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LANGUAGES & LABELING
INSTRUCTIONS FOR USE
Labeling documentation requiring translation into a specified language include the:
PACKAGE LABEL & PRODUCT MARKETING
To date, the Medical Device Regulation (MDR 2017-745) recognizes 24
official Union languages, including those of the member states, as
well as non-EU Member State Turkey and European Free Trade
Agreement countries Switzerland and Norway. Device labeling shall
be made available to the user or patient in the MDR accepted
languages denoted in Table 1 on the reverse side.
The European Union Medical Device Regulation (MDR 2017-745)
includes new requirements for labeling and languages. Labeling is a
critical element of a company’s medical device offerings and should
be provided in the language appropriate for end users.
Package or product labels shall include translations of the product
description per Annex I, Section 23.2, Part (b), critical
warnings/precautions per Annex 1, Section 23.2, Part (m) and other
general text that is not the product trade name or defined by a
recognized symbol.
Generally stated, if you are trying to include text in addition to an
alphanumeric code, contact details, trade name, or graphical symbol,
it’s required to translate the text either on the label or package insert
into the officially recognized languages to meet MDR requirements.
The IFU shall have both general text and symbol definitions
translated per Annex 1, Section 23. IFUs constitute a majority of
the necessary translations to Member State languages.
• Instructions for Use • Package Label • Product Marketing
WHAT YOU NEED TO KNOW
MDR LANGUAGES & LABELING
WHAT DOES IT SAY?
Article 10, Section 11 of the new European Union
Medical Device Regulations (EU MDR) requires
manufacturers to translate the IFU, package
label and product marketing for devices.
IT STATES:
Annex II, Section 2 of the new European Union
Medical Device Regulations (EU MDR) states
that manufacturers must supply items
SUCH AS:
Manufacturers shall ensure that the device is
accompanied by the information set out in Section
23 of Annex I in an official Union language(s)
determined by the Member State in which the
device is made available to the user or patient. The
particulars on the label shall be indelible, easily
legible and clearly comprehensible to the
intended user or patient.”
A COMPLETE SET OF:
• The label or labels on the device and on its
packaging, such as single unit packaging, sales
packaging, transport packaging in case of
specific management conditions, in the
languages accepted in the Member States
where the device is envisaged to be sold...
• The instructions for use in the languages
accepted in the Member States where the
device is envisaged to be sold.”
M-010-01
networkpartners.com
574.377.7151
network-packaging-partners
@NetworkPartner5
@NetworkPartner5
LET US HELP YOU PREPARE FOR IMPLEMENTATION OF ARTICLE 10 & ANNEX I I OF THE EU MDR.
Do you have more EU MDR questions?
Contact Network Partners. We can help you navigate the new regulations.
TABLE 1. EU OFFICIALLY RECOGNIZED LANGUAGES
COUNTRYMDR LANGUAGE
ACCEPTEDLANGUAGE COUNTRY CODE
(FOR LABELING)
AustriaGermanyBelgium*Luxembourg*Switzerland*Belgium*Luxembourg*FranceSwitzerland*
German
French
English
Dutch
BulgarianCroatian
CzechDanish
EstonianFinnish
Greek
Hungarian
Italian
LatvianLithuanian
PolishNorwegianPortugueseRomanian
SlovakSlovenianSpanishSwedish
Turkish
DE
FR
EN
NL
BGHRCSDAETFI
EL
HU
IT
LVLTPLNOPTROSKSLESSV
TR
IrelandMaltaUnited Kingdom
EnglandScotlandWalesNorthern Ireland
Belgium*NetherlandsBulgariaCroatiaCzech RepublicDenmarkEstoniaFinlandGreeceRepublic of Cyprus*HungaryItalySwitzerland*LatviaLithuaniaPolandNorwayPortugalRomaniaSlovakiaSloveniaSpainSwedenRepublic of Cyprus*Turkey
* denotes multiple acceptable languages
M-010-01
networkpartners.com
574.377.7151
network-packaging-partners
@NetworkPartner5
@NetworkPartner5
