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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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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