T
theola
We are planning to sell a medical device in the EU and the USA.
Is there a possibility to design labels in a way that they are compliant to FDA and EU regulations.
In detail:
Our medical device contains chemicals that require warning symbols on the label. This can/must be used within the EU. As far as I know for the US market only signal words are allowed (e.g. toxic) and no warning symbols. As our labels small we are not able to place both versions on it.
Does someone know a guidance or standard which refers to this topic or has any advice.
Thanks
Is there a possibility to design labels in a way that they are compliant to FDA and EU regulations.
In detail:
Our medical device contains chemicals that require warning symbols on the label. This can/must be used within the EU. As far as I know for the US market only signal words are allowed (e.g. toxic) and no warning symbols. As our labels small we are not able to place both versions on it.
Does someone know a guidance or standard which refers to this topic or has any advice.
Thanks