Mark, I assume that you mean Class 1 according to the EU's Medical Devices Directive, and not the FDA classification. Although the principle is the same, i.e. Class 1 is low-risk, the classification method is not identical.
The MDD deals with the device rather than the distributor. Compliance of the device with the MDD is mandatory. You should probably check the Health Ministry or 'Competant Authority' (as defined in the MDD), to check whether there are requirements on the distributor. As this subject is not covered by the MDD, the regulations are likely to be different in each country of the EU. You can contact the UK Competent Authority via their website at: http://www.medical-devices.gov.uk/ Distributors would certainly be obligated to report incidents involving injury or death to the authorities. I hope this helps. Jon Griver http://www.601help.com The Medical Device Developer's Guide to IEC 60601-1 On 18 Sep 2002 at 8:11, Mark Schmidt wrote: > > Hello Group, > > Are there any requirements for European Distributors of Medical Devices, i.e. > license or registration. The Device in question is a Class 1 device. > > Thank you. > > Mark Schmidt > Regulatory Compliance > X-Rite Incorporated > Grandville, MI > USA > (616) 257 2469 > mschm...@xrite.com > > > ------------------------------------------- > 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: > Ron Pickard: emc-p...@hypercom.com > Dave Heald: davehe...@attbi.com > > 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://ieeepstc.mindcruiser.com/ > Click on "browse" and then "emc-pstc mailing list" > ------------------------------------------- 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: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com 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://ieeepstc.mindcruiser.com/ Click on "browse" and then "emc-pstc mailing list"
