What is required in terms of the DHR, DMR, DHF?

V

vw08417n

#1
I work for a medical device organization and I am having just slight difficulty in making sure I am following the correct procedure regarding DHF, DMR, and DHR's. Our organization currently has a lot of products, some we manufacturer, some we import into the US, some we distribute, what is required in terms of the DHR, DMR, DHF?

From my knowledge, for all products we manufacture we would require all 3 (DHF, DHR and DMR). For all products we import, which one should we maintain? For products we distribute, which should we maintain?
 
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Ronen E

Problem Solver
Moderator
#2
Hello and welcome to the Cove :bigwave:

I'll assume that by "distribute" you mean buy on-shore and on-sell devices that don't bear you company's name and/or where you don't own the design, where you are not the regulatory-responsible Manufacturer. For such devices you definitely don't need a DHF or a DMR. You also don't need a DHR, but in some situations it might be handy to have a copy or at least some parts of it.

For devices you manufacture you definitely need a DMR and a DHR. A DHF would also be necessary if your company designed the device, or was responsible for the design / had it designed for under contract. Even if the design is not yours you might need access to the DHF, either as in maintaining a current copy or having contracted arrangements to access it through the design owner. I'm not going to list down all the possible collaboration scenarios because they're limited only by business imagination. If you explain your situation in more detail I might be able to be more specific.

Imporeted devices should generally be treated as either "yours" (similar to devices you manufactured), eg where they are private-labeled, or as distributed only devices, though you'd probably need a copy of the DHR in case there are issues at the point of entry (depends on the device risk level and various other factors). Again, some specifics might allow a more definite response.

Cheers,
Ronen.
 
V

vw08417n

#4
Marc,

Specifically, we have a company that we import their products from Belgium (Dental Implants). The products are not manufactured by us, nor designed by us, however we are the only distribution in the US. Therefore, as far as regulations, I wanted to ensure that I maintained the proper paperwork on file.
 

Ronen E

Problem Solver
Moderator
#5
Marc,

Specifically, we have a company that we import their products from Belgium (Dental Implants). The products are not manufactured by us, nor designed by us, however we are the only distribution in the US. Therefore, as far as regulations, I wanted to ensure that I maintained the proper paperwork on file.
Is it an Own Brand Label (OBL) or is it "their" device?

If the Belgian manufacturer's name and address appear on the labeling and your company's name and address don't, or they only appear in addition to the manufacurer's details (without obscuring any meaningful labeling element), while unambiguously highlighting that your company is merely a distributor, then you're probably exempt from the main regulatory responsibility. In that case you don't need to maintain a DHF or a DMR. However, you still have to meet the requirements applicable to Initial Importers.
 
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