EU-MDR: Complicated supply chain

[UNIJP]

Hey, y'all. I need your help to sort out a complicated supply chain in regard to Article Article 10, 13, 14, and 22.
Currently, my company (A), a manufacturer outside of the Union. We supply CE class IIa devices to a trading company (B) in the Union. The company sells the products to several procedure pack manufacturers in the EU (C).

Given that procedure pack is manufactured accordingly to Article 22, what is the role of each economic operator in this case?

A: legal manufacturer
B: Importer, or no role under MDR applicable?
C: Importer, or manufacturer?

 

[J0anne]

Hey, y'all. I need your help to sort out a complicated supply chain in regard to Article Article 10, 13, 14, and 22.
Currently, my company (A), a manufacturer outside of the Union. We supply CE class IIa devices to a trading company (B) in the Union. The company sells the products to several procedure pack manufacturers in the EU (C).
Given that procedure pack is manufactured accordingly to Article 22, what is the role of each economic operator in this case?

A: legal manufacturer
B: Importer, or no role under MDR applicable?
C: Importer, or manufacturer?

Your question isn't clear

A: could be the supplier, the manufacturer, distributor or the importer etc
It depends what you all do specifically

B: Yes everyone in the supply chain has responsible role but again, without knowing the details it would be hard to tell

C could be anyone of those, or a large retailer like Amazon

Or are you telling us A is the manufacturer etc and you want know their roles and responsibilities?

 

[UNIJP]

Your question isn't clear

A: could be the supplier, the manufacturer, distributor or the importer etc
It depends what you all do specifically

B: Yes everyone in the supply chain has responsible role but again, without knowing the details it would be hard to tell

C could be anyone of those, or a large retailer like Amazon

Or are you telling us A is the manufacturer etc and you want know their roles and responsibilities?

Thank you J0anne for your responses.
I want to know which economic operator role(s) is applied to each company (A, B, and C) in this supply chain.

Let me try to make it clear.

Company A: located outside the union, manufactures the CE marked medical device and export to company B.
Company B: located inside the union, import the product and distribute it to company C
Company C: located inside the union, manufacture procedure pack accordingly to article 22

 

[ond1n3]

Attention - importer of a device from a customs and tax standpoint or even physical flow, doesn't equal importer under EU MDR! Company B 's role needs to be defined by you from an EU MDR perspective. Hope it helps.

 

[Nicky]

Hi,

Can I please get some clarity on this situation. My company is a manufacturer based in England and export directly to a hospital in Northern Ireland. According to the MDR, would the hospital being the end user need to meet any requirements. would they be the importer? Would there be an importer if the product is directly exported from England to the Northern Ireland?