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欧盟成员国中标签语言使用要求
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
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