By applying these harmonized symbols you need no further textual explanation on the packaging of your product.
Medical device labeling symbols.
Labeling regulations pertaining to medical devices are found in the following parts of title 21 of the code of federal regulations cfr.
The use of symbols in medical device labeling final rule final rule including the requirement for a glossary only applies to symbols that are used to convey information required by or under.
If your company manufactures medical devices medicines or medical related equipment you will definitely need the en iso 15223 1 medical symbols for labelling your products worldwide.
Iso 15223 1 clause 5 1 1 medical devices symbols to be used with medical device labels labelling and information to be supplied.
Manufacturer indicates the medical device manufacturer.
Iso 15223 1 medical devices symbols to be used with medical device labels labeling and information to be supplied 5 1 1 manufacturer indicates the medical device manufacturer as defined in eu directives 90 385 eec 93 42 eec and 98 79 ec.