In message <p06240801c46a9cb4a264@[192.168.1.30]>, dated Tue, 3 Jun 2008, Nick Williams <[email protected]> writes:
>We have, in the past, been told by the MHRA (the enforcing body for the >Medical Devices Directive in the UK) that we were not allowed to put >the year number on DofC's because it might be confused with the >notified body (NB) number for a product where the NB number is a >requirement (i.e. where the manufacturer's quality system has to be >assessed). This was for a two digit year number so I imagine they'd >take a very dim view of the use of four digits (since this is the >standard format for a notified body number). > >Our (unofficial) response to this was to conclude that the MHRA don't >know the rules which apply to products which are not medical devices >very well, and to ignore them in these cases. However, we do take care >to ensure the digits are not present on DofCs for medical devices - the >MDD and the directives which require the digits of the year are >mutually exclusive so this is the correct approach. 'Mutually exclusive', so it's perhaps not surprising that the requirements for the content of DoCs differ between the MDD and the LVD. But it does seem to be illogical, like so much in EU legislation. A more fundamental question is 'What is the reason for requiring the two digits to be included?' It is also far from clear what 'first affixed' means, when you take into account engineering changes in the product, changes in the edition of the safety standard which is valid, changes in the Directive which applies... For example, products now having a DoC referring to 2006/95/EC may have had the CE mark first affixed under Directive 73/23/EEC. Is that the required date, or that on which the CE mark was 'first affixed' under 2006/95/EC? In view of all these uncertainties, I think it's not surprising that many DoCs do not include the date. -- OOO - Own Opinions Only. Try www.jmwa.demon.co.uk and www.isce.org.uk Either we are causing global warming, in which case we may be able to stop it, or natural variation is causing it, and we probably can't stop it. You choose! John Woodgate, J M Woodgate and Associates, Rayleigh, Essex UK - This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. Website: http://www.ieee-pses.org/ To post a message to the list, send your e-mail to [email protected] Instructions: http://listserv.ieee.org/request/user-guide.html List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas [email protected] Mike Cantwell [email protected] For policy questions, send mail to: Jim Bacher: [email protected] David Heald: [email protected] All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
