MDR Distributor

[fialor]

Hello, Colleagues.
I have been asked a question on distributors under the MDR and I cannot find a clear answer.
Or it may not exist but it would be great to hear your thoughts as well.

Does the MDR require the distributor to be based in the EU?

By virtue of the fact that the distributor only distributes what is imported by the Importer ("...established within the union..." as defined by article 2(33)), it seems logical to me to deduce that the distributor is seen as one who is established within the union.

However, other than the definition of "...in the supply chain..." I have not found anything that sheds light on whether the distributor is required to be established in the union. The blue book, MDCG 2021-27, and MDCG 2021-23 do not shed any light on this for me.

Thank you!

 

[fialor]

Hello, Colleagues.
I have been asked a question on distributors under the MDR and I cannot find a clear answer.
Or it may not exist but it would be great to hear your thoughts as well.

Does the MDR require the distributor to be based in the EU?

By virtue of the fact that the distributor only distributes what is imported by the Importer ("...established within the union..." as defined by article 2(33)), it seems logical to me to deduce that the distributor is seen as one who is established within the union.

However, other than the definition of "...in the supply chain..." I have not found anything that sheds light on whether the distributor is required to be established in the union. The blue book, MDCG 2021-27, and MDCG 2021-23 do not shed any light on this for me.

Thank you!

Anyone with to share?

 

[Cybel]

In my opinion, if a distributor is not established in the EU, he is outside the supply chain as described in MDR.
In fact, what happens when he distributes a medical device in the European market? The company/person receiving the medical device becomes the importer. Everyone afterwards is another EU distributor.

 

[fialor]

In my opinion, if a distributor is not established in the EU, he is outside the supply chain as described in MDR.
In fact, what happens when he distributes a medical device in the European market? The company/person receiving the medical device becomes the importer. Everyone afterwards is another EU distributor.

Thanks Cybel.
I guess the challenge is that the it is not stipulated that the supply chain must reside within the EU; distributors external to the EU could exist with non-EU addresses using transport companies to progress the chain once an importer has imported the product.

 

[Billy Milly]

I agree with Cybel's view. If the distributor is not located in the EU, he exports the device when purchasing it (transferred ownership of the device).

 

[Cybel]

Thanks Cybel.
I guess the challenge is that the it is not stipulated that the supply chain must reside within the EU; distributors external to the EU could exist with non-EU addresses using transport companies to progress the chain once an importer has imported the product.

Yes, but in this case this non EU distributor is not subject to MDR. Other EU distributors in the supply chain will be subject to MDR instead.
So, maybe the issue is not "Does the MDR require the distributor to be based in the EU?" but "Does the MDR apply to non EU distributors?" and answer is not, it doesn't.

 

[goldenguo]

I like Cybel’s smart reply.

(34) ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service;

I think for distributors MDR do not care this role too much, you know manufacture and Importer need keep contact with them. MDR give many job to importer, and need to register in Eudamed and link to manufacturer.

in case a non EU company buy a device from EU importer , there are 2 options:
1- he sell out of EU, for this I think MDR will not care it at all. If he sell to UK, MHRA will take care of it.
2- he sell in EU
In this situation, I think MDR will trade it same as EU distributors.