Today the EU Commission released two new documents:

These tables consolidate the language translation requirements for 31 EU countries.

Until now, manufacturers had to review each member state’s website/legislation, to confirm their language requirements. (Note: Casus has an interactive tool that consolidates all this information – link available under ‘Further Reading’.)

We were expecting the above, as it was mentioned in the MDCG Working Group’s October 10-11, 2023 Final Meeting Minutes:

“To provide all stakeholders, especially SME manufacturers, with an overview of language requirements … the Commission informed that a table will be circulated to MDCG members asking to correct and complete the information with regards to their national legislation. This language requirement table is foreseen to be published on the Commission’s website once completed.”

Overview

What information is included?

The EU Commission’s language translation tables outline the requirements for the following documentation, per country:

Which countries are covered?

The EU Commission’s language translation tables cover 31 countries: the 27 EU member states; Iceland, Liechtenstein, Norway and Turkey.

It does not include:

NOTE: Casus’ Language Requirements Tool does include requirements for Northern Ireland and Switzerland.

Further, the MDR/IVDR tables note, via asterisk, if the data included is not recent.

Software Interface Translation Requirements

Whether software interface (e.g., apps) require translation, is a common question raised by manufacturers.

While the MDR/IVDR tables do have a column covering this requirement, it is not populated for all markets. Only 16 of the 31 countries have the software translation requirements listed.

Generally, software interface is considered part of the “information supplied with the device” under MDR/IVDR, Annex I. For the most part, this is reflected in the EU Commission’s language translation table, i.e., the majority of the 16 countries have the same requirements under both the ‘Label/IFU’ and ‘(Graphic) User Interface’ columns. However, there are some exceptions. For example, France states that the interface for professional users can be in:

“French or English, based on general requirement 5 (no art. in the national law) taking into account the skills and the means available to the users and the influence resulting from variation that can be reasonably anticipated in the user’s technique and environment”

Summary of Safety & Clinical Performance (SSCP)/Summary of Safety & Performance (SSP)

There is no separate column covering this topic. Instead, at the end of each document, the following is noted:

MDR Table: “For the Summary of Safety and Clinical Performance of a device (SSCP), Art. 32 MDR, please see the MDCG-2019-9 Rev.1 Guidance Document, that recommends the SSCP to “be written in a way that is clear to the intended user and, if relevant, to the patient (see MDR, Annex II (2), Article 10 (11)), the SSCP should be translated into the languages accepted in the Member States where the device is envisaged to be sold”(p. 6).”

IVDR Table: “For the Summary of Safety and Performance of a device (SSP), Art. 29 IVDR, please see the MDCG-2022-9 Template.”

Further Reading

Additional resources you may be interested in:

*The Language Requirements Tool will be updated to incorporate the additional information provided in the EU Commission’s tables, so that it remains remains a current industry resource.