udi for Legacy devices
We have 1 product group under CE MDD.(Legacy medical device)
This certificate is valid till end 2023.
Must we place new symbols/UDI codes acc. MDR on our labels after 26-05-21?
There are no expected changes to the product.
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ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
No, you do not need to put the UDI number until you will go to the certification under MDR (end of 2023). If you go through Article 120 Transition provisions of the MDR, there you will see which elements from MDR must be prepared for periodic MDD audit after May 2021:post-market surveillance, market surveillance, vigilance, and registration of economic operators.
For more information, see:
- EU MDR Article 120 Transition provisions - https://advisera.com/13485academy/mdr/transitional-provisions/
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Feb 03, 2021