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Exemptions & Special Access

Devices Not Requiring MDACS Listing​

Certain devices are exempt from the listing requirement:

  • Custom-made devices — manufactured for individual patients (maintain essential principles documentation)
  • Devices for clinical investigation — research or clinical trial use only (apply for Waiver of Registration)
  • Exhibition/demonstration devices — not placed on the market (apply for Waiver of Registration)
  • Donated new devices — subject to Waiver of Registration conditions

Waiver of Registration (WOR)​

Institutions/researchers using exempt devices must apply for a WOR from the MDD:

  • Describe the device and its approved research/exhibition use
  • Confirm device will not be sold or placed on the market
  • Provide evidence of institutional ethics approval (for clinical investigations)
  • Post-WOR: report adverse events; do not supply to third parties beyond approved use

Compassionate Use​

Unregistered devices may be accessed on a named-patient basis in urgent circumstances where:

  • No MDACS-listed alternative is available
  • The patient has a serious/life-threatening condition
  • Appropriate hospital governance approval is in place