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MDR Device Labelling

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Chris P Created:   Nov 10, 2022 Last commented:   Nov 11, 2022

MDR Device Labelling

Hello I have a query.  A European manufacturer I use is transitioning to MDR.  They have now included RX only on the label.  This is to satisfy the FDA requirements.  But it is not a UK or EU requirement.  Should this be displayed on the label we sell in the UK and EU? I think it will cause issues. But I am unsure. thanks
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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 Nov 11, 2022

This symbol is not required to be on the labels according to the MDR 2017/745 and harmonized standard ISO 15223-1:2021 Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements. But it is not forbidden. So, you just need to explain in your technical file what is the meaning of this symbol. 

For more information check https://www.iso.org/standard/77326.html

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Nov 10, 2022

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