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
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