Hi, This is defined in some of the newer directives. i.e. the IVD Directive, 98/79/EC, Article 1, paragraph f. I have to assume that what is a "manufacture" in one directive is the same in all of the other directives. They wouldn't have different definitions, for the same word, in different directives would they? :-)
(f) 'manufacturer' means the natural or legal person with responsibility for the design, manufacture, packaging and labelling 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, fully refurbishes and/or labels one or more ready-made products and/or assigns to them their intended purpose as devices 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; Ned Devine Entela, Inc. Program Manager III Phone 616 248 9671 Fax 616 574 9752 e-mail ndev...@entela.com -----Original Message----- From: acar...@uk.xyratex.com [mailto:acar...@uk.xyratex.com] Sent: Wednesday, December 13, 2000 12:41 PM To: wmf...@aol.com Cc: emc-p...@ieee.org Subject: Re: OEM Issues (EU context) WmFlanigan Our interpretation and how we always treat such issues is, as the seller of the equipment you are responsible to ensure it meets the requirements of the Low Voltage and EMC directive. As you are re badging it, you will need to draw up your own DOCs. Off course you can base your conformity to the directives on the DOC provided with the original product. If you were not re badging, then no new DOC required. Simple rule, if your name is on the front, you are claming responsibility for the product. wmf...@aol.com wrote: > Similar to the 'SAFETY LISTING' thread this week: > > As a manufacturer of electrical equipment, we purchase another manuf's power > supply, CE-marked by them with a copy of their Declaration of Conformance. We > then re-label it with our own label, make only minor physical changes, > document the product and sell it in the EU. In the event that the unit's > conformance to the Electromagnetic Compatibility Directive (89/336/EEC) or to > the Low Voltage Directive (73/23/EEC) is challenged, who is liable to > represent the product? My guess is that we are ast least as responsible as > the 'manufacturer', above, but mine is not a legal opinion. > > Anyone out there (especially on the continent)in a position to offer advice > on how I should proceed? > > Many thanks. > > WmFlanigan > > ------------------------------------------- > This message is from the IEEE EMC Society Product Safety > Technical Committee emc-pstc discussion list. > > To cancel your subscription, send mail to: > majord...@ieee.org > with the single line: > unsubscribe emc-pstc > > For help, send mail to the list administrators: > Jim Bacher: jim_bac...@mail.monarch.com > Michael Garretson: pstc_ad...@garretson.org > > For policy questions, send mail to: > Richard Nute: ri...@ieee.org -- Andrew Carson - Product Safety Engineer Xyratex Engineering Laboratory Tele 023 92496855 Fax 023 92496014 ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson: pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson: pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org
