Stephen,
At this stage, the version of ISO 13485 required for approval to the Medical Devices Directive is EN ISO 13485:2012. The body of this standard is identical to ISO 13485:2003, and there are some additional EU appendices. I have heard from at least one Notified Body that they will not be accredited to audit to ISO 13485:2016 until the start of 2018, so at the moment you can't claim compliance to this standard alone. However, the solution is quite simple. You prepare the quality manual and procedures to ISO 13485:2016 and operate the quality system according to its requirements. You also make sure that the quality system is also compliant with ISO 13485:2003 and EN ISO 13485:2012. That's shouldn't be difficult, as the differences are minor. Then, in the scope section of the Quality Manual, you state that the quality system is intended to comply with ISO 13485:2003, EN ISO 13485:2012 and ISO 13485:2016, together with whatever other regulatory requirements you need. Regards, Jon Griver http://www.601help.com The Medical Device Designer's Guide to IEC 60601-1 From: Stephen Whalen [mailto:scwha...@bellsouth.net] Sent: 18 January 2017 17:17 To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: [PSES] ISO 13485-2016 All, I am helping a client with medical device manufacturing QMS. ISO 13485 - 2016 has been released however 2016 version is not listed as harmonized with EU. Does anyone know if 2016 version is acceptable now for CE approval? https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en Regards, Stephen - ---------------------------------------------------------------- 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 <mailto: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) <http://www.ieee-pses.org/list.html> List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <sdoug...@ieee.org <mailto:sdoug...@ieee.org> > Mike Cantwell <mcantw...@ieee.org <mailto:mcantw...@ieee.org> > For policy questions, send mail to: Jim Bacher <j.bac...@ieee.org <mailto:j.bac...@ieee.org> > David Heald <dhe...@gmail.com <mailto: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>
