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Symbol MD in the label of Medical Devices Class I (no sterile)

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Isabel Sottomayor Created:   May 26, 2021 Last commented:   Sep 13, 2022

Symbol MD in the label of Medical Devices Class I (no sterile)

Hello,   from today on, to be compliant with the new EU MDR, the production of Medical Devices Class I (non sterille), needs to have the MD symbol in the label?   Thank you, Isabel Sottomayor
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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić May 27, 2021

All class I medical devices according to the MDR, from today, have to be in compliance completely with the MDR Technical requirements (Annex 2 _ Technical documentation). One of those requirements is to have an MD symbol on the label. For details on what needs to be on the label, please see section 23 of Annex 1 – General safety and performance requirements.

For more information, please see:

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Tina May 03, 2022

Is the MD Symbol on the label mandatory for all Classes of Medical Device?  

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Kristina Zvonar Brkić May 03, 2022

Yes it is, it is stated in the Annex I General safety and performance requirements, section 23.2 The label shall bear all of the following particulars: q) an indication that the device is a medical device

For more information, see:

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Guest Sep 12, 2022

Can MD symbol be used on the label of a medical device that is in compliance with MDD? Or it is restricted for devices in compliance with MDR?

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Kristina Zvonar Brkić Sep 13, 2022

It is not forbidden to put it on the MDD compliance device, but it means that you need to implement ISO 15223-1:2021 into your system, so all symbols that are required in that standard and applicable for your device should be implemented. Also, it means that you need to change your essential requirement checklist with this new standard. 

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May 26, 2021

Sep 13, 2022