We have a similar scenario presently. It was explained by our Notified Body this way:
We, company B, are ISO certified and wish to market company A's device into the EU. However, company A is not ISO certified and wishes not to be (small company with little cash). The Medical Device Directive applies to the device. So: We (company B) are selling (for a profit) the product that company A manufactures within the EU, and thus we (company A) are the responsible party to assure that it complies with all relevant directives. We are required to label the device and identify that we (company B) are the manufacture (however company A really is). I then put the burden back on the manufacture (company A) to create the technical file (under my guidance). Once I proofed and OK'ed the Tech File and performed an on site audit of company A I can create the DoC and apply the CE to the device. We also have contractual agreements with company A with regards to device changes, etc. As long as I do regular audits on company A we are in compliance (according to out Notified Body). Also - company A did apply the safety standards, applicable EMI standards, risk assessment and so on to the device being sold. I hope this does not confuse anyone any more than we already are! -----Original Message----- From: John Woodgate [mailto:j...@jmwa.demon.co.uk] Sent: Tuesday, February 27, 2001 12:38 PM To: emc-p...@majordomo.ieee.org Subject: Re: DoC <EDFA411E5E4AD2118D6F00A0C99E4BAC01DF797E@FLBOCEXU02>, wo...@sensormatic.com inimitably wrote: >Companies A and B are located in the EU. Company A manufacturers a product >and applies the name of Company B. Company B sells the product to a customer >and the product is shipped from Company A direct to the customer. >Which company is responsible for the technical file and issuing the DoC? Company A is the manufacturer and is responsible. Company B may be just a sales unit with insufficient technical knowledge to know whether the DoC is honest or not. But Company A need not put its own name on the DoC. The rules about that vary a bit from one country to another, so the authorities should be contacted. -- Regards, John Woodgate, OOO - Own Opinions Only. Phone +44 (0)1268 747839 Fax +44 (0)1268 777124. http://www.jmwa.demon.co.uk Foxhunters suffer from tallyhosis. PLEASE do not mail copies of newsgroup posts to me. ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ 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: Michael Garretson: pstc_ad...@garretson.org Dave Heald davehe...@mediaone.net For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org All emc-pstc postings are archived and searchable on the web at: http://www.rcic.com/ click on "Virtual Conference Hall," ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ 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: Michael Garretson: pstc_ad...@garretson.org Dave Heald davehe...@mediaone.net For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org All emc-pstc postings are archived and searchable on the web at: http://www.rcic.com/ click on "Virtual Conference Hall,"
