MDSW Software importer distributor

Mga_MD

Starting to get Involved
#1
Hi,

I hope this forum trend can help me on two questions related with Importerns and Distributors

- A company form the US is planning to comerzialise a software (SW) considered a MD (MDSW) in the EU. The Software is not provided in any physical mean.

Do they need an importer or a distributor to act as Economic Operators of the MDSW?

Thanks in advance
 
Elsmar Forum Sponsor

Mga_MD

Starting to get Involved
#2
Hi,

I hope this forum trend can help me on two questions related with Importerns and Distributors

- A company form the US is planning to comerzialise a software (SW) considered a MD (MDSW) in the EU. The Software is not provided in any physical mean.

Do they need an importer or a distributor to act as Economic Operators of the MDSW?

Thanks in advance

I don't know if someone could help me on this topic. thanks a lot!
 

Junn1992

Quite Involved in Discussions
#3
Do they need an importer or a distributor to act as Economic Operators of the MDSW?
Under the MDR, the manufacturer itself, whether located in the EU or not, is an economic operator. Since the manufacturer in this case is located in US, it will require an authorised representative in the EU.

Do they need an importer or distributor? Depends. If they register a EU branch/subsidiary, that branch/subsidiary becomes the importer/distributor. If they choose to sell through an importer/distributor, then that particular importer/distributor becomes economic operator and assumes responsibilities of the importer/distributor under the MDR.

‘economic operator’ means a manufacturer, an authorised representative, an importer, a distributor or the person referred to in Article 22(1) and 22(3);
 
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