Hi Anon,
If you use symbols according to harmonized standards (which do not exist yet), there is no requirement for translation.
You can also use other symbols, but you have to explain their meaning.
A common practice from the manufacturers is to repeat in the IFU some translated warnings or other critical information, which are already included in the symbols.
In my opinion, anything critical must be clearly stated on the label, because most of the end users (even professionals) do not read the IFU, or read only the basics.
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Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece
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Original Message:
Sent: 23-Sep-2020 00:15
From: Anonymous Member
Subject: IVDR - Symbols Used in an EU only IFU
This message was posted by a user wishing to remain anonymous
Symbols are used from an EN recognized standard in an IFU for an IVD intended to satisfy IVDR requirements, do they need to be defined and translated for each market in the EU the product is sold? Or is the symbol sufficient since it comes from and EN standard?
The product is only intended to be sold in the EU
Thanks