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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 through submission of the manufacturer statement prior to first supply; there is no formal DAPI or central registration system, but the statement must be filed and held available for inspection.