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MDD - distributor

#1
Hello,

is it allowed, based on the MDD, that a distributor (based on the agreement with a manufacturer) adds to a medical device an IFU in the local language and an electrical cable which meets the local requirements?
 
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shimonv

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#2
When a distributor does something like that he becomes part of the manufacturing process. I don't see an issue with that except that he must be treated as a "contract manufacturer" and be required to show that he has the necessary QA processes to perform the task. Also, the DHRs will need to be updated after the distributor did his part.

Shimon
 
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