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
envoyLanguage 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
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
Accompanying documentation must be in
新东方 培训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 None
质点系FRANCE French May want to check technical
documentation/clinical trial
information in French
GERMANY German None
GREECE Greek None
HUNGARY MDD+AIMD:Hungarian
教育培训中心IVDD Instructions For U MUST be
in Hungarian
ICELAND Icelandic None
荷兰语翻译中文
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
Malte or English.
NETHERLANDS Dutch MDD:Dutch language waiver possible
upon special application to Dutch
Competent Authorities.
奥斯卡奖电影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
love will rememberROMANIA Romanian MDD Labels may be in English IUF+CE
Certificates must be in Romanian by a
certified translator.
SERBIA(Pending EU State) Serbian
stockingsworldSLOVAKIA Slovak
Some Czech accepted.be sure to
Clarify first.
SLOVENIA Slovenian Labels and IFU must be in
Slovenian. Slovenian IFU for
exhaustedlf-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.fine什么意思中文
