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Labelling Requirements

Overview​

The labelling of medical devices placed on the Swiss market must comply with MedDO Annex I § 23. A key Switzerland-specific requirement is that consumer-facing labelling and IFUs must be provided in German (DE), French (FR), and Italian (IT) — the three official national languages used for product labelling.

Mandatory Label Elements (MedDO Annex I § 23.2)​

All medical device labels must include at minimum:

  • Name or trade name of the device
  • Details necessary for users to identify the device and its contents
  • Manufacturer's name, address, and website
  • If the manufacturer is not established in Switzerland: CH REP name, address, and contact details
  • UDI (where required by class and timeline)
  • Lot, batch, or serial number
  • Manufacture date (and expiry date where applicable)
  • Instructions for use (or reference to IFU) — except for Class I devices where this may not be required
  • Any warnings or precautions
  • Purpose-specific symbols (ISO 15223)
  • CE marking (if applicable) and NB identification number
  • Country of origin (for sterile devices)
  • STERILE designation (if applicable)

Swiss Language Requirement​

For products placed on the Swiss consumer or professional market, labelling — including the IFU — must be provided in German, French, and Italian. English is not an official labelling language in Switzerland for consumer-facing materials, although professional/technical documentation may be in English where Swissmedic accepts this.

Important: This is a Swiss-specific requirement that differs from EU MDR, which requires the language of the EU member state where the device is marketed. Manufacturers placing devices on both EU and Swiss markets must ensure Swiss language compliance is addressed in addition to EU language requirements.

Labelling Symbols​

Device labels should use ISO 15223-1 symbols wherever applicable to reduce multilingual text requirements. Swissmedic has published a list of recognised symbols. Where symbols are used, their meaning must be explained in the IFU.

Official Sources​

Disclaimer

AI-assisted content for navigation only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.