I recently participated in a Notified Body audit at a medical device manufacturer. The manufacturer had a single Declaration of Conformity for the MDD and RoHS.
The auditor told the manufacturer to separate the Declarations. The reason given was that the Notified Body's name and number appear on the MDD Declaration, and if the RoHS Declaration was included in the same Declaration, then it may be assumed that the Notified Body was involved in the supervision of the manufacturer's compliance with RoHS, which it is not. Jon Griver www.601help.com -----Original Message----- From: Nyffenegger, Dave [mailto:dave.nyffeneg...@bhemail.com] Sent: Friday, 6 November, 2015 06:38 To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: Re: [PSES] One DoCs vs multiple DoCs The EC Blue Guide says "Where several pieces of Union harmonisation legislation apply to a product, the manufacturer or the authorised representative has to provide a single declaration of conformity in respect of all such Union acts190. It is accepted that the single declaration may be a dossier made up of relevant individual Declarations of conformity." -Dave -----Original Message----- From: T.Sato [mailto:vef00...@nifty.ne.jp] Sent: Thursday, November 05, 2015 5:37 PM To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: Re: [PSES] One DoCs vs multiple DoCs On Thu, 5 Nov 2015 19:51:03 +0000, "Kunde, Brian" <brian_ku...@lecotc.com> wrote: > With the RoHS Directive kicking in at different times for different Categories of products, I'm starting to see the RoHS Directive listed on Declaration of Conformities. However, I have also noticed many companies generating two different DoCs; one for Safety and EMC and the other for RoHS only. > > Can someone explain to me chapter and verse on the EU's position regarding multiple DoCs? > > Our company's product category will soon be applicable to RoHS and we would like to know if multiple DoCs are OK to do or not. I've heard Not, but then again, I see reputable companies doing it so what's the deal? Maybe it is under the manufacture's choice. However, recent directives such as 2014/30/EU and 2014/35/EU says: "... a single EU declaration of conformity shall be drawn up in respect of all such Union acts." Regards, Tom - ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to <emc-p...@ieee.org> All emc-pstc postings are archived and searchable on the web at: http://www.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/ Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe) List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <sdoug...@ieee.org> Mike Cantwell <mcantw...@ieee.org> For policy questions, send mail to: Jim Bacher: <j.bac...@ieee.org> David Heald: <dhe...@gmail.com> - ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to <emc-p...@ieee.org> All emc-pstc postings are archived and searchable on the web at: http://www.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/ Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe) List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <sdoug...@ieee.org> Mike Cantwell <mcantw...@ieee.org> For policy questions, send mail to: Jim Bacher: <j.bac...@ieee.org> David Heald: <dhe...@gmail.com> - ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to <emc-p...@ieee.org> All emc-pstc postings are archived and searchable on the web at: http://www.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/ Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe) List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <sdoug...@ieee.org> Mike Cantwell <mcantw...@ieee.org> For policy questions, send mail to: Jim Bacher: <j.bac...@ieee.org> David Heald: <dhe...@gmail.com>
