Dear Nadine,
manufacturers that wish to place medical devices in the Swiss market shall list in the technical documentation the information required in Annexes II and III of the MDR.
If you manufacture custom-made devices it is possible to provide labelling and IFU in fewer languages or in English, but you need to attach to the product risk analysis a rationale explaining the reasons why you don't provide them in the three languages.
Best regards
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Valentina Faziani
Regulatory Affairs Specialist
Thema s.r.l.
Italy
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Original Message:
Sent: 30-May-2022 16:52
From: Nadine Adia
Subject: languages requested in Switzerland for labelling document and technical documentation
Dear Expert,
Base on your experience I need please your advise on the languages requested in Switzerland for labelling document and technical documentation.
Indeed , from The publication platform for federal law we should translate labelling document and instructions for use in the three official languages (German, French, Italian ).
The information on the device may be written in fewer than three official languages or only in English if the following conditions are met:
- the device is supplied exclusively to health professionals, it is a custom-made device or it is a device within the meaning of Article 9;
- the user has the necessary technical and linguistic skills and agrees that the information is not in the three official languages;
- the protection of patients, users and third parties is ensured;
- the efficient and effective use of the device is not compromised.
I' m wondering if we English is acceptable for technical documentation and if as Custom made device We should translate all our labelling documentation in the three official languages before placing the product on the market.
Thank you in advance for your reply.
Rgds,
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Nadine Adia
Quebec QC
Canada
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