MedicalDevice
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Hi,
I read in the MDR the following sentence concerning the UDI:
"(97) In order to provide for a smooth introduction of the UDI system, the moment of application of the obligation to place the UDI carrier on the label of the device should vary from one to five years after the date of application of this Regulation depending upon the class of the device concerned."
Could someone explain this to me? Does it mean that from the moment that the new MDR is put into action (May 2020), there will be a 5year transition period where the companies will be able to implement it (according to their class)?
If yes, does anyone know what the timeline is for implementing the UDI for each class? (I am mostly interested in class IIb).
Thank you in advance!
I read in the MDR the following sentence concerning the UDI:
"(97) In order to provide for a smooth introduction of the UDI system, the moment of application of the obligation to place the UDI carrier on the label of the device should vary from one to five years after the date of application of this Regulation depending upon the class of the device concerned."
Could someone explain this to me? Does it mean that from the moment that the new MDR is put into action (May 2020), there will be a 5year transition period where the companies will be able to implement it (according to their class)?
If yes, does anyone know what the timeline is for implementing the UDI for each class? (I am mostly interested in class IIb).
Thank you in advance!
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