€399
Table with languages accepted for the label/IFU, GUI, implant card, FSN, and DoC in 34 European countries under the language requirements in the EU Medical Device Regulation (MDR 2017/745/EU) with English extracts from national legislation and guidelines
Single one-off payment
Description
This EU MDR Language Requirements Table 2024 includes:
- Languages accepted for the label, instructions for use (IFU), graphical user interface (GUI), implant card, field safety notice (FSN), and declaration of conformity (DoC)
- 34 European countries: 27 EU Member States plus Iceland, Liechtenstein, Norway, Switzerland, Turkey, Serbia, and Montenegro
- Extracts from national legislation and official guidelines translated by our expert linguists from various European languages into English
- Clickable links to the official national sources
The Medical Devices Regulation (MDR) 2017/745/EU provides 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 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.
Although in January 2024, the European Commission released two language requirements tables for manufacturers of medical devices, they mostly list languages for each country without providing further details on various additional conditions which are contained in the national legislation or guidelines of each country.
With our EU MDR Language Requirements Table 2024 you can benefit from:
- Extracts from national legislation and guidelines, where available, from 34 European countries, translated by our expert linguists into English
- Regular updates as European countries continue to adapt their national legislation and guidelines in response to constantly changing European legal framework for medical devices
- Reliable information based on our own experience of translating IFUs, GUIs, FSNs and DoCs for UK, European, US, and Asian manufacturers who have successfully placed their medical devices on the European market.
Free Sample
Download a free sample of our EU MDR Language Requirements Table to see what information it contains. No personal details or email needed.
Reviеws
Since its first publication in October 2021, the EU MDR Language Requirements Table 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 Language Requirements Table 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 Language Requirements Table 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 Language Requirements Table. 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
Payment
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VAT Information:
Please note that the prices displayed do not include UK VAT. Orders from the UK will have a 20% VAT charge added. However, orders from the EU and the rest of the world are subject to a 0% VAT charge.
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You have the flexibility to pay in three different currencies: € (EUR), $ (USD), or £ (GBP). At the checkout, simply double-click on your preferred currency on the right.
FAQs
- Does this product contain up-to-date information?
Yes. To ensure that you feel confident using our resources, we have made it a priority to regularly update them. We aim to revise our products every six months to incorporate any recent legislative changes in European countries. - Will we receive an update copy of this product?
Yes. When an updated version of the product becomes available, you will receive a complimentary copy via email. You can request an updated copy of the product you have purchased at any time by emailing us at: help@mastermindtranslations.co.uk. - Are there any subscription fees for this product?
No. You only need to make a one-time payment. Your organisation can use the product without any recurring charges. - Are there any usage restrictions?
Your organisation is permitted to use this product for internal purposes. However, if you are a consultancy working with other organisations, your clients should purchase their individual copies. Please note that this product is copyrighted and must not be distributed outside of your organisation or shared publicly. - What is the file format?
Upon purchase, you will receive a download link for the product in the PDF format. The product can be opened with any PDF application and does not require activation or a password. - Who can we contact for technical support?
For technical support, please contact us at: help@mastermindtranslations.co.uk. We are here to assist.
