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udi for Legacy devices

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Guest user Created:   Feb 02, 2021 Last commented:   Feb 03, 2021

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.

ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Feb 03, 2021

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:

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