Description

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.

For technical support, please contact us at: help@mastermindtranslations.co.uk

Also available in our IFU + DoC package offer.