Hello,
I have a question regarding a possible repackaging of class II & class I medical devices according to the Regulation (EU) 2017/745 and Regulation (EU) 2017/746. Is it possible to combine a number of devices under one single package? The devices considered are non-sterile devices and do not form a system or procedure pack. The combination would be made available to the end user and all the original labels and IFU would be kept according to the manufacturer.
Thank you in advance for your help!
I have a question regarding a possible repackaging of class II & class I medical devices according to the Regulation (EU) 2017/745 and Regulation (EU) 2017/746. Is it possible to combine a number of devices under one single package? The devices considered are non-sterile devices and do not form a system or procedure pack. The combination would be made available to the end user and all the original labels and IFU would be kept according to the manufacturer.
Thank you in advance for your help!
