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Luisa Mella
Strumenti medicali
February 2016
Use of IVD symbol on labeling in USA
< 1 min reading time

Goodmorning all, I have a question about the use of the IVD symbol on in vitro diagnostic products in USA. The IVD symbol as defined in ISO 15223 standard should be used to indicate “a medical device that is intended to be used as an in vitro diagnostic medical device”. Then the restriction says: “This symbol should only be used to identify in vitro diagnostic medical devices and not to specify that the medical device is for in vitro use”. So my interpretation of this restriction is that for US market I cannot use this symbol to indicate that a devece is for in vitro use, unless it is also an IVD according to 98/79 EU directive. I should state on labeling “for in vitro use”, without the symbol.
Can anyone working in USA market tell me something more/different about the use of this symbol?
thanks,
Luisa

source: https://www.linkedin.com/groups/2070960/2070960-6103199606147989508

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Posted by Luisa Mella
Asked on February 10, 2016 8:00 am
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Private answer
Hi Luisa, your device is to be used In vitro but does not qualify as an In Vitro Diagnostic device. A true IVD is as follows “IVDs include products used to collect specimens, or to prepare or examine specimens (e.g., blood, serum, urine, spinal fluid, tissue samples) after they are removed from the human body.”
You are correct moving forward and stating“for in vitro use” in the labeling.
I hope this helps!!!
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