Economic Operator based in UK

Lupop77

Registered
Hi all, apologies if this has been done to death but can anyone offer any clarification on a business based in the UK acting as an Importer of a medical device from a third country?

The definition of an Importer in the MDR states: "importer" means any natural or legal person established within the Union that places a device from a third country on the Union Market: "

Now that the UK has left the Union and is considered a third country for MDR, is it possible for us to still act as an importer? What is the role if we buy from a third country and sell back into the EU; USA to UK to Germany for example? I literally can't find a thing that clearly explains or clarifies the Importer role when buying third country to third country and then exporting back in to the EU! I know this wouldn't be an issue if we were only supplying the purchased goods within the UK but we export back into the EU so the goods we buy must be MDR compliant and our role defined as if we are/can be classed as an importer am I right in thinking we then need an EU Authorised Rep and Eudamed registration? Anyone have any experience of this or have any useful links/contacts for advisors?
 

Awadine

Involved In Discussions
As I understand it you are a UK Importer but can not be the EU Importer. In the example you gave (UK to Germany) then the German entity would probably be the importer. As the definition states, the EU importer must be established in the EU.

An authorised rep in the EU will be required if the manufacturer is based in a Third Country and yes, the manufacturer, authorised rep and importer will all need to be registered in Eudamed.
 

Lupop77

Registered
Thanks so much, you wouldn't know how selling to an end user in the EU would work would you? The end user would not necessarily be the Importer in that instance as we would be selling to many customers.

We have a distributor agreement with a manufacturer in a third country, we would be their UK importer with permissions to export into the EU...this is the part I'm really struggling with. The manufacturer has already registered with Eudamed via their EU Authorised Rep and they have a UK Rep in place, does this satisfy all of the requirements or would there still have to be a registered "Importer" to receive the goods into the EU? If we are the Importer for the UK, I'm just a little unsure as to what our responsibilities are for exporting the product to place it on the EU market...
 

Awadine

Involved In Discussions
Hi

From the information provided, it looks like you will be distance selling into the EU then, if you sell direct to a customer from the UK with no EU entity involved.

I am not sure how that would work. Does the manufacturer have an EU importer?

Hopefully someone who knows more about distance selling will be along shortly with some good advice .
 

Lupop77

Registered
Thanks for taking the time to provide this info :)

I don't think the manufacturer does have an EU Importer as we have always been their distributor into the EU, its just that MDR (and Brexit!) has changed all of this - I'm hoping someone can give me definitive advice or recommend an advisory company on selling the devices into the EU from the UK as we will have the responsibility to ensure they are MDR compliant. I'm clear on the responsibilities that come with each EO status, I'm just really unclear on whether or not we are classed as placing the device on the Union market if we are as you mention distance selling to an end user.
 

Raisin picker

Quite Involved in Discussions
I Think MDR is here quite clear: Article 2 (33):
‘importer’ means any natural or legal person established within the Union that places a device from a third country on the Union market;
You are based in UK, you cannot be importer. You need someone based in EU for the role of importer.
 

Lupop77

Registered
Thanks, this is my understanding of the MDR however a colleague has raised that we can act as an Importer?! I'm thinking we might be more going down the line as being UK Importer and a distance seller now that I have looked into this thanks to the poster above, we sell to end users and so I think Article 6 is applicable to us.
 
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Alan_DB

Involved In Discussions
I cannot post a link so I will DM you link to MHRA guidance, but my understanding yes EU AR can be based in NI.
 
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