MDR Language Requirements in Belgium

The European Commission has changed the rules for all medical device manufacturers with the Medical Device Regulation MDR, which was introduced to increase patient safety.

Belgium as EU-Member State determines three languages as official: Dutch (Flemish), French, and German. These languages reflect the linguistic diversity within the country. 

Dutch is spoken by the majority of the population, primarily in the northern region of Flanders. French is spoken by a significant portion of the population, especially in the southern region of Wallonia and the Brussels-Capital Region. German is the official language in a small eastern area of Belgium, near the border with Germany.

The linguistic division in Belgium has a significant impact on its political structure, with different language communities having their own regional governments and administrations. The country strives for multilingualism and has language-related policies to accommodate the linguistic diversity of its citizens. 

This linguistic diversity is also represented in the language requirements introduced by the implementation of the Medical Device Regulation 2017/745 into Belgian law. The new Medical Device Act came into force on 26/05/2021 in Belgium and was published by the country’s competent authority the Federal Agency For Medicines And Health Products (FAMHP).

Language Requirements for Labeling and Instructions for Use (IFUs)

Belgian law obliges all manufacturers to provide product information in French, Dutch and German. This means all information which accompanies the device or product and which is to be made available to the patient and includes IFUs and labelling.

“Pursuant to Article 10, paragraph 11, of Regulation 2017/745, manufacturers shall accompany the devices made available to the user or patient on Belgian territory with the information referred to in Annex I, Section 23, of the Regulation 2017/745 in the three national languages.” – Art. 9(1) Medical Device Act

However, Belgian legislation mentions exemptions for the languages accepted in the same article and determines that if the medical device is only meant for a professional user, the information may be provided in English. At the same time Belgian law states:

“In this case, however, the user may require the manufacturer to provide this information in the national language of his choice.” - Art. 9(1) Medical Device Act

We recommend to double check with notified bodies, competent authorities and end users, to avoid any risks.

Language Requirements for the EU Declaration of Conformity

The declaration of conformity (DoC) is a document which is to be submitted by the manufacturer to the competent authority of the target market country. It serves as declaration from the manufacturer, who declares that the product is compliant to all necessary European as well as national legislations.

“Pursuant to article 19, paragraph 1, of regulation 2017/745, the EU declaration of conformity is translated into one of the three national languages or into English.” – Art. 14, Medical Device Act.

This should not be confused with the certificate of conformity (CoC). This is a document which is issued by a Notified Body to a product that meets a minimum set of regulatory, technical and safety requirements. If the Belgian FAMHP is going to take over the conformity assessment (Art.19(1)) as well if it is a foreign Body:

“Pursuant to article 52, paragraph 12, of regulation 2017/745, the notified body must make available all the documents relating to the procedures referred to in article 52, paragraphs 1 to 7, and 9 to 11, of the regulation 2017/745 in one of the three national languages or in English.– Art. 24, Medical Device Act

Language Requirements for the Implant Card

The implant card is a document which must be submitted to all patients who have been implanted with a medical device. In contrast to other countries, Belgian law states that it is the patient himself who can choose one of the three national languages in which he/she wants his/her implant card to be.

“Pursuant to Article 18, paragraph 1, of Regulation 2017/745, the manufacturer of an implantable device provides the implant card and the information referred to in Article 18, paragraph 1, of Regulation 2017/ 745 in one of the three national languages or in English at the choice of the patient or his representative.” – Art. 13(3), Medical Device Act.

So as medical device manufacturer you should take this into consideration and think about having three translated versions prepared for such cases. Whenever you do so, make sure to use a translation a company specialized in medical device translation. You can identify quality translation services easily, just ask the language provider if they are ISO 13485-certified or not. In accordance with the EU regulation, the manufacturer must make sure that the user fully understands the product accompanied by the information like an implant card.

Language Requirements for the Field Safety Notice

According to the Belgian Medical Device Act, the field safety notice must be provided in German, French and Flemish.

“The safety notice referred to in Article 89, paragraph 8 of Regulation 2017/745 is written in the three national languages.” – Art. 65, Medical Device Act.

But this article does have one exception, which is related to the lay person and professional use:

“As an exception, for devices whose users are exclusively healthcare professionals, this information may be provided in English. In this case, however, the user may require the manufacturer to provide this information in the national language of his choice.” - Art. 65, Medical Device Act.

All medical device manufacturers should be aware of these language requirements and be careful when they send out the corrective actions in the context of the analysis of serious incidents. All reports must be made available in “one of the three national languages or in English” as well (Art. 66, Medical Device Act).

Conclusion

In conclusion, the text highlights the language requirements for medical devices in Belgium which all manufacturers, distributors and importers should know. Due to Belgium's linguistic diversity, manufacturers are required to provide product information, including labeling and instructions for use, in French, Dutch, and German. Exceptions are made for devices intended for healthcare professionals, where English may be used, but the user can request information in their preferred national language.

The EU Declaration of Conformity, implant card, and field safety notice must also be provided in the appropriate languages. Compliance with these language requirements is crucial when communicating corrective actions or reporting serious incidents. Manufacturers should consider having translated versions prepared and may benefit from working with a specialized medical device translation company. Those companies use professional translators who have technical knowledge, experience in the medical field and most probably offer translations into all 24 official languages of the European Union.