Sam Lazzara
Trusted Information Resource
Here is my theory:
1. Using symbols on medical device labels avoids words.
2. Avoiding words on labels avoids the need to translate those words into the languages required by national regulatory authorities.
3. Avoiding translations reduces clutter and saves valuable label space that can be used for information that matters most to healthcare professionals, thereby improving product usability.
To make this legal, the label symbols must be defined in the Instructions For Use and the IFU must be translated into the required languages. In Europe, symbols that are "harmonised" (published in EN 980) are not required to be translated in the IFU. However, for the sake of worldwide risk reduction I recommend always defining symbol meaning in the IFU. I would not assume that healthcare professionals know what all those harmonised symbols mean.
So do your labels a favor. Use symbols not words, and define them in your multi-language IFU.
1. Using symbols on medical device labels avoids words.
2. Avoiding words on labels avoids the need to translate those words into the languages required by national regulatory authorities.
3. Avoiding translations reduces clutter and saves valuable label space that can be used for information that matters most to healthcare professionals, thereby improving product usability.
To make this legal, the label symbols must be defined in the Instructions For Use and the IFU must be translated into the required languages. In Europe, symbols that are "harmonised" (published in EN 980) are not required to be translated in the IFU. However, for the sake of worldwide risk reduction I recommend always defining symbol meaning in the IFU. I would not assume that healthcare professionals know what all those harmonised symbols mean.
So do your labels a favor. Use symbols not words, and define them in your multi-language IFU.
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