We have recieved a request from our agent in Russia, that the ministry is asking for an IFU according to a list that they provide us. Our current IFU does not seem to meet the requirements. We are of the opinion, that we do not even need an IFU, because it is a low-risk product that is only used by professionals.
Please comment!
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Florian Tolkmitt
sfm medical devices GmbH
Germany
florian.tolkmitt@sfm.de -------------------------------------------