EU Countries in Blue EFTA Countries in Red | Instructions For U (IFU)+Label Language Requirements | National requirements in Addition to directives | |
AUSTRIA | German | None | |
BELGIUM | Dutch+German+French (All three must be ud for Patient instructions) | None | |
BULGARIA | English Bulgarian for lf-test devices Only. | None | |
CROATIA(Pending EN State) 消防员工资 | Croatian | Old regulations | |
CYPRUS | Non-professional u devices In Greek.Professional U 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 the Exceptions in pending | |
CZECH REPUBLIC | Czech | None | |
新生儿粟粒疹图片DENMARK | Danish | None | |
ESTONIA | Estonian | IVDD Regulation 54/1999 for Professional urs:Labels and Accompanying documentation must be in Estonian.IVDD Regulation 41/2000 for Manufacturers and suppliers:Only Information necessary for safe u of the device must be provided in Estonian. | |
MDD:Estonian Only | |||
FINLAND | Finnish+Swedish | 父与子的漫画None | |
FRANCE 危字开头的成语 | 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 U MUST be in Hungarian | ||
ICELAND | Icelandic | None | |
IRELAND | English | None | |
ITALY | Italian | 春望教案None | |
LATVIA | Latvian-For professional u English or German is accepted(MDD and IVDD) | ||
LIECHTENSTEIN | German | None | |
LITHUANIA | Lithuanian All product labels+instructions For U | None | |
LUXEMBOURG | French | None | |
MACEDONIA (pending EU State) | |||
MALTA | Malte or English | IVDD:Label+IUF can be provided in Malte 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 ud by professionals only and upon ur’s written connt,IFU can provided in language other than Polish. | |
PORTUGAL | Portugue | 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 | ||
| 折钱包的简单方法 SLOVAKIA SLOVENIA | 损失工作日Slovak Some Czech accepted.be sure to Clarify first. Slovenian | Labels and IFU must be in Slovenian. Slovenian IFU for lf-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. | |
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