The condom is considered in a class IIb medical device, it is subject to certain legal requirements.
In Europe the condom must be CE ISO 4074: 2002 standard and must be packaged and / or stored in a warehouse with the ISO 13485 certification.
The condom must always be packed with instructions for use and the aluminum foil must be protected by packaging. The packaging protects the condom and the instructions are on the inside or outside of the packaging.
The indications must be readable and understandable for the user, the language stated in the instructions must be the language of the issuing country.
The content of the expiration date, batch number, the number of the CE and the name and address of the manufacturer and / or importer of condoms must be visible inside the cover. On the foil of the condom, the CE, expiry date and lot number must be shown.
We have relationships with different qualities and legal services for the manufacturers to be able to advise you better.
The languages of the manual
Depending on the country of issue of the condom packaging, the law requires multiple languages to be used for the instructions. For example, in countries such as Belgium or Switzerland where more official languages are common, it is recommended to draw up the operating instructions in two languages. For countries such as Germany or France, one language is sufficient. For a general European export, it is recommended to use German, English, Spanish and French in the manual.
We have our manual in different languages, if the language you want is not present, we can make sure that this will happen.
The space available on our covers for indicating the legal information allows the use of a maximum of 2 languages.