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

[Corcoran, Susan]

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
> --------------------------------------------------------
>