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

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

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

Radiometer Medical ApS 
Akandevej 21 
2700 Bronshoj 
Phone: +45 38 27 38 27 
CVR: 27 50 91 85 


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