EU MDR Language Requirements Table 2024 – FREE Sample

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Sample pages of the table of languages accepted for the label/IFU, GUI, implant card, FSN, and DoC in the 27 EU Member States, Iceland, Liechtenstein, Norway, Switzerland, Turkey, Serbia, and Montenegro under the language requirements set out in the EU Medical Device Regulation (MDR 2017/745/EU) with English extracts from national legislation

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Description

Free sample of the EU MDR Language Requirements Table 2024, consisting of five pages.

The language requirements set out in the Medical Device Regulation (MDR) 2017/745/EU apply to a range of information intended for the end user of a medical device.

The EU MDR allows individual EU Member States to decide at the national level which official EU language(s) they will accept for the label/IFU, GUI, implant card, FSN, and DoC. There are also several European countries which are not EU Member States but have harmonised their national medical device legislation with the MDR to have access to the European single market.

For the purpose of the MDR, there are 24 official EU languages. While a couple of EU countries, such as Belgium and Finland, expect the information supplied with a device intended for the layperson to be available in all their national languages, other EU countries, such as Luxembourg or Poland, allow certain exceptions. Furthermore, several countries, such as Austria and Cyprus, waive their national language requirements for devices intended exclusively for professional use.

The full version of this EU MDR Language Requirements Table 2024 provides details of the language(s) accepted for the information accompanying a medical device intended for layperson and professional use in each of the 27 EU Member States plus Iceland, Liechtenstein, Norway, Switzerland, Turkey, Serbia, and Montenegro. In addition, it also includes relevant extracts in English from national legislation and/or official guidelines of each country, as well as clickable links to the official sources.

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For more information on the MDR/IVDR language requirements, please read our recent articles: