Hi, I don't have any information on other directives, but the Medical Device Directive (93/43/EEC), Article 1, clause f, has a definition of the manufacture (see below).
What it basically means is that if your name is on the device, you are considered the manufacture. As the manufacture you are responsible for the conformity of the device to all applicable directives (i.e. you issue the DoC). You of course can reference the OEM's technical file(s) in your technical file. We just require/suggust you to have contractual agreements for access to these files. In order to avoid confusion, we do not allow products to be marked "device A, made by B", or "device A made by B for C", or "device A made for B", or "device A distributed by B", or similar wording. Ned Devine TUV Product Service [email protected] (f) 'manufacturer' means the natural or legal person with responsibility for the design, manufacture, packaging and labeling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party. The obligations of this Directive to be met by manufacturers also apply to the natural or legal person who assembles, packages, processes, full refurbishes and/or labels one or more ready-made products and/or assigns to them their intended purpose as a device with a view to their being placed on the market under his own name. This subparagraph does not apply to the person who, while not a manufacturer within the meaning of the first subparagraph, assembles or adapts devices already on the market to their intended purpose for an individual patient; ------------- Original Text From: [email protected], on 04/18/1997 11:01 AM: To: <[email protected]> I have been asked to look into the details of private-labelling a stand-alone OEM product on which the OEM places the CE Mark and for which the OEM has issued a Declaration of Conformity. If we have the OEM put our name on this product, but do not issue our own DofC, does the actual manufacturer's name have to appear somewhere on the product or packaging? In other words, does the EU want to be able to trace the actual manufacturer just from looking at the product itself at the user or retail level? Where is this addressed: in the Directives? I have checked 93/68/EEC, 89/336/EEC, and 73/23/EEC and find no requirement that a mfr's name accompany the CE mark on the product. Thanks in advance for your help, Jim Eichner Statpower Technologies Corporation [email protected] Any opinions expressed are those of my invisible friend
