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Hello,
Looking for some information on how other companies are approaching the MDR requirements for their Class Ir devices. In particular:
- Determination of the device lifetime when usage of device may vary from hospital to hospital.
- Direct part marking - how to ensure that the DPM will remain readable when subject to the number of reprocessing cycles expected within the device's determined lifetime. Given that there will be no transition period for these devices and their lifetime may be multiple years, how can this be/ has these been achieved in time?