Hi all,
I would like to clearly understand the differences between an Importer and Distributor, according to the definitions in the new MDR.
Importer: any natural or legal person established within the Union that places a device from a third country on the Union market;
- where "placing on the market" is defined as the first making available of a device, other than an investigational device, on the Union market
Distributor: any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service;
- where "making available on the market" is defined as 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
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For example, let's suppose a European company BBB wants to sell the medical device XYZ, manufactured outside the EU by the manufacturer AAA, and bought by BBB from this manufacturer AAA.
Company BBB is the importer.
If the device XYZ is sold by BBB to another Company CCC, this Company CCC is then the distributor.
If subsequently a Company DDD wants to sell the SAME medical device XYZ, buying it directly from the manufacturer BBB, is the Company DDD a new importer (with a new EUDAMED registration as required by the MDR) or it is just a distributor?
Enclosed you can find an image that summarizes what stated above.
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Andrea Duca
Albano Laziale
Italy
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