List of languages accepted for labelling and IFU, and the declaration of conformity in the 27 EU Member States, Iceland, Liechtenstein, Norway, Switzerland, Turkey, Serbia, and Montenegro in line with the language requirement 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 English summaries of national legislation and/or official guidelines, as well as links to the quoted sources
EU MDR & IVDR Language Requirements for Labelling, Instructions for Use, and the Declaration of Conformity
The Medical Devices Regulation (MDR) 2017/745/EU and the In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746/EU allow the 27 EU Member States (and several non-EU countries which have aligned their medical devices legislation with that of the EU) to establish individually at the national level which language(s) they will accept for product information (labelling, IFU, GUI) and the declaration of conformity for medical devices and in vitro diagnostic medical devices (IVDs) placed on their respective national markets.
This bundle contains our two EU MDR & IVDR Language Requirements products:
These two products can be purchased separately or, at a reduced total price, together in this bundle.
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 their first publication, the EU MDR & IVDR Language Requirements (Labelling & IFU) and (Declaration of Conformity) lists have 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:
‘This is great. It is so helpful. Thanks for sharing the details.’
A Kirindigoda Hewage, QARA Lead, Osteon Medical, Australia
‘Many thanks for the uncomplicated handling. This list will help us a lot in the future.’
R Sersi, Master Data Management, HUM Gesellschaft für Homecare und Medizintechnik mbH, Germany
‘Thank you for taking the guesswork out of our market entry strategy. Your language lists for labelling, IFU and the DoC have helped us put together the missing pieces of this puzzle.’
Director of International Sales, US medtech company
‘This is exactly the information we needed to start planning our entry into the EU market.’
Senior Regulatory Officer, Japanese medtech company
Payment for our products can be made through either of the following methods:
- Debit/Credit Card: Choose this option for immediate access. Upon payment, you will receive a confirmation email with the download link. Within 48 hours, you will also receive a VAT invoice for your order.
- Bank Transfer: If you prefer to pay through a VAT invoice, at the checkout please choose a bank transfer to request a VAT invoice, which will include our bank details.
After making the payment, you will receive a confirmation email with the download link. To expedite the process, you can email us a payment confirmation as evidence of your payment.
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.
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.
- 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: email@example.com.
- 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: firstname.lastname@example.org. We are here to assist.