Requirements for distribution of Class I and Class IIa CE Marked Medical Devices

E

Embryo

#1
Hi,

The elsmar Cove forums are a great source of information, but I have not found the answer to this question (yet) so here goes...

I am working at a company that produces class I and class IIa medical devices (CE-marked, 510(k) cleared etc.). Currently we sell only our "own" products, we are not a distributor or contract manucaturer.

The users of the class IIa devices are (according to the User Manual)required to regularly validate the performance of the device before using it. We regularly service the devices (at the location where they were installed), using (calibrated) equipment that we have found adequate for the task. However, our customers are not so proficient in using the said equipment required for validating the performance of the device and would like another method for validating the performance.

We have now found a possible solution to the above issue. However, this suggestion involves using a (single use) medical device (not manufatured by us, we have no relation whatsoever with the manufacturer). Now here comes the question...

What are the concequences for and requirements on us, if we were to (re)sell a medical device, manufactured by another company? Please note that we, not in any way intend to modify the medical device and/or repackage or relabel it (we buy a box from the manufacturer and send it to our customers, as "simple" as that). Our intention is to make it more convenient for our customers, enabling them to buy our medical device from us and in addition, at the same time, another medical device (not manufactured by us) that they may use to validate the performance of our device, releaving them of the extra effort connected with buying the other medical device from another company.

Are there any requirements at all (if we sell medical devices manufactured by other companies) on us, if we no dot alter it and only sell it on markets where it is already available?

The idea is that we purchase a number of (single use) medical devices from a lot, test this lot together with our medical device, and if we are satisfied with the result, make the remaining medical devices that we purchased, of this lot, available to our customers for purchase.

Any thoughts on the above is much appreciated!

Best Regards
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Hi,

The elsmar Cove forums are a great source of information, but I have not found the answer to this question (yet) so here goes...

I am working at a company that produces class I and class IIa medical devices (CE-marked, 510(k) cleared etc.). Currently we sell only our "own" products, we are not a distributor or contract manucaturer.

The users of the class IIa devices are (according to the User Manual)required to regularly validate the performance of the device before using it. We regularly service the devices (at the location where they were installed), using (calibrated) equipment that we have found adequate for the task. However, our customers are not so proficient in using the said equipment required for validating the performance of the device and would like another method for validating the performance.

We have now found a possible solution to the above issue. However, this suggestion involves using a (single use) medical device (not manufatured by us, we have no relation whatsoever with the manufacturer). Now here comes the question...

What are the concequences for and requirements on us, if we were to (re)sell a medical device, manufactured by another company? Please note that we, not in any way intend to modify the medical device and/or repackage or relabel it (we buy a box from the manufacturer and send it to our customers, as "simple" as that). Our intention is to make it more convenient for our customers, enabling them to buy our medical device from us and in addition, at the same time, another medical device (not manufactured by us) that they may use to validate the performance of our device, releaving them of the extra effort connected with buying the other medical device from another company.

Are there any requirements at all (if we sell medical devices manufactured by other companies) on us, if we no dot alter it and only sell it on markets where it is already available?

The idea is that we purchase a number of (single use) medical devices from a lot, test this lot together with our medical device, and if we are satisfied with the result, make the remaining medical devices that we purchased, of this lot, available to our customers for purchase.

Any thoughts on the above is much appreciated!

Best Regards
Hi,

Regarding on-sale of non-modified medical devices manufactured by others (and only this aspect) - the requirements that apply to you are those applicable to medical devices distributors, full stop. Since you didn't specify the target market it's a bit difficult to be more specific.

Regarding the use of these devices for validating your own devices' performance, and the entire set-up you described - it's a new method, and as such it should be validated in itself, i.e. it must be well-substantiated that this method will consistently produce acceptable end-results, that is - your customers will always (including worst-case scenarios) get reliable results when they validate your device's performance through this method. This method validation should (among other factors) address the initial lot qualification you conduct, as well as account for the purchased validating device's inherent variability under worst-case circumstances, and - unless you have a written agreement with the manufacturer to address that - the possibility of un-notified associated change implemented by the manufacturer.

Cheers,
Ronen.
 
E

Embryo

#3
Hi again,

Many thanks for the valuable feedback.

The issue has taken a new twist…:

What about changing the intended use of a medical device so that it is no longer considered a medical device? From what I can see, the new intended use (developed by our R&D department) results in that the medical device neither can be considered a medical device nor an accessory to a medical device.
Instinctively, it feels wrong to sell a product to a customer saying that you can/may use this product for this purpose, when this is not the same as on the label of the product. Or as R&D put it, if the medical device has intended use X, the new intended use Y is not in conflict with X; it may be considered as a subset/possible use considering the original intended use. Be that as it may, I feel uncomfortable reselling a product with a label that has not changed, i.e. with any text related to our suggested intended use.
How about selling medical devices as a non-medical device? What are the possibilities? Are there any possibilities, or is a medical device always a medical device, regardless of what you call it (If it looks like a duck, swims like a duck, and quacks like a duck, then it probably is a duck…)?
I follow the distributor requirement, but is this also valid if you sell it as something else (i.e. a product that you have determined to not be a medical device, considering the new intended use), and is it at all possible to sell a product as not being a medical device when it has a label (from the original manufacturer) with name, lot nr, exp. date, description, symbols (including the triangle with an “!”) and CE-mark. All of the information on the original label of course still applies (since we do not change the product); could you possibly argue that, for example information related to the manufacturer, is not relevant since it is no longer considered a medical device (by our company, if we resell it with another intended use in mind).
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Hi again,

Many thanks for the valuable feedback.

The issue has taken a new twist…:

What about changing the intended use of a medical device so that it is no longer considered a medical device? From what I can see, the new intended use (developed by our R&D department) results in that the medical device neither can be considered a medical device nor an accessory to a medical device.
Instinctively, it feels wrong to sell a product to a customer saying that you can/may use this product for this purpose, when this is not the same as on the label of the product. Or as R&D put it, if the medical device has intended use X, the new intended use Y is not in conflict with X; it may be considered as a subset/possible use considering the original intended use. Be that as it may, I feel uncomfortable reselling a product with a label that has not changed, i.e. with any text related to our suggested intended use.
How about selling medical devices as a non-medical device? What are the possibilities? Are there any possibilities, or is a medical device always a medical device, regardless of what you call it (If it looks like a duck, swims like a duck, and quacks like a duck, then it probably is a duck…)?
I follow the distributor requirement, but is this also valid if you sell it as something else (i.e. a product that you have determined to not be a medical device, considering the new intended use), and is it at all possible to sell a product as not being a medical device when it has a label (from the original manufacturer) with name, lot nr, exp. date, description, symbols (including the triangle with an “!”) and CE-mark. All of the information on the original label of course still applies (since we do not change the product); could you possibly argue that, for example information related to the manufacturer, is not relevant since it is no longer considered a medical device (by our company, if we resell it with another intended use in mind).
Hi,

You could go down this side road (it's definitely not the highway), but you'd have to follow through with all the consequences. In my opinion the minimum would be relabelling, i.e. removing the original labelling (created under a medical device regulation-set) and applying your own, complying with any applicable rules and regulations for a product not considered a medical device. Further, because the device itself does not change (it's still a duck :)) you'd have to place ample indications (or warnings) that it's use at a "..." (whatever it initially was) is excluded. Better still, I would change it in a way that would preferably prevent (or at least make unlikely) its use as a medical device - make it a lame duck... I realise this may spoil the party, but I think if you don't do it, its use as a medical device (original intent) would be considered a foreseeable, probable misuse, even with the absence of the original labelling, and as such you'd be expected to address it to the regulator's satisfaction.

In short - you probably can do it but it's not that simple.

Cheers,
Ronen.
 
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