Medical device "MD" symbol

TomQA

Involved In Discussions
Hello,
is it required by the MDR to have the "MD" symbol on the label (GSPR 23.2(q)).
medical-device.png
Do you know if this symbol needs to be on the "device label" or is the packaging label sufficient?
Thanks !
 

Jean_B

Trusted Information Resource
You can verify the current harmonized standards at Medical devices.
There you'll find the summary list at the bottom of the page, with the currently harmonized EN ISO 15223-1 standard being edition 2021.
For the EU MDR, that edition includes a table in annex ZA, which will tell you (if present) what GSPR is (partially) covered by what symbol.
23.2 (q) refers to symbol 5.7.7. That is the symbol you are showing. Using that symbol gives (partial) presumption of compliance to GSPR 23.2 (q).
The table also notes it does not cover labelling of devices intended for clinical use only.
This matches the EU MDR text requirement of "(q) an indication that the device is a medical device. If the device is intended for clinical investigation only, the words ‘exclusively for clinical investigation’;"

You are not obligated to use the symbol, but not doing so incurs all kind of translation etc. obligations so it is best to do so.
The indication needs to appear on the label per EU MDR GSPR 23.2, and the label is expected to be on the device (if practicable and appropriate) per EU MDR GSPR 23.1 (b).
If you can argue that it is not practicable or appropriate, you may move parts of it to the packaging of a medical device/pack of identical medical devices.
I would expect a justification in the form of a risk assessment to differentiate between what must be on device, and what may be moved to a label on the packaging. Start with the presumption it must be on the device in this assessment.
Whether the MD symbol ranks highly or not in that depends mostly on the possibility and (risk) consequences of a mix-up with a non-medical variant after it has left its packaging.

ps. if you look for the harmonization requests you can 'foresee' other standards that will be harmonized somewhere in the future, and get a step ahead by incorporating those into your evidence already.
 

TomQA

Involved In Discussions
Wow Thank you so much for your highly detailed and clear answer.
I have everything I need.
Thanks again !
 
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