欧盟成员国中标签的语言使用要求.docVIP

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 on