MDR Language Requirements in Switzerland
Índice de contenidos
Index of contents
Index du contenu
- Language Requirements for Labeling and Instructions for Use (IFUs)
- Language Requirements for the Certificate of Conformity and Declaration of Conformity
- Language Requirements for the Implant Card
- Language Requirements for the Field Safety Notice
- Responsibility for Compliance with Language Requirements
Switzerland is officially multilingual, recognizing four national languages: German, French, Italian, and Romansh. German is the most widely spoken language, with Swiss German, a distinct dialect, prevailing over standard German. Swiss French is predominantly spoken in the western region, while Italian finds its place in the south, particularly in Ticino. Romansh, a descendant of Latin, is spoken by a small percentage in the southeast. Despite being less spoken, Romansh holds cultural significance.
We’ve already seen in our other blog that when it comes to Medical Device Regulation (MDR) language requirements in countries with several official languages like Belgium, it can get a bit confusing for medical device manufacturers to determine which language to use for which information provided with the product. Today we will take a closer look at the probably most famous multilingual country on EU grounds: Switzerland.
Since 2001 the Medical Device Ordinance (MedDO) has been in force to regulate medical devices, but since the EU introduced the Medical Device Regulation 2017/745 Switzerland has modified its legal framework for medical devices to maintain the existing equivalence between Swiss and EU medical device legislation. Switzerland is not an EU-Member, however the Federal Office for Public Health states:
"In recent years, the EU has made requirements for medical devices stricter to increase the quality and safety of these products. The EU Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) entered into force on 26 May 2017.
Switzerland has likewise adapted its legislation to align with that of the EU."
Swissmedic is the national authority for medicines and medical devices in Switzerland. It is responsible for the authorization, monitoring, and control of medical products in the country. There are still some differences when it comes to market surveillance from which Switzerland has been excluded. Nevertheless, when it comes to language requirements, both MDR and Swiss law are in accordance.
On 26th May 2022, the Swiss Federal Council updated and published the Medical Devices Ordinance, which remains fully applicable to this day.
The MedDO is divided into several sections and articles. Relevant information on language requirements for labeling and instructions for use can be found under section 2, Article 16: “Product information” which refer to the information provided by the manufacturer for users or patients.
“It must be written in all three official languages of Switzerland. Symbols established by means of technical standards may be used to replace written statements.” – Art. 16(2), Medical Devices Ordnance
At the same time Swiss law specifies “product information may be provided in fewer than the three official languages of Switzerland or in English” and reduce the need for translation if:
“a.) the device is supplied exclusively to healthcare professionals or is a custom-made device or concerns a medical device in accordance with Article 9;
b.) the user meets the necessary professional and linguistic requirements and qualifications, and is in agreement;
c.) the protection of patients, users and third parties is ensured; and
d.) the efficacy and performance of the medical device are not placed at risk.” – Art. 16(3), Medical Devices Ordinance
The matter of who, when, and what should be translated in specific situations can be open to interpretation. However, to summarize, there are exceptions where information can be in English or just one official language, provided that it is ensured that no harm will come to anyone and that the professional user fully understands all product information without any ambiguity.
If this is not the case, the user “can request additional information in one of the official languages of Switzerland”.
A Certificate of Conformity (CoC) is issued by a third-party certification body, confirming that a product meets specific regulatory standards. It provides external validation through rigorous testing and inspection processes. In contrast, a Declaration of Conformity (DoC) supplied by the manufacturer or authorized representative, asserting the product's compliance with regulations. Both documents play vital roles in demonstrating adherence to regulations, with the CoC offering external validation and the DoC reflecting the manufacturer's commitment.
For both there are also separately regulated language requirements. For the CoC as follows:
“The certificates must be issued in one of the three official languages of Switzerland or in English.” – Art. 25(2) Medical Devices Ordinance
And for the DoC:
“2 The declaration of conformity shall include the information required in Annex IV to EU-MDR, taking account of the amendments to this Annex adopted by the European Commission by means of delegated acts69. It must be written in one of the three official languages of Switzerland or English or translated into one of these languages.” – Art.29(2) Medical Devices Ordinance
This means that if you notified body’s working languages are not one of the official languages in Switzerland, you will need to translate it. Sam goes for the DoC, unless the manufacturer has issued it in English.
According to the MDR-regulation, implant cards are required for implantable medical devices that are intended to be used for a long-term duration and that carry a significant risk if their functionality is compromised or if they are not appropriately used. The information which needs to be set out on the implant card is listed under Article 18 of the MDR.
In line with this, Swiss law states
“The implant card must drawn up in all three official languages of Switzerland.” – Art. 20, Medical Devices Ordnance
Unlike general product information, where manufacturers may have the option to choose the language they prefer, the implant card leaves no room for choice. It is mandatory for the implant card to include information in all three languages.
Regarding the FSN, the Medical Devices Ordinance (Art. 90(g)) simply states to adhere to the EU-MDR Article 89(8) of. Therefore:
“The field safety notice shall be edited in an official Union language or languages determined by the Member State in which the field safety corrective action is taken.”
So, we can apply the same procedure as for the implant card in Switzerland and manufacturers will need to translate it according to the regional language needs, in a comprehensive way to make sure everything is understood by the intended user.
To ensure compliance with language requirements, it is the responsibility of manufacturers and distributors to engage professional translation companies that meet quality standards such as ISO 9001, ISO 17100, and the essential ISO 13485 for medical devices. These standards ensure accurate translations as mandated by the MDR requirements.
For high-risk Class III medical devices, it is particularly important to implement a medical translation process involving qualified translators. By taking these measures, manufacturers and distributors can uphold the necessary translation standards, thereby enhancing the safety and effectiveness of medical devices.
In conclusion, Switzerland's multilingualism poses challenges for medical device language requirements. The Medical Device Ordinance aligns with the EU's regulations, and Swissmedic oversees authorization and control. Product information must be in all three official languages, with exceptions for certain cases. Certificates of Conformity and Declarations of Conformity can be in official languages or English, with translation options. Implant cards must be in all three languages, while Field Safety Notices follow the language requirements of the Member State. Manufacturers should use professional medical device translation services to ensure compliance and accurate translations, particularly for high-risk devices, enhancing safety and effectiveness.
Adhering to language requirements is crucial for ensuring effective communication and user understanding of medical device information in Switzerland. By prioritizing accurate translations and complying with the language standards, manufacturers can contribute to the overall safety and quality of medical devices in the Swiss market.
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Alejandra Keller is a German and Spanish native speaker with a high level of proficiency in English. She holds a translation degree from the University of Heidelberg and has lived and studied in Germany, the United States, Ireland, Spain and Peru. With a strong passion for international communication, she is currently working as Project Manager at AbroadLink.