€449.00
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
Description
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:
1. EU MDR & IVDR Language Requirements (Labelling & IFU) 2023
List of languages accepted for labelling and IFU in the 27 EU Member States plus Iceland, Liechtenstein, Norway, Switzerland, Turkey, Serbia, and Montenegro
2. EU MDR & IVDR Language Requirement (Declaration of Conformity) 2023
List of languages accepted for the EU declaration of conformity in the 27 EU Member States plus Iceland, Liechtenstein, Norway, Switzerland, Turkey, Serbia, and Montenegro
These two products can be purchased separately or, at a reduced total price, together in this bundle.
Free Sample
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.
Reviеws
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
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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.
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No. You only need to make a one-time payment. Your organisation can use the product without any recurring charges.
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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.
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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.
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For technical support, please contact us at: help@mastermindtranslations.co.uk. We are here to assist.
