Guidance for dealing with "old" devices
Assign topic to the user
Your guidance is MDR itself. It means that if you are a class I device, that from 26th May 2021. you need to be in compliance with the MDR, The only excuse for that is the implementation of the UDI number, which must be applied until May 2025, as stated in Article 123 Entry into force and date of application.
For more information, see:
EU MDR Article 123 Entry into force and date of application https://advisera.com/13485academy/mdr/entry-into-force-and-date-of-application/
Comment as guest or Sign in
Dec 13, 2021

