EU MDR & IVDR Language Requirements (Declaration of Conformity)

13 Oct 2022
by Katarzyna E Slobodzian-Taylor / 0 COMMENTS.

€99.00

List of languages accepted for the declaration of conformity 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 English summaries of national legislation and/or official guidelines, as well as links to the quoted sources

 

Single one-off payment

Also available in our IFU + DoC package offer.

Description

EU MDR/IVDR Language List (Declaration of Conformity) for the 27 EU Member States plus Iceland, Liechtenstein, Norway, Switzerland, Turkey, Serbia, and Montenegro with, where applicable, extracts from national legislations and/or official guidelines in English, as well as 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 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 which language(s) they will accept for the declaration of conformity for medical devices and in vitro diagnostic medical devices (IVDs) placed on their respective national markets.

Although a majority of EU Member States accept a national language version of the declaration of conformity or an English version, a number of EU Member States have stricter rules. For example, some EU Member States, such as Denmark, expect the declaration of conformity to be made available in their national language(s) at the request of the national competent authority. A small number of EU Member States, such as Latvia, require a translation in their national language to accompany the original document. In addition, a couple of EU Member States, i.e. Luxembourg and Poland, extrapolate the MDR/IVDR language requirements for labelling and IFU to the declaration of conformity, and accept different languages, depending on whether the device is intended for layperson or professional use.

In this EU MDR/IVDR Language List (Declaration of Conformity), you will find reliable information on the language(s) accepted for the declaration of conformity in each of the 27 EU Member States as well as in Iceland, Liechtenstein, Norway, Switzerland, Turkey, Serbia, and Montenegro. In addition, the List contains extracts from national legislation and/or official guidelines, where applicable, detailing various exceptions and conditions, as well as clickable links to the official sources.

Also available in a bundle together with the MDR/IVDR Language Requirements (Labelling and IFU) list.

Reviеws

Since its first publication in October 2022, the EU MDR/IVDR Language List (Declaration of Conformity) has been purchased by a number of medtech companies operating on the European market, as well as various consultancy firms supporting their clients on their export journey.

This is what they say:

‘We had no idea how much we could save on translation services by selecting only those languages for the EU Declaration of Conformity that were actually needed. Excellent investment. This list has already paid for itself multiple times.’

Product Manager, Italian medtech company

‘This list is very well researched, and will be an extremely useful reference guide for our clients.’

QA/RA Consultant, UK medical device regulatory consultancy firm

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    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.

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