Regulation Note

This page is periodically updated and contains useful information on regulatory requirements related to localization.
For example, what EU National laws state relating to the Medical Devices Directive 93/42/EEC.

COUNTRY LABEL AND DISPLAY SAFETY INSTRUCTION INSTRUCTIONS FOR USE
Austria German German German; exception for professional use possible
Belgium French, Dutch or German; exemptions possible for professional use under certain conditions French, Dutch or German; exemptions possible for professional use under certain conditions French, Dutch or German; exemptions possible for professional use under certain conditions
Bulgaria* Bulgarian    
Cyprus Greek for public use; for professional use English is accepted; English also for software used by health professionals Greek for public use; for professional use English is accepted; English also for software used by health professionals Greek for public use; for professional use English is accepted; English also for software used by health professionals
Czech Republic* Czech Czech Czech
Denmark Danish Danish Danish
Estonia For Label: Estonian; for professional users it can be in English For Display: it can be in English or in some other languages if it is understandable for potential user Minimum information shall be in Estonian For lay user in Estonian and for professional user it can be in English
Finland Finnish, Swedish or English for professional use; Finnish and Swedish for public use Finnish and Swedish Finnish, Swedish or English for professional use; Finnish and Swedish for public use
France French French French
Germany German; in justified cases another language easily understood by the user or other means can be used German or the language of the user German; in justified cases another language easily understood by the user or other means can be used
Greece* Greek Greek Greek
Hungary* Instructions for use for MDD and IVD products as well as reagent and other kit package inserts must be in Hungarian. For professional use only, MDD and IVD software is accepted in English or German according to the wish of the user. If software is not in Hungarian, the screen texts must be in Hungarian in the instructions for use. Software for the lay person must be in Hungarian. On labels international symbols can be used, as well as text in English (e.g. sterile) if the text is not an instruction or warning for safety. Instructions for use for MDD and IVD products as well as reagent and other kit package inserts must be in Hungarian. For professional use only, MDD and IVD software is accepted in English or German according to the wish of the user. If software is not in Hungarian, the screen texts must be in Hungarian in the instructions for use. Software for the lay person must be in Hungarian. On labels international symbols can be used, as well as text in English (e.g. sterile) if the text is not an instruction or warning for safety. Instructions for use for MDD and IVD products as well as reagent and other kit package inserts must be in Hungarian. For professional use only, MDD and IVD software is accepted in English or German according to the wish of the user. If software is not in Hungarian, the screen texts must be in Hungarian in the instructions for use. Software for the lay person must be in Hungarian. On labels international symbols can be used, as well as text in English (e.g. sterile) if the text is not an instruction or warning for safety.
Iceland Icelandic; for the professional user other languages (e.g. Swedish, Danish, Norwegian, German, English) are accepted Icelandic; for the professional user other languages (e.g. Swedish, Danish, Norwegian, German, English) are accepted Icelandic; for the professional user other languages (e.g. Swedish, Danish, Norwegian, German, English) are accepted
Ireland English English English
Italy Italian Italian Italian
Latvia Latvian Latvian Latvian
Liechtenstein German German German
Lithuania Lithuanian Lithuanian Lithuanian
Luxembourg French or German; English for professional users accepted French or German; English for professional users accepted French or German; English for professional users accepted
Malta Maltese and/or English Maltese and/or English Maltese and/or English
Netherlands (exemption for max. 5 years may be granted) Dutch Dutch Dutch; but exception for professional use, but permission from Competent Authority
Norway Norwegian Norwegian Norwegian
Poland Polish; for the professional user other languages are accepted after user acceptance Polish; for the professional user other languages are accepted after user acceptance Polish; for the professional user other languages are accepted after user acceptance
Portugal Portuguese Portuguese Portuguese
Romania* Romanian    
Slovakia Slovak Slovak Slovak
Slovenia* Slovenian Slovenian Slovenian
Spain Spanish Spanish Spanish
Sweden Swedish Swedish Swedish
Switzerland French, German and Italian French, German and Italian French, German and Italian
United Kingdom English English English
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