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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EU MDR/IVDR Language List (Labelling & IFU) for the 27 EU Member States plus Iceland, Liechtenstein, Norway, Switzerland, Turkey, Serbia, and Montenegro with extracts from national legislations in English and clickable links to the official sources
The Medical Devices Regulation (MDR) 2017/745/EU and the In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746/EU provide discretion to the 27 EU Member States to establish individually at the national level which EU language(s) they will accept for the information accompanying a medical device or an in vitro diagnostic medical device (IVD) placed on their respective national markets. There are also several non-EU countries which have aligned their national medical devices legislation with that of the EU to maintain access to the EU single market.
Most EU Member States, such as Hungary, Italy, and Romania, have one official national language. However, there are several EU Member States, such as Luxembourg, Finland, and Belgium, in which two or even three languages share the equal status of an official national language. In addition, while in some EU Member States, such as France or Spain, product literature must be available in the official national language regardless of who the device is intended for, in other EU Member States, such as Poland or the Netherlands, exceptions are allowed under certain conditions for devices intended for professional use.
In this EU MDR/IVDR Language List (Labelling & IFU), you will find reliable information on the language(s) accepted in 34 European countries for the information accompanying a medical device. In addition, the List contains English summaries of national legislation detailing various exceptions and conditions as well as clickable links to the official sources.
Download a free sample of our EU MDR/IVDR Language List (Labelling and IFU) to see what information it contains. No personal details or email needed.
Since its first publication in October 2021, the EU MDR/IVDR Language List has been purchased by a number of medtech companies planning to place their products on the European market, as well as various consultancy firms supporting their clients on their export journey.
This is what they say:
‘Thank you very much. I think it is a helpful tool to comply with the MDR.’
Jürgen Charrier, Quality Manager, Novotec Medical GmbH / Stratec Medizintechnik GmbH
‘This EU MDR/IVDR Language List is an excellent investment for any medtech company looking into placing their device on the EU market.’
Senior RA Officer, Danish medtech company
‘Being able to access summaries of national legislation in English helped us decide which languages we should focus on for each national market. This has not only saved us money on unnecessary translations, but also sped up the whole exporting process’.
Director of Sales, German medtech company
‘Your EU MDR/IVDR Language List is a very useful resource for us. It’d have probably taken us weeks to collect all the information included in it.’
Regulatory Affairs Manager, US medtech company
‘I am so very grateful for your commitment! I completely understand collecting this information has been a painstaking process — I have been trying to gain this knowledge myself for a very long time. Your effort in creating this resource is so much appreciated!’
C Levin, Product Manager & Project Leader, CARDIOLEX Group, Sweden
‘Thank you for this EU MDR/IVDR Language List. It has proven to be a very time and cost-efficient way of accessing the key information we needed to proceed with our export plan.’
International Sales Manager, German medtech company
‘Thank you for this incredibly helpful resource. It has saved our Regulatory Department a lot of work.’
Head of Regulatory Affairs Department, US medtech company
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