We are a U.S.-based, medium-size medical device company with a line of IVD products. We sell our products internationally. Regulations mandate and distributors request that we make our user manuals available in a variety of languages. We understand translating our user manuals into Spanish, French and German (from English) but now we are expected to translate our manuals into Greek, Swedish, Hungarian and Portuguese to name a few. Are you sharing these costs with economic operators or are you covering these costs yourself? We appreciate your responses.
Deborah Van Noy
Regulatory Affairs Associate
370 West 1700 South
Logan, Utah 84321
Tel: 435-752-6011 x1417
We cover these as a cost of doing business. You cannot, under MDR, take the cheap way out as there are requirements for the translation company. They have to be an approved vendor, and we insure they are certified to ISO 17100.
D. Michelle Williams, CESCO
VP – Operations
Action Products, Inc.
t is very important to understand that the liability related to the user's manual rests solely with the manufacturer.It may be possible to share the costs, but the content of the manual should be fully controlled by the manufacturer.Therefore, the agreement should include the cost of updates or the like.Once our EU representative told us that a manufacturer went bankrupt because of an incident caused by an error in the user manual.The error was caused by their distributor who translated the manual.
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