Dave, The person ‘authorised to compile the technical file’ does not have to be the Authorised Representative. The manufacturer’s DofC signatory does not have to be located within the EU.
Our explanatory pages at www.doceupoint.eu may help to clarify the requirements. [Apologies if the latter point is seen to be advertising, but the pages in question directly address the OPs questions and I think it is more appropriate to provide a web link than to paste the content here]. Regards Nick. On 27 Feb 2014, at 18:32, Nyffenegger, Dave <dave.nyffeneg...@bhemail.com> wrote: > Hello PSES Forum, > > I'm looking for some feedback interpreting the DIRECTIVE 2006/42/EC OF THE > EUROPEAN PARLIAMENT AND OF THE COUNCIL of 17 May 2006. > > Article 3 defines: > > "(i) 'manufacturer' means any natural or legal person who designs and/or > manufactures machinery or partly completed machinery covered by this > Directive and is responsible for the conformity of the machinery or the > partly completed machinery with this Directive with a view to its being > placed on the market, under his own name or trademark or for his own use. In > the absence of a manufacturer as defined above, any natural or legal person > who places on the market or puts into service machinery or partly completed > machinery covered by this Directive shall be considered a manufacturer; > > (j) 'authorised representative' means any natural or legal person established > in the Community who has received a written mandate from the manufacturer to > perform on his behalf all or part of the obligations and formalities > connected with this Directive;" > > ANNEX II declares > > "The EC declaration of conformity must contain the following particulars: > ........ > 2. name and address of the person authorised to compile the technical file, > who must be established in the Community; > ......... > 10. the identity and signature of the person empowered to draw up the > declaration on behalf of the manufacturer or his authorised representative." > > It's not clear to me if " the person authorised to compile the technical > file" is intended to be one and the same as 'authorised representative' or > not. > > I have often heard the that signature on the DoC also needed to come from a > member of the Community. The way I read the directive that is only the case > for " or his authorised representative." The Directive also states the > signature can be the "person empowered to draw up the declaration on behalf > of the manufacturer ." There is nothing in the declaration that requires the > manufacturer or person empowered by the manufacturer to be a member of the > Community. > > Does anyone know if there have been any further clarifications or > interpretations on this? > > David P. Nyffenegger, PMP, SM-IEEE > Product Development Manager > Bell and Howell > 3791 South Alston Avenue > Durham, NC 27713 > Phone: 919.767.6419 > Web: www.bellhowell.net > Nick Williams Director Direct line: +44 1298 873811 Mobile: +44 7702 995135 email: nick.willi...@conformance.co.uk ----- Conformance Ltd - Product safety, approvals and CE-marking consultants The Old Methodist Chapel, Great Hucklow, Buxton, SK17 8RG England Tel. +44 1298 873800, Fax. +44 1298 873801, www.conformance.co.uk Registered in England, Company No. 3478646 - ---------------------------------------------------------------- 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 <emcp...@radiusnorth.net> Mike Cantwell <mcantw...@ieee.org> For policy questions, send mail to: Jim Bacher: <j.bac...@ieee.org> David Heald: <dhe...@gmail.com>
