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Classification of medical device according to MDR
Hello
Kindly ask for your advice in appropriate classification of medical device which is gel called to provide temporary protection to the surface of a typical surgical implant from the attachment of pathogens to the implant surface and the formation of a biofilm. Implant need to be coated with this gel before implantation. It has no drugs, no nanomaterials, manufactured without manufactured utilising tissues or cells of human or animal origin.
Thank you for your thought in advance