We are in process of getting our CE Mark and went through a MDD gap audit and received a non-conformity for our label.
Since a physical label cannot be provided for this software, we need to provide all these required elements along with their corresponding and appropriate symbols:
• Manufacturer's name and address;
• EC-Rep name and address;
• Software version number;
• CE mark.
Also since we note there are a number of precautions and warnings mentioned in the IFU, it would be preferable to also add the IFU symbol and the caution symbol.
And it was noted that all symbols shall be taken from EN ISO 15223-1:2016.
If I purchase EN ISO 15223-1:2016, does this include all the graphic symbols that I can add to our software someplace?
Since a physical label cannot be provided for this software, we need to provide all these required elements along with their corresponding and appropriate symbols:
• Manufacturer's name and address;
• EC-Rep name and address;
• Software version number;
• CE mark.
Also since we note there are a number of precautions and warnings mentioned in the IFU, it would be preferable to also add the IFU symbol and the caution symbol.
And it was noted that all symbols shall be taken from EN ISO 15223-1:2016.
If I purchase EN ISO 15223-1:2016, does this include all the graphic symbols that I can add to our software someplace?