欧盟成员国中标签的语言使用要求

wf Language Requirement for Labeling in the EU Member states 欧盟成员国中标签的语言使用要求 EU Countries in Blue EFTA Countries in Red Instructions For Use (IFU)+Label Language Requirements National requirements in Addition to directives AUSTRIA German None BELGIUM Dutch+German+French (All three must be used for Patient instructions) None BULGARIA English Bulgarian for self-test devices Only. None CROATIA(Pending EN State) Croatian Old regulations CYPRUS Non-professional use devices In Greek.Professional Use Devices in Greek or English Packaging must show:Sterile devices LOT Custom made devices-MDD Custom made devices-AIMD Devices intended for performance Evaluation IN GREEK CHARACTERS Amendment to accept English for these Exceptions in pending CZECH REPUBLIC Czech None DENMARK Danish None ESTONIA Estonian IVDD Regulation 54/1999 for Professional users:Labels and Accompanying documentation must be in Estonian.IVDD Regulation 41/2000 for Manufacturers and suppliers:Only Information necessary for safe use of the device must be provided in Estonian. MDD:Estonian Only FINLAND Finnish+Swedish None FRANCE French May want to check technical documentation/clinical trial information in French GERMANY German None GREECE Greek None HUNGARY MDD+AIMD:Hungarian IVDD Instructions For Use MUST be in Hungarian ICELAND Icelandic None IRELAND English None ITALY Italian None LATVIA Latvian-For professional use English or German is accepted(MDD and IVDD) LIECHTENSTEIN German None LITHUANIA Lithuanian All product labels+instructions For Use None LUXEMBOURG French None MACEDONIA (pending EU State) MALTA Maltese or English IVDD:Label+IUF can be provided in Maltese or English. NETHERLANDS Dutch MDD:Dutch language waiver possible upon special application to Dutch Competent Authorities. IVDD:English language possible if accompanied by continuous verification process by manufacturer. NORWAY Norwegian None POLAND Polish IVDD+MDD:For devices used by professionals only and upon user’s written consent,IFU can provided in language other than Polish. PORTUGAL Portuguese None ROMANIA Romanian MDD Labels may be in English IUF+CE Certificates must be in Romanian by a certified translator. SERBIA(Pending EU State) Serbian SLOVAKIA SLOVENIA Slovak Some Czech accepted.be sure to Clarify first. Slovenian Labels and IFU must be in Slovenian. Slovenian IFU for self-testing IVD devices is mandatory Professional medical staff devices IFU may be in Slovenian or English. SPAIN Spanish Requires submittance of labeling test to Competent Authorities. Accident report may be filed English. SWEDEN Swedish None SWITZERLAND French,German,Italian None TURKEY(Pending EU State) Turkish Has adopted all EU Medical Directives. UNITED KINGDOM English Manufacturers name on label must be more prominent than any other name.