Sample pages of the list of languages accepted for labelling and IFU in the 27 EU Member States, Iceland, Liechtenstein, Norway, Switzerland, Turkey, Serbia, and Montenegro in line with the language requirements set out in the EU Medical Devices Regulation (MDR 2017/745/EU) and the EU In Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746/EU) with summaries of national legislation and links to the official sources
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Free sample of EU MDR & IVDR Language Requirements (Labelling & IFU), consisting of five pages. The full version of this MDR/IVDR Language List for Labelling and IFU is available for purchase as a standalone document or as a bundle together with EU MDR & IVDR Language Requirement (Declaration of Conformity).
The language requirements set out in the Medical Devices Regulation (MDR) 2017/745/EU and in the In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746/EU apply to a range of information intended for the end user of a medical device or an in vitro diagnostic medical device (IVD), respectively.
Both, the MDR and the IVDR, allow individual EU Member States to decide at the national level which official EU language(s) they will accept for product literature (labelling and IFU). There are also several European countries which are not EU Member States but have harmonised their national medical devices legislation with the MDR and the IVDR to have access to the EU single market.
For the purpose of the MDR and the IVDR, 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/IVDR Language List (Labelling & IFU) list provides details of the language(s) accepted for the information accompanying a medical device or an in vitro diagnostic medical device (IVD) intended for layperson use 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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Also available in our IFU + DoC package offer.
For more information on the MDR/IVDR language requirements, please read our recent articles:
- What Are the Language Requirements for Medical Devices Sold in the EU Market under the New EU Medical Devices Regulation?
- Which Languages Are Accepted under the MDR Language Requirements in Each EU Member State? (in English, German or French)
- What Are the EU IVDR Language Requirements and Which Languages Does Each EU Member State Accept?
- What Are the EU MDR/IVDR IFU Translation Requirements for Manufacturers of Medical Devices?
- What Is the EU MDR/IVDR Language Requirement for the Declaration of Conformity for Medical Devices? (in English, German or French)
- What Are the EU IVDR Language Requirements for Screens and Software?
- What Are the MDR and IVDR Language Requirements for Field Safety Notices for Medical Devices?
- FAQs: Language Translation Requirements for Medical Device Companies Operating in the EU under the New EU MDR and IVDR