Hello all,
I am struggling to fully understand the Importer definition as stated in the MDR;
(33) ‘importer’ means any natural or legal person established within the Union that places a device from a third country on the Union market
(28) ‘placing on the market’ means the first making available of a device, other than an investigational device, on the Union market;
(27) ‘making available on the market’ means any supply of a device, other than an investigational device, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;
According to the blue guide;
“the placing on the market is the moment in which the
product is supplied for distribution, consumption or use for the purposes of compliance
with Union harmonisation legislation”.
So all in the context of a commercial activity between parties, transferring the ownership of a product.
To define the importer role,
a) do you need to identify the location of the legal manufacturer of the products as indicated on the label
b) identify the legal location of the natural or legal person you are doing business with
c) identify the physical location from where the products are transferred from
Thank you for helping!
I am struggling to fully understand the Importer definition as stated in the MDR;
(33) ‘importer’ means any natural or legal person established within the Union that places a device from a third country on the Union market
(28) ‘placing on the market’ means the first making available of a device, other than an investigational device, on the Union market;
(27) ‘making available on the market’ means any supply of a device, other than an investigational device, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;
According to the blue guide;
“the placing on the market is the moment in which the
product is supplied for distribution, consumption or use for the purposes of compliance
with Union harmonisation legislation”.
So all in the context of a commercial activity between parties, transferring the ownership of a product.
To define the importer role,
a) do you need to identify the location of the legal manufacturer of the products as indicated on the label
b) identify the legal location of the natural or legal person you are doing business with
c) identify the physical location from where the products are transferred from
Thank you for helping!