Help Understanding Current Role; Distributor, Manufacturer, or Importer

[RooteronaScooter]

Hi!

Not new to the forums, I've been around since 2009, but I've been able to get my questions answered looking through everyone else's questions and comments, so I tend to lay low and observe. Anyway, I'm a huge fan of the forums, super glad it exists and is frequented by some great folks.

I work for a medical device manufacturer in the US (class 1 devices). We are currently working toward EUMDR compliance so we can market our products in the EU. We found a device manufacturer in Germany (off the shelf class 1r devices) we would like to purchase from in order to round out our line of products (private label scenario). These devices would also be marketed in EU countries along with our own. In conversation with them, they had mentioned that for them to CE mark the devices, we as the "manufacturer", would need to provide for all the documentation, clinical work, etc. This doesn't seem right to me, but I've been wrong before when it comes to confusing legislation and regulations (crow is a familiar taste).

I am under the impression we would be the distributor, as we would do nothing to modify the actual device(s); we would package the devices in bags using our own label with all the relevant data fields of course. And so they would be considered the manufacturer and whatever entity we market through in the EU would be considered the Importer. Can anyone either confirm this will be the case or, if not, point me in the direction where I can get some clarification? We are still in conversation with the manufacturer and I'm attempting to get clarification from them as well, but it's been slow coming.

Thank you!
Beej

 

[Billy Milly]

The main question here is who will be labelled as a manufacturer on the device and who will obtain the CE certification. If this is you, the explanation above is applicable - you have to hold all relevant documentation for certification. If this is your partner, they produce under their CE and your brand; you are a distributor.

 

[Jean_B]

What was Own Brand Labeling and is now called Virtual Manufacturing doesn't function like you thought in the EU (and has not been for some while, though the EU MDR added further detail).
I can't summarise it as well as this article does: Why Virtual Manufacturing Is Likely To Be Less Popular Under EU’s New Device Regulations :: Medtech Insight (informa.com)

 

[Raisin picker]

Or to put it in other words, MDR allows for two scenarios:

1. You are named as manufacturer on the label, your partner is a "critical supplier". You are legal manufacturer, you are responsible for everything.
2. You are named on the label, but your partner is named as "manufactured by" on the label as well. Then your role is distributor. The partner includes you as a "tradename" in his file. He still retains all manufacturer responsibilities, with you having distributor responsibilities. This is detailed in an appropriate contract.

Read the MDR. Then read articles 13++, especially article 16.

The system under MDD, where responsibilities were shared and divided until noone was responsible for anything, is gone for good.

... as we would do nothing to modify the actual device(s); we would package the devices in bags using our own label ...

Since the label is part of the device, you actually do modify the device here.

 

[RooteronaScooter]

I can't summarise it as well as this article does: ...

Great article, thank you!

 

[DannyVerbiest]

Or to put it in other words, MDR allows for two scenarios:

1. You are named as manufacturer on the label, your partner is a "critical supplier". You are legal manufacturer, you are responsible for everything.
2. You are named on the label, but your partner is named as "manufactured by" on the label as well. Then your role is distributor. The partner includes you as a "tradename" in his file. He still retains all manufacturer responsibilities, with you having distributor responsibilities. This is detailed in an appropriate contract.

Read the MDR. Then read articles 13++, especially article 16.

The system under MDD, where responsibilities were shared and divided until noone was responsible for anything, is gone for good.


Since the label is part of the device, you actually do modify the device here.

Great summary, raisin picker!
Do you know if the MDD method (with OEM and OBL) is still possible during the transition period?

 

[Aliken]

According to MDR Article 16, obligations of manufacturers (like CE certification) apply to distributors when the distributor makes available on the market a device under its name, registered trade name, or registered trade mark, except in cases where a distributor… enters into an agreement with a manufacturer whereby the manufacturer is identified as such on the label and is responsible for meeting the requirements placed on manufacturers according to MDR.

 

[marwa]

Great summary, raisin picker!
Do you know if the MDD method (with OEM and OBL) is still possible during the transition period?

Or to put it in other words, MDR allows for two scenarios:

1. You are named as manufacturer on the label, your partner is a "critical supplier". You are legal manufacturer, you are responsible for everything.
2. You are named on the label, but your partner is named as "manufactured by" on the label as well. Then your role is distributor. The partner includes you as a "tradename" in his file. He still retains all manufacturer responsibilities, with you having distributor responsibilities. This is detailed in an appropriate contract.

Read the MDR. Then read articles 13++, especially article 16.

The system under MDD, where responsibilities were shared and divided until noone was responsible for anything, is gone for good.


Since the label is part of the device, you actually do modify the device here.

So under artica 16 if I am disturbed I can add my addresss