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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
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