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 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) Croatian Old regulations喜爱的反义词
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
DENMARK Danish None
ESTONIA Estonian IVDD Regulation 54/1999 for
Professional urs:Labels and
来信未拆打一成语Accompanying documentation must be in
Estonian.IVDD Regulation 41/2000 for
Manufacturers and suppliers:Only百度关键词排名
Information necessary for safe u of
the device must be provided in女性雄性激素过高表现
Estonian.
MDD:Estonian Only
FINLAND Finnish+Swedish None
FRANCE French May want to check technical打工人语录
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 None
LATVIA Latvian-For professional u
English or German is accepted(MDD
and IVDD)
LIECHTENSTEIN German None
None
LITHUANIA Lithuanian
All product labels+instructions
For U
LUXEMBOURG French None
MACEDONIA (pending EU
State)
MALTA Malte or English IVDD:Label+IUF can be provided in七年级上学期班主任工作总结
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
SLOVAKIA Slovak
Some Czech accepted.be sure to
Clarify first.
SLOVENIA Slovenian Labels and IFU must be in
Slovenian. Slovenian IFU for
lf-testing IVD devices is mandatory
举类迩而见义远
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.男性备孕
