Skip to main content

Instructions for Use and eIFUs

IFU Requirements​

Instructions for use (IFU) must accompany all medical devices except those for which safe use can be ensured without an IFU (typically simple Class I devices used by trained professionals). The IFU must be provided in German, French, and Italian for the Swiss market.

IFU content requirements are set out in MedDO Annex I § 23.4 and include: device identification; intended purpose; indications and contraindications; warnings and precautions; reprocessing instructions (for reusable devices); storage and transport conditions; shelf life; sterilisation instructions (if the user must sterilise); maintenance and calibration information; technical specifications.

Conditions for Providing an eIFU​

Under MedDO Art. 12 (Delegated Regulation (EU) 207/2012, applicable in Switzerland by reference), manufacturers may provide the IFU in electronic form (eIFU) instead of a paper IFU for certain devices, subject to:

  • The device is not intended for home use by lay persons (professional use only)
  • The manufacturer notifies Swissmedic before first placing the device on the Swiss market with an eIFU
  • A paper IFU is available free of charge on request to any user who requires one
  • The eIFU is accessible on the manufacturer's website and the website address is on the label

Swissmedic eIFU Notification​

Manufacturers must notify Swissmedic before switching from paper IFU to eIFU. The notification includes: device identification; confirmation of professional-use-only status; website URL where the eIFU will be accessible.

Official Sources​

Disclaimer

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