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Custom-made Devices

Overview​

A custom-made device is a device specifically made in accordance with a written prescription of a qualified practitioner, giving specific design characteristics, intended solely for a named patient. Custom-made devices are exempt from the standard conformity assessment procedure but must meet all applicable GSPRs and carry a manufacturer's statement instead of CE marking.

Key Requirements (MedDO Art. 50–52)​

  • No CE mark is required or permitted on custom-made devices
  • The manufacturer must prepare a statement containing: manufacturer details, device description and unique identifier of the patient, confirmation that the device meets the relevant GSPRs, and any deviations from the applicable standards with justification
  • The statement must be kept on file and provided to Swissmedic on request
  • Custom-made devices may only be supplied to the named patient

Swiss-Specific Considerations​

Swiss custom-made device statements must be prepared in accordance with MedDO Art. 51 requirements. Swissmedic has published a specific statement template. Custom-made devices are notified to Swissmedic — not via DAPI but through a separate notification process.

Official Sources​

Disclaimer

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

Manufacturers must submit the custom-made device statement to Swissmedic prior to first supply to the patient. The notification should include the manufacturer statement, device description, patient identifier (anonymised where permitted), and confirmation of GSPR compliance. Swissmedic maintains a registry of custom-made devices.