Belgium
Dutch, French and German - any one of the above as required by the
professional user and all three for patient use.
Denmark
Danish - English was allowed for professional-use active implantable
medical devices until June 1998.
Finland
Finnish and Swedish - Information accompanying the device must be in
Finnish, Swedish or English, unless the information takes the form of
generally known directions or warning symbols. Information intended for users
or patients to ensure the safe use of the device must be in Finnish and
Swedish.
Germany
German - other EU languages may be used for non-safety data.
Iceland
Icelandic - other languages (Finnish, Swedish) understandable to
professional user may be used.
Luxembourg
English accepted for professional use - patient information in French, German
and Liezeburgish.
Netherlands
Dutch - English may be negotiated for professional use.
Norway
Norwegian - English accepted for professional use.
Sweden
Swedish - English may be negotiated for professional use.
Switzerland
French, German and Italian - Romanish also acceptable
UK
English on label - other EU languages accepted on insert if language stated on
label.
In Austria, France, Greece, Ireland, Italy, Portugal and Spain
only the national languages may be used.
