Any of you documenting the same product as IVD and non-IVDequipment?

[Corcoran, Susan]

Hi Verner,

What I'm trying to determine is whether you could put the symbol on the
book and have a null effect.  Similar to when I publish a C-Tick symbol
in my manuals.  Only Australia uses that symbol, so it has a null effect
for any other country.  Therefore, it can go in every manual and I don't
have to create a new, Australia-only, version of the manual.  If the IVD
symbol won't signify anything in other countries, then you'd be safe to
put it on and print for all countries.  But if it indicates compliance
with a standard that has *not* been met in other countries, then I think
you'd have to create a different manual for the US market only.  
 
- Susan

> -----Original Message-----
> From: Andersen, Verner Engell VEA
[mailto:verner.andersen at radiometer.dk]
> Sent: Wednesday, October 01, 2008 9:56 AM
> To: Corcoran, Susan
> Subject: RE: Any of you documenting the same product as IVD and non-
> IVDequipment?
> 
> Hi Susan
> 
> IVD stand for In Vitro Diagnostics. In USA FDA considers our software
> product a patient diagnostics system and consequently we must have the
> IVD symbol on the manual. The rest of the world does not consider our
> product IVD equipment, so we don't need the symbol on their manuals.
> 
> Our hardware product is considered an IVD product all over the world,
so
> here we can use the same manual for say UK and the USA.
> 
> Best regards,
> 
> Verner
> 
> 
> --------------------------------------------------------
> 
> 
> 
> Radiometer Medical ApS
> Akandevej 21
> 2700 Bronshoj
> Denmark
> Phone: +45 38 27 38 27
> CVR: 27 50 91 85
> 
> --------------------------------------------------------
> 
> 
> 
> 
> 
> 
> 
> 
> 
> -----Original Message-----
> 
> From: Corcoran, Susan [mailto:Susan.Corcoran at Honeywell.com]
> Sent: 1. oktober 2008 15:42
> To: Andersen, Verner Engell VEA; framers at lists.frameusers.com;
> FrameMaker discussion list (omsys) (FrameMaker discussion list(omsys))
> Subject: RE: Any of you documenting the same product as IVD and
> non-IVDequipment?
> 
> Hello Verner,
> 
> I create a regulatory insert sheet for my company's products.  Many of
> the logos, such as the GS mark, C-Tick, or NOM apply only to certain
> countries.  Is that what an IVD symbol is?  Do you mean that the LVD
is
> only applicable in the US (other countries don't use this standard),
or
> that the LVD only approved for the US (you don't have approval in
other
> countries)?
> 
> - Susan
> 
> > -----Original Message-----
> > Subject: OT: Any of you documenting the same product as IVD and non-
> > IVDequipment?
> >
> > Hi
> >
> > I just found out that my product manual should be marked with the
IVD
> > symbol for US customers. For the rest of the world the IVD doesn't
> > apply.
> >
> > The current solution is to have the same manuals in two versison one
> > with and one without the IVD logo on the rear page. That means two
> order
> > numbers, additons to price lists, two brochures, two CDs with the
> manual
> > etc.
> >
> > Do any of you know of an operational way of handling this?
> >
> > My first suggestions was to have 1 manual and in front of or above
the
> 
> > IVD logo have something like "applicable to the US market" but that
> idea
> > was discarded by regulatory affairs.
> >
> > I looking forward to hearing any suggestions offline
> >
> > Med venlig hilsen - Best regards
> > Verner Andersen
> > Technical Writer
> >
> > Radiometer Medical ApS
> > Phone +45 3827 3612
> > Fax +45 3827 2727
> > verner.andersen at radiometer.dk
> > --------------------------------------------------------
> >
> 
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