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Hello! Thank you @Erik Vollebregt, @Richard Vincins, @Carolin Bombek, @Uwe Zeller for your replies, your comments are very useful. We had already reviewed the requirements and guidance, however, some holes need to be clarified. It seems that there are still things subject to interpretation. Regards ...

Dear community  Could somebody help me with some advice on the following questions: When two devices have interaction, combined with no physical interconnection, to achieve a specific medical purpose, e.g. the interaction is given by an RFID signal. Should this be considered as a System per EU ...

Dear all We are looking for an expert consultant on packaging and labeling for medical devices. I will appreciate your recommendations Regards ------------------------------ C.Oviedo Sr. RA Specialist linkedin.com/in/carolina-oviedo-5251a4b7 ------------------------------

Hello, Thank you everyone for your answers and recommendations. They have been very useful.  ------------------------------ C.Oviedo Sr. RA Specialist linkedin.com/in/carolina-oviedo-5251a4b7 ------------------------------

Thank you for your answer Mrs. LeBlank. I agree with you that the process has to be robust enough to address related risks to the reuse. That´s why it is included in the risk documentation and also communicated through the IFU.  Having a symbol to communicate this information on the label should be ...