Can a Distributor Apply for Registration of a Product in the EU

D

drewsky1

#1
This discussion (Canadian Registration & the Responsibilities of Distributors) is similar to a question I have on a device we plan to distribute which is made by another company. We do not own the 510k, they do. My question is if, we, as the distributor can apply for registration of this product in the EU? It would be a Class III device in EU. Would we need to be the manufacturer of the device to do this? Our name is on the label of the distributor.

Thanks
 
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M

MIREGMGR

#2
This discussion is similar to a question I have on a device we plan to distribute which is made by another company. We do not own the 510k, they do. My question is if, we, as the distributor can apply for registration of this product in the EU? It would be a Class III device in EU. Would we need to be the manufacturer of the device to do this? Our name is on the label of the distributor.
I assume you meant "...label as the distributor."

Yes, it's possible for you to market into the EU a device that's made by another company, with the making company having regulatory responsibility for US marketing but your company taking regulatory responsibility for the device in the EU. In my opinion, though, the regulatory hoops you would have to jump through and the level of regulatory cooperation on the part of the original manufacturer to properly do that for an existing MDD Class III device are too difficult for it to make sense. Of course, you might have a higher regulatory pain tolerance than I do. :)

Given that the original manufacturer necessarily would have to be a third-party full participant in EU regulatory compliance in the scenario you outline, perhaps it would be easier for all concerned for them to just get the product EU-accepted on their own. Then all you'd have to do would be distribute it.
 

pkost

Trusted Information Resource
#3
First off, if your supplier has not already got CE marking then I would agree with MIREGMGR, it probably isn't worth the pain and effort for a class III product.

If the supplier does hold a CE mark for the product then there are a number of options open to you and your decision depends on how much pain you can tolerate and how why you want your name on the device

1. Own label.
If you want to be the "manufacturer" and have only your name on the device then this is the way to go. Even though it's a class III because you essentially rely on the original CE mark, it is relatively easy to do. That being said, I wouldn't recommend this route if you do not hold any other CE marks > class 1 and don't have systems in place to meet the requirements of the directive. It will also require a lot of cooperation from your supplier and you should be sure to understand the implications of being the legal manufacturer.

2. Brand the device
If own labelling is unappealing, you can always stick your own name on the device and leave the small print to state who the manufacturer is. As long as the manufacturer is clearly identifiable then there isn't too much of a problem with this, it's best to work with the manufacturer and their notified body to smooth out any wrinkles though. I have in the past seen products were unless you know what you are looking for and looking really hard, you wouldn't be hard pushed to identify the legal manufacturer.
 
D

drewsky1

#4
Thank you. Yes, I did mean "as the distributor", typo. This is good information. What about other international markets like Canada, LAPAC, and Australia. I think Australia may want to have the product CE marked first. Do you have any input on this?
 
D

drewsky1

#5
Thanks for your input. The manufacturer does not have a NB, one of the reasons we may pursue this path.
 
M

MIREGMGR

#6
No NB, therefore no ISO 13485 QS and (probably) no CE certificate, at least not with a scope that could encompass an MDD Class III device...?

A product that probably would be MDD Class III but comes from a company that didn't have an ISO 13485 QS during its development and qualification for the US market, and for which MDD requirements were not addressed on a running basis during that development, is pretty much the worst case from the point of view of your company getting all the ducks in a row to market it in the EU.

Before you could even get started with your NB on developing a mutually acceptable plan for how you'd retroactively qualify the product, you'd have to set yourself up to be able to take Manufacturer responsibility. That's a pretty big step for most companies that have been operating as unregulated distributors. Is that what you had in mind?
 

pkost

Trusted Information Resource
#7
I'm possibly short sighted, but I can see only one reason benefit (albeit a good one) of you CE marking the device - the manufacturer would find it practically impossible to withdraw your distributorship.

Going down the route of your CE marking would significantly change the relationship between the two of you, you would control the product. They would be unable to make any changes without your and the NB's approval, you would have to audit and inspect their facilities to ensure compliance.

As the legal manufacturer, you would be responsible for the device, what if you identified a problem you were concerned about and they didn't agree? They would have to resolve it, but would they be willing?

MIREGMGR has already said you will have a horrendous battle on your hands to get it CE marked as a distributor. If you haven't already, you should also consider how closely it will tie your two companies together and whether both of you are willing to do that!
 
M

MIREGMGR

#8
you would control the product. They would be unable to make any changes without your and the NB's approval
Actually, not control...just have responsibility for. The way this might work in practice is, the other company might make a change to the product or process that would invalidate its regulatory status for Europe.
 

pkost

Trusted Information Resource
#9
Actually, not control...just have responsibility for. The way this might work in practice is, the other company might make a change to the product or process that would invalidate its regulatory status for Europe.
Semantics...certainly the original manufacturer could change the product and invalidate it, but that would be somewhat pointless.

If the legal manufacturer doesn't have control then they would find it very difficult to demonstrate that the product they receive and sell is compliant and would find it equally difficult to receive approval from the NB

At the very least (along the same lines and an own labeled product) they would need a contract in place stating that the original manufacturer wouldn't make any changes without notifying the legal manufacturer. In order for the original manufacturer to continue to market they would have to wait for approval from the legal manufacturer and NB....I would call this control.
 
S

Saratogasix

#10
Without the original manufacturer of the device having a registered 13485 Quality System you are pretty much forced into placing your own CE mark on the device. This would require a good QA/RA Agreement between the two companies that spells out the control and relationships. You will need to create the complete Technical File and recreate the Design History File. The other option would be to use Annex III, EC type Examination coupled with annex IV or V.

Either way this is a tough road to hoe.
 
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