The regulation defines specific responsibilities for each type of economic operator, so you have to be clear about which role you are filling.
'manufacturer' means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trade mark;
'importer' means any natural or legal person established within the Union that places a device from a third country on the Union market;
'distributor' means 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;
'economic operator' means a manufacturer, an authorised representative, an importer or a distributor;
If you are putting your name as manufacturer, then you have all the responsibilities that are assigned to the 'manufacturer' role.
A distributor, importer or other natural or legal person shall assume the obligations incumbent on manufacturers if it does any of the following:
(a) makes available on the market a device under its own name, registered trade name or registered trade mark, except in cases where a distributor or importer enters into an agreement with a manufacturer whereby the manufacturer is identified as such on the label and is responsible for meeting the requirements placed on manufacturers in this Regulation;
(b) changes the intended purpose of a device already placed on the market or put into service;
(c) modifies a device already placed on the market or put into service in such a way that compliance with the applicable requirements may be affected.
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Anne LeBlanc
Manager, Regulatory Affairs
United States
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Original Message:
Sent: 11-Dec-2019 22:56
From: Anonymous Member
Subject: label doubts
This message was posted by a user wishing to remain anonymous
Hi
I have a few doubts for IVD labels
1) If a firm is only a distributor of an IVD product : Whose name (manufacturer) will it appear near the establishment symbol?
( Will it be the OEM address or the distributor address?)
2) Will the rule stay same post IVDR
3) If its not an IVD and its a general purpose item/reagent who's address will be mentioned near the establishment symbol?
4) If the products are manufactured by an OEM supplier can the distributor apply for Certificate of conformity ?
Thanks !