Newsletter No 44 April 2024

Subject: Language requirements for manufacturers of medical devices in the context of MDR

In the diverse landscape of the European Union, where multiple languages coexist, ensuring that relevant information about the safe use of the medical devices reaches all types of users is no small feat.

In this newsletter we take an overview on how Regulation 745/2017 on medical devices (MDR) sets language requirements for the various types of medical devices

Which are the language requirements in the EU?

Device manufacturers are required by Regulation 745/2017 on medical devices (MDR) to ensure that the device is accompanied by the relevant information. The information required is set out in Annex I MDR, GSPR section 23. Languages required are the official languages determined by the Member State in which the device is made available to the user or patient. The particulars on the label shall be indelible, easily legible and clearly comprehensible.

The information provided with the device can be on the product, on the various packaging levels or on the instructions for use (IFU). The IFU can be of paper format or provided on the manufacturer website.

Which are the official languages in the European Union?

The EU has 24 official languages: Bulgarian, Croatian, Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Hungarian, Irish, Italian, Latvian, Lithuanian, Maltese, Polish, Portuguese, Romanian, Slovak, Slovenian, Spanish and Swedish.

Are all languages required for all countries where the product is marketed?

Language requirements depend on the member state and on the type of user, with some countries accepting other languages broadly known such as English. Thus, non-professional users typically require more detailed information in the official language/s of the country where the device is marketed.

In this regard, the European Commission has recently issued tables of language requirements to help manufacturers understand the specific requirements for each country. These tables provide information beyond the label, IFU and, when applicable, implant card, covering as well the languages of the declaration of conformity, field safety notice, documents for conformity assessment, and graphic user interfaces (e.g. apps).

Which is the role of the symbols?

The harmonized symbols according to international standard ISO EN 13485:2021 play an important role in communicating relevant information on the labeling without need for translation to the various languages on the label. The symbols are deemed understandable for the users, although some Notified Bodies advise in the direction of adding the descriptions for devices aimed for lay users in the IFUs.

Symbols that are not harmonized can also be used but require descriptions in all required languages in the instructions for use.

How do manufacturers and distributors manage the countries where the device is marketed?

Manufacturers and distributors are required to sign Quality Agreements according to MDR. These agreements include sections for the territories where the products can be marketed, with additional wording extending this requirement downstream to the distribution chain. Agreements may include additional clauses for distributors to add labels for additional languages, with further QMS controls.

Manufacturers arrange languages on the packaging according to the territories agreed in the Quality Agreements, while distributors manage distribution accordingly and notify this requirement to their sub-distributors.

Fluent and transparent communication between manufacturers and distributors guarantees correct language coverage in each territory for safe use of the products by patients and users.

This newsletter is part of our campaign to increase the sensitivity and the awareness of all our business partners, to bring more clarity around the MDR journey and challenges and opportunities around the MDR Art.22 “Systems and Procedure Packs”. 

We are already today all dependent on efficient cooperation. For the MDR implementation, we require even closer collaboration to ensure we all can deliver safe supplies to hospitals and patients in the future.

We are confident we will continue to supply health care competently on customized surgical procedure sets and small kits.

Do you wish to know more about specific MDR topics? Do you have any questions or comments about STS newsletter? Write us at MDR2020@stsmedicalgroup.com.

The next MDR newsletter will be issued in May.

Augusto Orsini
CEO STS Medical Group

Meritxell Laguna
Group Manager Regulatory Affairs
STS Medical Group