More than one importer for the same device

kreid

Involved In Discussions
#1
Hello, Is it possible under EU MDR 2017/745, for more than one importer to import the same device from a 3rd party country? Any references / source information for the answer would be appreciated
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Hello, Is it possible under EU MDR 2017/745, for more than one importer to import the same device from a 3rd party country? Any references / source information for the answer would be appreciated
Yes, it's possible.
Why don't we start with you posting any references / sources of information that indicate otherwise?
 

kreid

Involved In Discussions
#3
Thanks for your charming response.
I have been asked the question and do not know of any reason why it is not possible (though I do find the EU MDR difficult to interpret) but if someone were to offer a reason I would like to add some references for when I give the answer.
 

dgrainger

Trusted Information Resource
#4
Sort of implied in Article 10.12:

12. Manufacturers who consider or have reason to believe that a device which they have placed on the market or put into service is not in conformity with this Regulation shall immediately take the necessary corrective action to bring that device into conformity, to withdraw it or to recall it, as appropriate. They shall inform the distributors of the device in question and, where applicable, the authorised representative and importers accordingly.​

You may have multiple distributors and importers but only one authorised representative.
 
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