eIFU Compatibility Checker

If you are unsure if your medical device is compatible for use with eIFUs, you can use our compatibility checker.

Please note, this tool is a guide only. We advise that you make contact with us to discuss the results to ensure accuracy.

eIFU Regulations

Current US and EU regulations allow medical device manufacturers to use eIFUs with:

  • Active Implantable Devices and their accessories,
  • Implantable Devices and their accessories,
  • Fixed Installed Medical Devices,
  • Medical Devices and their accessories fitted with a built-in visual display screen
  • In Vitro Diagnostic Medical Devices

that are intended for Professional Users and sold within the US or EU.