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
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ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
According to the provided information, since it goes on the implant and therefore into the body, in my opinion classification Rule 21 is applicable - Devices composed of substances that are introduced via a body orifice or applied to the skin, but for all other cases - class IIb (similar like vaginal gels). For more details please see MDCG 2021-24 Guidance on classification of medical devices.
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Jan 07, 2025