelia

Quite Involved in Discussions
Annex VIII 3.2 specifically states that the classification rules apply to each device individually. Remember that you have to describe the intended purpose and demonstrate compatibility of the devices anyway as part of the GSPR/technical documentation, so you are already responsible to show that they achieve the intended purpose when used together. It might feel like "cheating" to separate them out and arrive at a lower risk class, but remember that the classification rules are not just about the risk level, they also encompass the "means of action" and key device characteristics. It is actually not ideal to classify a non-invasive, active device as Class III per Rule 6, because that rule does not actually describe the device.

On a separate but probably related situation, would there be cases that people would "benefit" from such grouping, i.e. say a Class III product, but my splitting it into say two+ components, they become IIb products
I don't think so....but it's definitely possible that there's an edge case where this is true :)
The classification rules are intended to be applied based on the intended purpose (Annex VIII, 3.1), which should be the same even if you consider the devices separately. I would think even if one device takes on a lower classification, at least 1 device will retain the higher risk class because that device is probably primarily responsible for achieving the intended purpose.

However, I think this is kind of a moot point, because the regulation itself states that the classification rules shall be applied to each device individually. So there should not really be a question of whether it is more advantageous to do it one way or another, because that is the right way to assess classification based on Annex VIII. There may be some advantages to defining your device as a system (as opposed to multiple individual devices, for example) but that is not the same thing as determining classification and there are more factors to consider if you are thinking about system vs. multiple devices.
 

Ronen E

Problem Solver
Moderator
There may be some advantages to defining your device as a system (as opposed to multiple individual devices, for example) but that is not the same thing as determining classification and there are more factors to consider if you are thinking about system vs. multiple devices.
I'd like to highlight that there really isn't a choice if the product qualifies as a Medical Device according to the MDR definition - in that case it must be treated as a Medical Device and CE marked in its own right, regardless of whether or not it's supplied as a part of a System or Procedure Pack.

When a bunch of items are sold/supplied together there is sometimes a choice whether to manage this as a group of items that are sold/supplied together or as a System or Procedure Pack under the MDR. But that's a separate issue.
 

Ronen E

Problem Solver
Moderator
My concern was that the box itself, alone, is not really "functional" to achieve the intended purpose.
This implies that the electrodes might be Accessories in the MDR sense (enablers). It doesn't necessarily mean that the box is not a Medical Device when placed on the market. I don't know this application field and it's technical nuances, so I have to stay a little indeterminate about it.
 

pseudoazurin

Involved In Discussions
This implies that the electrodes might be Accessories in the MDR sense (enablers). It doesn't necessarily mean that the box is not a Medical Device when placed on the market. I don't know this application field and it's technical nuances, so I have to stay a little indeterminate about it.

It is a MD as said above, whether our box is a IIB or III would make a difference, especially if we are not going to sell the catheter electrode. (compatibility is a separate issue)
 

pseudoazurin

Involved In Discussions
Sorry, I presume it is clear that the catheter electrode is directly onto the heart (i.e. internal), but they are already on the market, but the box is with new function, but external. I thought that Rule 6 would apply, but now it seems Rule 10 is the one.
 
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