Regulatory Open Forum

Dear members,

Please assist with the following inquiry. The EU Commission has recently released new guidance titled "Overview of Language Requirements for Manufacturers of Medical Devices." We would like to know if it is necessary to translate the address of the LM, Importer, and EU REP on the multilingual artwork within the EU. Can the address remain in English?

Thank you for your help.

Good day Larisa,

There are certain information which has been "accepted" as not needing translation, these include the Trade/Brand Name, Company Name, and associated information like addresses.  In fact, translation of company contact information may result in not being able to resolve if street names or cities are not understood from the Postal service perspective.  As an example, Vienna, Austria in the local language is Wien, which if used in other countries say from US or UK might introduce confusion or not arrive successfully.  With that said, if there are local language versions of labelling which are used, it might be beneficial to have in the local language.  This should be reviewed from a user perspective, such if products are for lay-person use, local contact is in the country, than having local postal address or contact information might be helpful or necessary.  I remember time ago when distributing product from the U.S. using the Toll Free number "800" sending products abroad and we wondered why we did not have any customer contacts from other countries.  We found out a short time later, the Toll Free number (being an oversight) did not work in those other countries.

Dear members,

Please assist with the following inquiry. The EU Commission has recently released new guidance titled "Overview of Language Requirements for Manufacturers of Medical Devices." We would like to know if it is necessary to translate the address of the LM, Importer, and EU REP on the multilingual artwork within the EU. Can the address remain in English?

Thank you for your help.